360:(ANDA) with the Food and Drug Administration, seeking to demonstrate therapeutic equivalence to a previously approved "reference-listed drug" and proving that it can manufacture the drug safely and consistently. For an ANDA to be approved, the FDA requires that the 90% confidence interval of the geometric mean test/reference ratios for the total drug exposure (represented by the area under the curve or AUC) and the maximum plasma concentration (Cmax) should fall within limits of 80–125%. (This range is part of a statistical calculation, and does not mean that generic drugs are allowed to differ from their brand-name counterparts by up to 25 percent.) The FDA evaluated 2,070 studies conducted between 1996 and 2007 that compared the absorption of brand-name and generic drugs into a person's body. The average difference in absorption between the generic and the brand-name drug was 3.5 percent, comparable to the difference between two batches of a brand-name drug. Non-innovator versions of biologic drugs, or biosimilars, require clinical trials for
241:, in which the company is able to set the price of the drug at a level that maximizes profit. This profit often greatly exceeds the development and production costs of the drug, allowing the company to offset the cost of research and development of other drugs that are not profitable or do not pass clinical trials. The impact of loss of patent exclusivity on pharmaceutical products varies significantly across different product classes (e.g., biologics vs. small molecules), largely due to regulatory, legal and manufacturing hurdles associated with such products. Indeed, the greater degree of 'brand-brand' competitive dynamics seen in the biologics and complex generics space allows manufacturers of originators to better protect market share following loss of patent exclusivity.
1331:"Global Generic Drugs Market by Type (Simple Generic Drugs, super Generic drugs, Biosimilar), Application (Anti-infective, Cardiovascular, Central Nervous System, Diabetes, Oncology, Respiratory, Rheumatology), and Region (North America (U.S., Canada, Mexico), Europe (Germany, France, U.K., Russia, Spain, Italy, Benelux, Rest of Europe), Asia Pacific (China, Japan, India, South Korea, Australia, ASEAN, Rest of Asia Pacific), Latin America (Brazil, Argentina, Chile, and Rest of Latin America), and Middle East and Africa (GCC, Turkey, and South America) Growth, Trends, Covid-19 Impact, And Forecasts (2022-2028)"
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a "scalloped" curve, which usually starts at the brand-name price on the day of generic launch and then falls as competition intensifies. After some years, the graph typically flattens out at approximately 20% of the original brand price. In about 20% of cases, the price "bounces": Some license holders withdraw from the market when the selling price dips below their cost of goods, and the price then rises for a while until the license holders re-enter the market with new stock. The NHS spent about £4.3 billion on generic medicines in 2016–17.
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410:. The right of individuals or organizations to petition the federal government is guaranteed by the First Amendment to the United States Constitution. For this reason, the FDA has promulgated regulations that provide, among other things, that at any time, any "interested person" can request that the FDA "issue, amend, or revoke a regulation or order," and set forth a procedure for doing so.
353:, informally known as the Hatch–Waxman Act, standardized procedures for recognition of generic drugs. In 2007, the FDA launched the Generic Initiative for Value and Efficiency (GIVE): an effort to modernize and streamline the generic drug approval process, and to increase the number and variety of generic products available.
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Problems with the quality of generic drugs – especially those produced outside the United States – are widespread as of 2019. The FDA does infrequent – less than annual – inspections of production sites outside the United States. The FDA normally gives advance notice of inspections, which can lead to
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When faced with patent litigation from the drug innovator or patent holder, generic companies will often counter-sue, challenging the validity of the patent. Like any litigation between private parties, the innovator and generic companies may choose to settle the litigation. Some of these settlement
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In the United
Kingdom, generic drug pricing is controlled by the government's reimbursement rate. The price paid by pharmacists and doctors is determined mainly by the number of license holders, the sales value of the original brand, and the ease of manufacture. A typical price decay graph will show
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Generic drug companies may also receive the benefit of the previous marketing efforts of the brand-name company, including advertising, presentations by drug representatives, and distribution of free samples. Many drugs introduced by generic manufacturers have already been on the market for a decade
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A series of scandals around the approval of generic drugs in the late 1980s shook public confidence in generic drugs; there were several instances in which companies obtained bioequivalence data fraudulently, by using the branded drug in their tests instead of their own product, and a congressional
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India is a leading country in the world's generic drugs market, exporting US$ 20.0 billion worth of drugs in the 2019–20 (April–March) year. India exports generic drugs to the United States and the
European Union. also the according to market research community the Global Generic Drugs Market was
244:
Large pharmaceutical companies often spend millions protecting their patents from generic competition. Apart from litigation, they may reformulate a drug or license a subsidiary (or another company) to sell generics under the original patent. Generics sold under license from the patent holder are
62:. Generic drugs are allowed for sale after the patents on the original drugs expire. Because the active chemical substance is the same, the medical profile of generics is equivalent in performance compared to their performance at the time when they were patented drugs. A generic drug has the same
501:
began encouraging more drug manufacturing by Indian companies in the early 1960s, and with the
Patents Act in 1970. The Patents Act removed composition patents for foods and drugs, and though it kept process patents, these were shortened to a period of five to seven years. The resulting lack of
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In order to start selling a drug promptly after the patent on innovator drug expires, a generic company has to file its ANDA well before the patent expires. This puts the generic company at risk of being sued for patent infringement, since the act of filing the ANDA is considered "constructive
430:
showed that replacing
Coumadin with generic warfarin was safe, but many physicians are not comfortable with their patients taking branded generic equivalents. In some countries (for example, Australia) where a drug is prescribed under more than one brand name, doctors may choose not to allow
136:
protections afforded to the drug's original developer expire. Once generic drugs enter the market, competition often leads to substantially lower prices for both the original brand-name product and its generic equivalents. In most countries, patents give 20 years of protection. However, many
309: may be used, for instance. Different inactive ingredients means that the generic may look different from the originator brand. However, the therapeutic effect of the drug must be the same ("pharmaceutical alternative"). Most small molecule drugs are accepted as bioequivalent if their
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as "products that are (a) either novel dosage forms of off-patent products produced by a manufacturer that is not the originator of the molecule, or (b) a molecule copy of an off-patent product with a trade name." Since the company making branded generics can spend little on
379:
list and annotates the list to show the equivalence between the reference-listed drug and the generic. The FDA also recognizes drugs that use the same ingredients with different bioavailability and divides them into therapeutic equivalence groups. For example, as of 2006,
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have active pharmaceutical ingredients that are almost identical to the original product and are typically regulated under an extended set of rules, but they are not the same as generic drugs as the active ingredients are not the same as those of their reference products.
