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Encyclopedia > Generic drug

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A generic drug (generic drugs, short: generics) is a drug which is produced and distributed without patent protection. (The generic drug may still have a patent on the formulation but not on the active ingredient.) A generic must contain the same active ingredients as the original formulation. In most cases, it is considered bioequivalent to the brand name counterpart with respect to pharmacokinetic and pharmacodynamic properties. By extension, therefore, generics are assumed to be identical in dose, strength, route of administration, safety, efficacy, and intended use. In most cases, generic products are not available until the patent protections afforded to the original developer have expired. When generic products become available, the market competition often leads to substantially lower prices for both the original brand name product and the generic forms. The time it takes a generic drug to appear on the market varies. Drug patents give twenty years of protection, but they are applied for before clinical trials begin, so the effective life of a drug patent tends to be between seven and twelve years. This article does not cite any references or sources. ... For other uses, see Patent (disambiguation). ... For other uses, see Patent (disambiguation). ... Bioequivalence is a term in pharmacokinetics used to assess the expected in vivo biological equivalence of two proprietary preparations of a drug. ... For other uses, see Brand (disambiguation). ... Pharmacokinetics (in Greek: pharmacon meaning drug, and kinetikos meaning putting in motion) is a branch of pharmacology dedicated to the determination of the fate of substances administered externally to a living organism. ... Pharmacodynamics is the study of the biochemical and physiological effects of drugs and the mechanisms of drug action and the relationship between drug concentration and effect. ... For other uses, see Patent (disambiguation). ...


Economics

Drug companies attempt to thwart cheaper, bioequivalent generic competition with direct-to-physician advertising that insinuates pharmacist substitution of a cheaper product is usurping physician′s authority. DAW is an acronym for Dispense As Written, ensuring that pharmacists fill a Valium prescription for brand-name Valium instead of equivalent and cheaper generic diazepam.
Drug companies attempt to thwart cheaper, bioequivalent generic competition with direct-to-physician advertising that insinuates pharmacist substitution of a cheaper product is usurping physician′s authority. DAW is an acronym for Dispense As Written, ensuring that pharmacists fill a Valium prescription for brand-name Valium instead of equivalent and cheaper generic diazepam.

The principal reason for the relatively low price of generic medicines is that competition increases among producers when drugs no longer are protected by patents. Companies also incur fewer costs in creating the generic drug, and are therefore able to maintain profitability while offering the drug at a lower cost to consumers. The costs of these generic drugs are so low that many developing countries can easily afford them. For example Thailand is going to import millions of pills of the generic version of Plavix, a blood-thinning treatment to prevent heart attacks, at a cost of 3 US cents per pill from India, the leading manufacturer of generic drugs.[citation needed] Image File history File links Size of this preview: 442 × 599 pixelsFull resolution (558 × 756 pixels, file size: 466 KB, MIME type: image/png) This is a copyrighted image that has been released by a company or organization to promote their work or product in the media, such as advertising... Image File history File links Size of this preview: 442 × 599 pixelsFull resolution (558 × 756 pixels, file size: 466 KB, MIME type: image/png) This is a copyrighted image that has been released by a company or organization to promote their work or product in the media, such as advertising... Overview A Digital Audio Workstation (DAW) is a system designed to record, edit, and play back digital audio. ... It has been suggested that this article or section be merged with Backronym and Apronym (Discuss) Acronyms and initialisms are abbreviations, such as NATO, laser, and ABC, written as the initial letter or letters of words, and pronounced on the basis of this abbreviated written form. ... Diazepam, brand names: Valium, Seduxen, in Europe Apozepam, is a 1,4-benzodiazepine derivative, which possesses anxiolytic, anticonvulsant, sedative and skeletal muscle relaxant properties. ... Look up Generic in Wiktionary, the free dictionary. ... Diazepam (IPA: ), first marketed as Valium by Hoffmann-La Roche) is a benzodiazepine derivative drug. ...


Generic manufacturers do not incur the cost of drug discovery, and instead are able to reverse-engineer known drug compounds to allow them to manufacture bioequivalent versions. Generic manufacturers also do not bear the burden of proving the safety and efficacy of the drugs through clinical trials, since these trials have already been conducted by the brand name company. In most countries, generic manufacturers must only prove that their preparation is bioequivalent to the existing drug in order to gain regulatory approval.[citation needed] It has been estimated that the average cost to brand-name drug companies of discovering and testing a new innovative drug (with a new chemical entity) may be as much as $800 million.[1] In medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are discovered and/or designed. ... Reverse engineering (RE) is the process of discovering the technological principles of a device or object or system through analysis of its structure, function and operation. ... Bioequivalence is a term in pharmacokinetics used to assess the expected in vivo biological equivalence of two proprietary preparations of a drug. ... ... Efficacy is the ability to produce a desired amount of a desired effect. ... This box:      In health care, a clinical trial is a comparison test of a medication or other medical treatment (such as a medical device), versus a placebo (inactive look-a-like), other medications or devices, or the standard medical treatment for a patients condition. ...


Generic drug companies may also receive the benefit of the previous marketing efforts of the brand-name drug company, including media advertising, presentations by drug representatives, and distribution of free samples. Many of the drugs introduced by generic manufacturers have already been on the market for a decade or more, and may already be well-known to patients and providers (although often under their branded name).


Prior to the expiration of a drug patent, a brand name company enjoys a period of “market exclusivity” or monopoly, in which the company is able to set the price of the drug at the level which maximizes profitability. This price often greatly exceeds the production costs of the drug, which can enable the drug company to make a significant profit on their investment in research and development. The advantage of generic drugs to consumers comes in the introduction of competition, which prevents any single company from dictating the overall market