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in the pharmaceutical industry; patented drugs with sales of around US$ 28 billion were set to come off patent in 2018, but in 2019 only about US$ 10 billion in revenue was set to open for competition, and less the next year. Companies in the industry have responded with
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Although they may not be associated with a particular company, generic drugs are usually subject to government regulations in the countries in which they are dispensed. They are labeled with the name of the manufacturer and a generic non-proprietary name such as the
1386:
1496:"WHO Expert Committee on Specifications for Pharmaceutical Preparations, Fortieth Report (WHO Technical Report Series No. 937): Annex 7 – Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability"
2084:
256:. One reason for this is that competition increases among producers when a drug is no longer protected by patents. Generic companies incur fewer costs in creating generic drugs—only the cost of manufacturing, without the costs of
388:
infringement" of the patent. In order to incentivize generic companies to take that risk the Hatch-Waxman act granted a 180-day administrative exclusivity period to generic drug manufacturers who are the first to file an ANDA.
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In 1945–2017, bioequivalence studies were only required for generics of drugs that are less than four years old. Since 2017, all generic drugs of certain classes, irrespective of age, require bioequivalence to be approved.
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467:
cover-ups of problems before inspectors arrive; inspections performed with little or no advance notice have produced evidence of serious problems at a majority of generic drug manufacturing sites in India and China.
763:
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patent protection created a niche in both the Indian and global markets that Indian companies filled by reverse-engineering new processes for manufacturing low-cost drugs. The code of ethics issued by the
376:
221:(including the costs of the drug candidates that fail) and to make a profit. The average cost to a brand-name company of discovering, testing, and obtaining regulatory approval for a new drug, with a
364:
in addition to tests establishing bioequivalency. These products cannot be entirely identical because of batch-to-batch variability and their biological nature, and they are subject to extra rules.
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agreements, in which the generic company basically accepts a payment to drop the litigation, delaying the introduction of the generic product and frustrating the purpose of the Hatch–Waxman Act.
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Generic drug production is a large part of the pharmaceutical industry in China. Western observers have said that China lacks administrative protection for patents. However, entry to the
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dissolution behavior is required to match. Since 2018, 44 classes of drugs are exempt from testing (requiring only a dissolution check), and 13 classes only require simplified testing.
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In 2012, 84 percent of prescriptions in the US were filled with generic drugs, and in 2014, the use of generic drugs in the United States led to US$ 254 billion in health care savings.
1285:
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350:
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In 2014, according to an analysis by the
Generic Pharmaceutical Association, generic drugs accounted for 88 percent of the 4.3 billion prescriptions filled in the United States.
403:; a 2011 FTC report found that consumers benefitted from lower costs when an authorized generic was introduced during the 180 day exclusivity period, as it created competition.
237:" by critics, but at some point there is no patent protection available. For as long as a drug patent lasts, a brand-name company enjoys a period of market exclusivity, or
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Bioequivalence does not mean generic drugs must be exactly the same as the brand-name product ("pharmaceutical equivalent"). Chemical differences may exist; a different
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661:
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investigation found corruption at the FDA, where employees were accepting bribes to approve some generic companies' applications and delaying or denying others.
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Every physician should, as far as possible, prescribe drugs with generic names and he / she shall ensure that there is a rational prescription and use of drugs.
217:. Pharmaceutical companies that develop new drugs generally only invest in drug candidates with strong patent protection as a strategy to recoup their costs of
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1210:
742:
2412:
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2918:["Species that can be exempted or simplified from human bioequivalence testing (BE)": 44 exempted BE varieties, 13 simplified BE varieties list].
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being the largest pharmaceutical company in India. Indian generics companies exported US$ 17.3 billion worth of drugs in the 2017–18 (April–March) year.
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in 2002 calls for physicians to prescribe drugs by their generic names only. India is a leading country in the world's generic drugs market, with
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Most developed nations require generic drug manufacturers to prove that their formulations are bioequivalent to their brand-name counterparts.
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Innovator companies sometimes try to maintain some of the revenue from their drug after patents expire by allowing another company to sell an
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145:, may grant up to five years of additional protection ("patent term restoration") if manufacturers meet specific goals, such as conducting
1905:"Comparing generic and innovator drugs: a review of 12 years of bioequivalence data from the United States Food and Drug Administration"
1706:"Comparing Generic and Innovator Drugs: A Review of 12 Years of Bioequivalence Data from the United States Food and Drug Administration"
605:
2281:
2215:
2017:"Guidance for Industry: 180-Day Generic Drug Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act"
2978:
2016:
787:
621:
483:, the court held that generic companies cannot be held liable for information, or the lack of information, on the originator's label.
1662:
Page A, Etherton-Beer C (January 2018). "Choosing a medication brand: Excipients, food intolerance and prescribing in older people".
2241:"Authorized Generic Drugs: Short-Term Effects and Long-Term ImpactAuthorized Generic Drugs: Short-Term Effects and Long-Term Impact"
803:
691:
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91:
83:
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2001:
175:, it is able to spend on marketing alone, thus earning higher profits and driving costs down. For example, the largest revenues of
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63:
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Manufacturers, wholesalers, insurers, and drugstores can all increase prices at various stages of production and distribution.
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Bioequivalence studies are required for new generic drugs starting from 2016, with older drugs planned as well. In addition,
460:
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evaluated US$ 465.96 million in 2021 and is expected to rise with a CAGR of 5.5% from 2022- 2028 during the forecast period.
426:
and requires frequent blood tests to make sure patients do not have a subtherapeutic or a toxic level. A study performed in
2747:
Haley GT, Haley UC (2012). "The effects of patent-law changes on innovation: The case of India's pharmaceutical industry".
1495:
3009:
1889:
831:
811:
1636:
1554:
953:
444:
1052:
DiMasi JA, Hansen RW, Grabowski HG (March 2003). "The price of innovation: new estimates of drug development costs".
879:
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had four equivalence groups, all using the same active ingredient, but considered equivalent only within each group.
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2850:"Disciplining China's Trade Practices at the WTO: How WTO Complaints Can Help Make China More Market-Oriented"
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Innovator companies may also present arguments to the FDA that the ANDA should not be accepted by filing an
167:
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854:
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of 80–125%; most approved generics in the US are well within this limit. For more complex products—such as
3099:
1106:
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or more and may already be well known to patients and providers, although often under their branded name.
252:
Generic drugs are usually sold for significantly lower prices than their branded equivalents and at lower
233:
strategies they use to extend their exclusivity, some of which are seen as gaming the system and labeled "
230:
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at a lower price. The prices are often low enough for users in less-prosperous countries to afford them.
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117:
463:, were withdrawn from the US market after the FDA determined in 2012 that they were not bioequivalent.
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pharmacists to substitute a brand different from the one prescribed unless the consumer requests it.
407:
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66:(API) as the original, but it may differ in some characteristics such as the manufacturing process,
2322:"Are brand-name and generic warfarin interchangeable? Multiple n-of-1 randomized, crossover trials"
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326:
318:
246:
222:
214:
121:
55:
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2551:"FDA Update: Budeprion XL 300 mg Not Therapeutically Equivalent to Wellbutrin XL 300 mg"
2373:"Are brand-name and generic warfarin interchangeable? A survey of Ontario patients and physicians"
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Two women, each claiming to have suffered severe medical complications from a generic version of
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400:
341:, or biosimilar drugs—demonstrating pharmacodynamic or clinical equivalence is more challenging.
265:
611:
1531:. 1 April 2008. Code of Federal Regulations 320 Title 21, Volume 5 CFR 320 21/5. Archived from
551:
As of 2021, several major companies traditionally dominate the generic drugs market, including
30:
2974:
2663:
2387:
2371:
Pereira JA, Holbrook AM, Dolovich L, Goldsmith C, Thabane L, Douketis JD, et al. (2005).
2341:
2320:
Pereira JA, Holbrook AM, Dolovich L, Goldsmith C, Thabane L, Douketis JD, et al. (2005).
2173:
2169:
1983:
1924:
1903:
Davit BM, Nwakama PE, Buehler GJ, Conner DP, Haidar SH, Patel DT, et al. (October 2009).
1842:
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87:
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1005:
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580:
575:. Prices in traditional generic drugs have declined and newer companies such as India-based
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261:
218:
103:
99:
59:
2257:
1800:
2997:"United States Adopted Names Program, generic drug naming process, lists of adopted names"
2433:
2417:
Pharmaceutical
Society of Australia Competency Standards for Pharmacists in Australia 2003
641:
310:
286:
In the mid-2010s the generics industry began transitioning to the end of an era of giant
2645:
2109:
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1978:
1951:
1867:. U.S. Food and Drug Administration Center for Drug Evaluation and Research. 2009-06-18
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1752:
1445:"Development of the generic drug industry in the US after the Hatch-Waxman Act of 1984"
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95:
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1065:
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2042:"Paragraph IV Drug Product Applications: Generic Drug Patent Challenge Notifications"
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1162:
906:"FDA White Paper: Generic Drug Prices in the US Are Lower Than Drug Prices in Canada"
905:
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253:
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that, until it expires, the company can use to exclude competitors by suing them for
142:
58:
that contains the same chemical substance as a drug that was originally protected by
2353:
1936:
1737:
1675:
1311:"India could 'withdraw' curbs on drug exports as pharma firms fear loss of business"
2760:
287:
234:
2733:
1828:"Overview of the Hatch-Waxman Act and its impact on the drug development process"
2819:
1358:"Price decay after loss of brand exclusivity (patent expiry) and generic launch"
17:
2413:"Generic medicines training kit: safe and appropriate use of generic medicines"
1753:"Generics, chemisimilars and biosimilars: is clinical testing fit for purpose?"
1461:
1444:
1145:
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2395:
592:
572:
507:
180:
150:
125:
1952:"Biosimilars: company strategies to capture value from the biologics market"
1865:
Approved Drug
Products with Therapeutic Equivalence Evaluations 29th Edition
1640:
1236:"The role of reverse engineering in the development of generic formulations"
1099:"Cost to Develop and Win Marketing Approval for a New Drug Is $ 2.6 Billion"
1000:
532:
has brought a stronger patent system. China remains the largest exporter of
452:
381:
201:
that distinguish drugs between and within classes and suggest their action.
71:
2391:
2345:
2148:
Elhauge E, Krueger A (2012-12-21). "Solving the Patent
Settlement Puzzle".
2063:"Bristol-Myers Squibb press release on successful defense of Plavix patent"
1987:
1928:
1846:
1786:
1729:
1683:
1478:"Glenmark's Glenn Saldanha seeks a new holy grail as generic drugs run dry"
1154:
1083:
1019:
2875:"The world needs pharmaceuticals from China and India to beat coronavirus"
2041:
2002:"Approved Drug Products with Therapeutic Equivalence Evaluations, Preface"
1529:
U.S. Food and Drug
Administration, Department of Health and Human Services
715:"What's the difference between brand-name and generic prescription drugs?"
209:
When a pharmaceutical company first markets a drug, it is usually under a
2157:
1315:
568:
419:
338:
238:
2419:. National Prescribing Service Limited (NPS). 2003-07-09. Archived from
1614:
1286:"Exclusive: With U.S. trade under a cloud, China opens to Indian pharma"
552:
479:, lost their Supreme Court appeal on June 23, 2011. In a 5–4 ruling in
427:
330:
226:
176:
2828:
2337:
2218:. U.S. Federal Trade Administration (FTC). August 2011. Archived from
1968:
1920:
1721:
1074:
739:"Food & Drug Administration, Generic Drugs: Questions and Answers"
418:
Some generic drugs are viewed with suspicion by doctors. For example,
392:
agreements have been struck down by courts when they took the form of
375:
When an application is approved, the FDA adds the generic drug to its
1861:"Orange Book Annual Preface, Statistical Criteria for Bioequivalence"
1637:"National Institute for Health Sciences, Division of Drugs Guidances"
588:
560:
225:, was estimated to be as much as US$ 800 million in 2003 and US$ 2.6
210:
133:
39:
35:
1904:
1705:
1097:
Tufts Center for the Study of Drug
Development (November 18, 2014).
2897:"China FDA lays down new guidelines on bioequivalence for generics"
2527:"Generic antidepressant pulled from U.S. shelves after FDA finding"
2487:"F.D.A. Inquiry on Generic Drugs Focuses on Changes in Ingredients"
94:(FDA) requires generics to be identical to or within an acceptable
2996:
606:
Anti-Counterfeiting Trade Agreement#Criminalising generic medicine
556:
451:
began reporting on consumers' complaints that generic versions of
366:
306:
198:
29:
1179:. Generic Pharmaceutical Association (GPhA). 2008. Archived from
860:. Washington, DC: Generic Pharmaceutical Association (GPhA). 2015
3014:
2106:"Apotex press release on successful challenge of Norvasc patent"
2022:. FDA, Center for Drug Evaluation and Research (CDER). June 1998
656:
356:
Before a company can market a generic drug, it needs to file an
3041:
2815:"China's Pharmaceutical Industry Lacks Innovation, Lags Behind"
1704:
Davit BM, Nwakama PE, Buehler GJ, Conner DP, Haidar SH (2009).
1555:"Drugs and Health Products, Bioavailability and Bioequivalence"
377:
Approved Drug Products with Therapeutic Equivalence Evaluations
3073:"Canada Generic Drugs: Government of Canada and Health Canada"
2797:"India makes a long overdue move to ensure better drug safety"
2705:
2131:"Apotex press release on successful challenge of Paxil patent"
1581:"The Rules Governing Medicinal Products in the European Union"
536:, accounting for 40% of the world market per a 2017 estimate.
163:
3057:
1129:"Patent Cliffs in the Era of Complex Therapies and Biologics"
455:(Wellbutrin) were yielding unexpected effects. Subsequently,
229:
in 2014. Drug companies that bring new products have several
2702:"High Court sides with generic drug makers in narrow ruling"
2189:"Supreme Court Lets Regulators Sue Over Generic Drug Deals"
1525:"Part 320--Bioavailability and Bioequivalence Requirements"
1207:"Savings From Generic Drugs Purchased at Retail Pharmacies"
132:
In most cases, generic products become available after the
2683:"Generic Pharmaceutical Liability: Challenges And Changes"
1267:"What it takes to be called 'big pharma' – Market Realist"
2436:
by ticking the relevant box on the PBS prescription form"
2580:"Americans Need Generic Drugs. But Can They Trust Them?"
162:"Branded generics" on the other hand are defined by the
106:
properties. (The FDA's use of the word "identical" is a
98:
range of their brand-name counterparts, with respect to
86:(INN) of the drug. A generic drug must contain the same
2246:. U.S. Federal Trade Administration (FTC). August 2011.
1950:
Calo-Fernández B, Martínez-Hurtado JL (December 2012).
1419:"No-deal Brexit 'will force up price of generic drugs'"
912:. 6.US Food and Drug Administration, Office of Planning
591:, have taken market share, which has led to a focus on
42:, more than 20% of all drug sales in units are generic.
351:
Drug Price Competition and Patent Term Restoration Act
197:
Generic drug names are constructed using standardized
459:'s 300 mg extended-release tablets, marketed by
2573:
2571:
1801:"Generic Initiative for Value and Efficiency (GIVE)"
1337:. Reports Insights Consulting Pvt Ltd. 29 April 2022
982:Gupta H, Kumar S, Roy SK, Gaud RS (January 2010).
2081:"Bristol-Myers Squibb - Newsroom - News Releases"
1443:Boehm G, Yao L, Han L, Zheng Q (September 2013).
849:
847:
27:Pharmaceutical equivalent to a brand-name product
2775:"Code of Medical Ethics Regulations, 2002 | NMC"
2044:. FDA, Office of Generic Drugs (OGD). 2008-06-11
1035:"How Patent Law Can Block Even Lifesaving Drugs"
932:"Branded Generics: Misunderstood, but Lucrative"
2916:"《可豁免或简化人体生物等效性试验(BE)品种》：44个豁免BE品种，13个简化BE品种名单"
977:
975:
3042:"The Medical Letter on Drugs and Therapeutics"
2505:"Drug Tests: Wellbutrin vs. Generic Bupropion"
662:Transatlantic Trade and Investment Partnership
2664:"Drug Makers Win Two Supreme Court Decisions"
2380:The Canadian Journal of Clinical Pharmacology
1438:
1436:
1403:"Getting to the bottom of 'bouncing' price".
8:
2006:– an explanation of FDA terms and procedures
1503:WHO Technical Report Series No. 937: Annex 7
988:Journal of Pharmacy & Bioallied Sciences
90:as the original brand-name formulation. The
2749:Technological Forecasting and Social Change
1421:. Health Service Journal. 26 September 2018
832:"An insider's view of generic-drug pricing"
2971:Generic: The Unbranding of Modern Medicine
2934:"Top Global Pharmaceutical Company Report"
1821:
1819:
1817:
1201:
1199:
1197:
1977:
1967:
1776:
1460:
1144:
1073:
1009:
999:
826:
824:
822:
764:"Biosimilar and Interchangeable Products"
657:SOPA#Protection against counterfeit drugs
295:or turning to try to generate new drugs.
3030:"UK Department of Health, generic drugs"
1757:British Journal of Clinical Pharmacology
2282:"Citizen Petitions: An Empirical Study"
1376:"Guessing at prices means losing money"
804:"Pediatric Research Equity Act of 2007"
709:
707:
688:Center for Drug Evaluation and Research
673:
1392:from the original on 9 September 2016.
1284:Dasgupta N, Miglani S (12 July 2018).
954:"Big Pharma Embraces Branded Generics"
2216:"#223: Authorized Generic Drug Study"
7:
2004:. U.S. Food and Drug Administration.
1127:Sabatini MT, Silva M (August 2020).
264:—and are therefore able to maintain
3054:Generic Pharmaceutical Association"
2823:, Washington, D.C., United States:
2465:Freudenheim M (10 September 1989).
2448:"Bolar: A Drug Company Under Siege"
137:countries and regions, such as the
2642:Supreme Court of the United States
622:Generic pharmaceutical price decay
25:
2555:U.S. Food and Drug Administration
1559:Health Canada, Guidance Documents
855:"Generic Drug Savings in the U.S"
768:U.S. Food and Drug Administration
692:U.S. Food and Drug Administration
627:International Nonproprietary Name
534:active pharmaceutical ingredients
394:reverse payment patent settlement
92:U.S. Food and Drug Administration
84:International Nonproprietary Name
3005:"USFDA, Office of Generic Drugs"
2827:, worldwatch.org, archived from
2446:Strickland C (15 October 1989).
1769:10.1111/j.1365-2125.2012.04323.x
1689:
934:. Pharmacy Times. 1 October 2008
524:Pharmaceutical industry in China
493:Pharmaceutical industry in India
358:Abbreviated New Drug Application
64:active pharmaceutical ingredient
1676:10.1016/j.maturitas.2017.11.001
74:, color, taste, and packaging.
2761:10.1016/j.techfore.2011.05.012
1360:. PharmaPhorum. Archived from
1265:Benson M (February 20, 2015).
984:"Patent protection strategies"
886:. Food and drug administration
461:Teva Pharmaceutical Industries
183:, came from branded generics.
1:
2326:The Annals of Pharmacotherapy
2280:Carrier MA, Wander D (2012).
1909:The Annals of Pharmacotherapy
1066:10.1016/s0167-6296(02)00126-1
1033:Frakt A (28 September 2015).
3010:Food and Drug Administration
1890:Food and Drug Administration
1561:. Health Canada. 8 June 2005
1476:Altstedter A (18 May 2017).
1213:. April 2004. Archived from
1211:Food and Drug Administration
812:Food and Drug Administration
743:Food and Drug Administration
2779:National Medical Commission
2681:Casey S (24 October 2012).
2485:Andrews EL (31 July 1989).
1886:"Facts about Generic Drugs"
1611:"European Medicines Agency"
1449:Acta Pharmaceutica Sinica B
1054:Journal of Health Economics
445:North Carolina Public Radio
120:, differ biologically from
34:In some countries, such as
3121:
2795:Reddy P (April 12, 2017).
2432:"Prescribers may disallow
1751:Warren JB (January 2013).
1462:10.1016/j.apsb.2013.07.004
1356:Joynson C (4 April 2012).
1146:10.1007/s40290-020-00348-7
587:, as well as Canada-based
521:
490:
190:
80:United States Adopted Name
2895:Lane EJ (16 March 2016).
2662:Liptak A (23 June 2011).
2295:: 249–293. Archived from
1835:Food and Drug Law Journal
1710:Annals of Pharmacotherapy
1335:Market Research Community
2606:"PLIVA, Inc. v. Mensing"
2187:Wyatt E (17 June 2013).
1911:(Submitted manuscript).
1712:(Submitted manuscript).
585:Dr. Reddy's Laboratories
530:World Trade Organization
504:Medical Council of India
422:(Coumadin) has a narrow
173:research and development
3090:Pharmaceutical industry
1826:Mossinghoff GJ (1999).
1639:. Japan. Archived from
1133:Pharmaceutical Medicine
1001:10.4103/0975-7406.62694
382:diltiazem hydrochloride
168:National Health Service
3105:Life sciences industry
3095:Pharmaceuticals policy
2726:"The Patent Act, 1970"
2700:Mears B (2011-06-23).
2644:. 2011. Archived from
2633:PLIVA, Inc. v. Mensing
2578:Eban K (11 May 2019).
2525:Healy M (2012-10-05).
1803:. FDA. October 4, 2007
880:"FAQ on generic drugs"
481:PLIVA, Inc. v. Mensing
372:
371:Generic Drugs Research
339:liposomal preparations
335:patch delivery systems
231:product line extension
43:
2467:"Exposing the F.D.A."
1177:"Authorized Generics"
637:Medicines Patent Pool
569:Novartis' Sandoz
449:The People's Pharmacy
370:
349:Enacted in 1984, the
319:maximum concentration
118:monoclonal antibodies
33:
2831:on December 26, 2018
2825:Worldwatch Institute
2158:10.2139/ssrn.2125456
408:FDA citizen petition
315:area under the curve
122:small-molecule drugs
108:legal interpretation
2914:Ye W (2017-11-13).
2730:www.ircc.iitb.ac.in
1364:on 31 January 2013.
719:Scientific American
632:Inverse benefit law
508:Sun Pharmaceuticals
327:confidence interval
325:) are within a 90%
247:authorized generics
223:new chemical entity
215:patent infringement
56:pharmaceutical drug
2736:on April 30, 2010.
2585:The New York Times
2491:The New York Times
2471:The New York Times
2452:The New York Times
2332:(7–8): 1188–1193.
2289:Cardozo Law Review
2137:on August 7, 2007.
1385:: 10. 8 Sep 2006.
1246:on 18 October 2020
1240:www.clihouston.com
1039:The New York Times
745:. January 12, 2010
683:Generic Drug Facts
652:Research exemption
647:Prescription costs
457:Impax Laboratories
424:therapeutic window
401:authorized generic
373:
114:Biopharmaceuticals
88:active ingredients
44:
2999:. 16 August 2023.
2531:Los Angeles Times
2338:10.1345/aph.1G003
2270:21 C.F.R. Part 10
2258:"First Amendment"
1969:10.3390/ph5121393
1962:(12): 1393–1408.
1921:10.1345/aph.1m141
1915:(10): 1583–1597.
1722:10.1345/aph.1m141
1716:(10): 1583–1597.
1405:Generics Bulletin
1383:Generics Bulletin
840:. March 25, 2013.
837:Los Angeles Times
499:Indian government
193:Drug nomenclature
16:(Redirected from
3112:
3076:
3068:
3066:
3065:
3056:. Archived from
3045:
3037:
3032:. Archived from
3025:
3023:
3022:
3013:. Archived from
3000:
2984:
2953:
2952:
2950:
2948:
2938:
2930:
2924:
2923:
2920:贤集网 (Xianji.com)
2911:
2905:
2904:
2892:
2886:
2885:
2883:
2882:
2871:
2865:
2864:
2862:
2861:
2846:
2840:
2839:
2838:
2836:
2811:
2805:
2804:
2792:
2786:
2785:
2771:
2765:
2764:
2744:
2738:
2737:
2732:. Archived from
2722:
2716:
2715:
2713:
2712:
2697:
2691:
2690:
2678:
2672:
2671:
2659:
2653:
2652:
2650:
2639:
2627:
2621:
2620:
2618:
2616:
2602:
2596:
2595:
2593:
2592:
2575:
2566:
2565:
2563:
2562:
2547:
2541:
2540:
2538:
2537:
2522:
2516:
2515:
2513:
2512:
2501:
2495:
2494:
2482:
2476:
2475:
2462:
2456:
2455:
2443:
2437:
2431:
2429:
2428:
2409:
2403:
2402:
2400:
2394:. Archived from
2386:(3): e229–e239.
2377:
2368:
2362:
2361:
2356:. Archived from
2317:
2311:
2310:
2308:
2307:
2301:
2286:
2277:
2271:
2268:
2262:
2261:
2254:
2248:
2247:
2245:
2237:
2231:
2230:
2228:
2227:
2212:
2206:
2205:
2203:
2201:
2184:
2178:
2177:
2150:Texas Law Review
2145:
2139:
2138:
2133:. Archived from
2127:
2121:
2120:
2118:
2117:
2108:. Archived from
2102:
2096:
2095:
2093:
2092:
2083:. Archived from
2077:
2071:
2070:
2065:. Archived from
2059:
2053:
2052:
2050:
2049:
2038:
2032:
2031:
2029:
2027:
2021:
2013:
2007:
2005:
1998:
1992:
1991:
1981:
1971:
1947:
1941:
1940:
1900:
1894:
1893:
1892:. 26 April 2019.
1882:
1876:
1875:
1873:
1872:
1857:
1851:
1850:
1832:
1823:
1812:
1811:
1809:
1808:
1797:
1791:
1790:
1780:
1748:
1742:
1741:
1701:
1695:
1694:
1693:
1687:
1659:
1653:
1652:
1650:
1648:
1633:
1627:
1626:
1624:
1622:
1613:. Archived from
1607:
1601:
1600:
1598:
1596:
1587:. Archived from
1577:
1571:
1570:
1568:
1566:
1551:
1545:
1544:
1542:
1540:
1521:
1515:
1514:
1512:
1510:
1500:
1492:
1486:
1485:
1473:
1467:
1466:
1464:
1440:
1431:
1430:
1428:
1426:
1415:
1409:
1408:
1400:
1394:
1393:
1391:
1380:
1372:
1366:
1365:
1353:
1347:
1346:
1344:
1342:
1327:
1321:
1320:
1307:
1301:
1300:
1298:
1296:
1281:
1275:
1274:
1262:
1256:
1255:
1253:
1251:
1242:. Archived from
1232:
1226:
1225:
1223:
1222:
1203:
1192:
1191:
1189:
1188:
1173:
1167:
1166:
1148:
1124:
1118:
1117:
1115:
1114:
1105:. Archived from
1103:Tufts University
1094:
1088:
1087:
1077:
1049:
1043:
1042:
1030:
1024:
1023:
1013:
1003:
979:
970:
969:
967:
965:
950:
944:
943:
941:
939:
928:
922:
921:
919:
917:
902:
896:
895:
893:
891:
876:
870:
869:
867:
865:
859:
851:
842:
841:
828:
817:
816:
808:
800:
794:
792:§ 154(a)(2)
785:
779:
778:
776:
774:
760:
754:
753:
751:
750:
735:
729:
728:
726:
725:
711:
702:
701:
700:
699:
678:
581:Aurobindo Pharma
262:drug development
219:drug development
110:, not literal.)
60:chemical patents
21:
18:Generic medicine
3120:
3119:
3115:
3114:
3113:
3111:
3110:
3109:
3080:
3079:
3071:
3063:
3061:
3048:
3040:
3028:
3020:
3018:
3003:
2995:
2992:
2987:
2981:
2965:
2961:
2959:Further reading
2956:
2946:
2944:
2943:. November 2021
2941:The Pharma 1000
2936:
2932:
2931:
2927:
2913:
2912:
2908:
2894:
2893:
2889:
2880:
2878:
2873:
2872:
2868:
2859:
2857:
2848:
2847:
2843:
2834:
2832:
2813:
2812:
2808:
2794:
2793:
2789:
2773:
2772:
2768:
2746:
2745:
2741:
2724:
2723:
2719:
2710:
2708:
2699:
2698:
2694:
2680:
2679:
2675:
2661:
2660:
2656:
2648:
2637:
2629:
2628:
2624:
2614:
2612:
2604:
2603:
2599:
2590:
2588:
2577:
2576:
2569:
2560:
2558:
2549:
2548:
2544:
2535:
2533:
2524:
2523:
2519:
2510:
2508:
2503:
2502:
2498:
2484:
2483:
2479:
2464:
2463:
2459:
2445:
2444:
2440:
2434:brand switching
2426:
2424:
2411:
2410:
2406:
2398:
2375:
2370:
2369:
2365:
2319:
2318:
2314:
2305:
2303:
2299:
2284:
2279:
2278:
2274:
2269:
2265:
2256:
2255:
2251:
2243:
2239:
2238:
2234:
2225:
2223:
2214:
2213:
2209:
2199:
2197:
2186:
2185:
2181:
2147:
2146:
2142:
2129:
2128:
2124:
2115:
2113:
2104:
2103:
2099:
2090:
2088:
2079:
2078:
2074:
2061:
2060:
2056:
2047:
2045:
2040:
2039:
2035:
2025:
2023:
2019:
2015:
2014:
2010:
2000:
1999:
1995:
1956:Pharmaceuticals
1949:
1948:
1944:
1902:
1901:
1897:
1884:
1883:
1879:
1870:
1868:
1859:
1858:
1854:
1830:
1825:
1824:
1815:
1806:
1804:
1799:
1798:
1794:
1750:
1749:
1745:
1703:
1702:
1698:
1688:
1661:
1660:
1656:
1646:
1644:
1635:
1634:
1630:
1620:
1618:
1609:
1608:
1604:
1594:
1592:
1579:
1578:
1574:
1564:
1562:
1553:
1552:
1548:
1538:
1536:
1523:
1522:
1518:
1508:
1506:
1498:
1494:
1493:
1489:
1475:
1474:
1470:
1442:
1441:
1434:
1424:
1422:
1417:
1416:
1412:
1402:
1401:
1397:
1389:
1378:
1374:
1373:
1369:
1355:
1354:
1350:
1340:
1338:
1329:
1328:
1324:
1319:. 6 March 2020.
1309:
1308:
1304:
1294:
1292:
1283:
1282:
1278:
1264:
1263:
1259:
1249:
1247:
1234:
1233:
1229:
1220:
1218:
1205:
1204:
1195:
1186:
1184:
1175:
1174:
1170:
1126:
1125:
1121:
1112:
1110:
1096:
1095:
1091:
1051:
1050:
1046:
1032:
1031:
1027:
981:
980:
973:
963:
961:
952:
951:
947:
937:
935:
930:
929:
925:
915:
913:
904:
903:
899:
889:
887:
878:
877:
873:
863:
861:
857:
853:
852:
845:
830:
829:
820:
806:
802:
801:
797:
786:
782:
772:
770:
762:
761:
757:
748:
746:
737:
736:
732:
723:
721:
713:
712:
705:
697:
695:
680:
679:
675:
671:
666:
642:Me-too compound
601:
549:
526:
520:
495:
489:
473:
437:
416:
347:
324:
311:pharmacokinetic
207:
195:
189:
179:, now owned by
147:clinical trials
104:pharmacodynamic
100:pharmacokinetic
28:
23:
22:
15:
12:
11:
5:
3118:
3116:
3108:
3107:
3102:
3097:
3092:
3082:
3081:
3078:
3077:
3069:
3046:
3038:
3036:on 2007-03-01.
3026:
3001:
2991:
2990:External links
2988:
2986:
2985:
2980:978-1421414935
2979:
2962:
2960:
2957:
2955:
2954:
2925:
2906:
2887:
2866:
2854:Cato Institute
2841:
2806:
2787:
2766:
2755:(4): 607–619.
2739:
2717:
2692:
2673:
2668:New York Times
2654:
2651:on 2013-05-12.
2622:
2597:
2567:
2542:
2517:
2496:
2477:
2457:
2438:
2404:
2401:on 2007-11-29.
2363:
2360:on 2011-06-16.
2312:
2272:
2263:
2249:
2232:
2207:
2194:New York Times
2179:
2140:
2122:
2097:
2072:
2069:on 2007-07-04.
2054:
2033:
2008:
1993:
1942:
1895:
1877:
1852:
1841:(2): 187–194.
1813:
1792:
1743:
1696:
1654:
1628:
1602:
1572:
1546:
1516:
1487:
1468:
1455:(5): 297–311.
1432:
1410:
1407:. 16 Feb 2007.
1395:
1367:
1348:
1322:
1302:
1276:
1271:Market Realist
1257:
1227:
1193:
1168:
1139:(4): 271–278.
1119:
1089:
1060:(2): 151–185.
1044:
1025:
971:
945:
923:
897:
871:
843:
818:
795:
788:35 U.S.C.
780:
755:
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703:
672:
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665:
664:
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654:
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644:
639:
634:
629:
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619:
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609:
602:
600:
597:
548:
545:
522:Main article:
519:
516:
491:Main article:
488:
485:
477:metoclopramide
472:
469:
436:
433:
415:
412:
362:immunogenicity
346:
343:
322:
313:parameters of
258:drug discovery
254:profit margins
206:
203:
188:
185:
139:European Union
26:
24:
14:
13:
10:
9:
6:
4:
3:
2:
3117:
3106:
3103:
3101:
3100:Public domain
3098:
3096:
3093:
3091:
3088:
3087:
3085:
3075:. 2 May 2018.
3074:
3070:
3060:on 2021-04-22
3059:
3055:
3053:
3047:
3043:
3039:
3035:
3031:
3027:
3017:on 2009-05-28
3016:
3012:
3011:
3006:
3002:
2998:
2994:
2993:
2989:
2982:
2976:
2973:. JHU Press.
2972:
2968:
2964:
2963:
2958:
2942:
2935:
2929:
2926:
2922:(in Chinese).
2921:
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2898:
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2607:
2601:
2598:
2587:
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2581:
2574:
2572:
2568:
2556:
2552:
2546:
2543:
2532:
2528:
2521:
2518:
2506:
2500:
2497:
2492:
2488:
2481:
2478:
2473:
2472:
2468:
2461:
2458:
2453:
2449:
2442:
2439:
2435:
2423:on 2009-10-20
2422:
2418:
2414:
2408:
2405:
2397:
2393:
2389:
2385:
2381:
2374:
2367:
2364:
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2355:
2351:
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2343:
2339:
2335:
2331:
2327:
2323:
2316:
2313:
2302:on 2016-08-03
2298:
2294:
2290:
2283:
2276:
2273:
2267:
2264:
2259:
2253:
2250:
2242:
2236:
2233:
2222:on 2017-05-16
2221:
2217:
2211:
2208:
2196:
2195:
2190:
2183:
2180:
2175:
2171:
2167:
2163:
2159:
2155:
2151:
2144:
2141:
2136:
2132:
2126:
2123:
2112:on 2018-03-19
2111:
2107:
2101:
2098:
2087:on 2007-10-16
2086:
2082:
2076:
2073:
2068:
2064:
2058:
2055:
2043:
2037:
2034:
2018:
2012:
2009:
2003:
1997:
1994:
1989:
1985:
1980:
1975:
1970:
1965:
1961:
1957:
1953:
1946:
1943:
1938:
1934:
1930:
1926:
1922:
1918:
1914:
1910:
1906:
1899:
1896:
1891:
1887:
1881:
1878:
1866:
1862:
1856:
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1848:
1844:
1840:
1836:
1829:
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1820:
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1814:
1802:
1796:
1793:
1788:
1784:
1779:
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1770:
1766:
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1754:
1747:
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1711:
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1700:
1697:
1692:
1685:
1681:
1677:
1673:
1669:
1665:
1658:
1655:
1643:on 2019-05-15
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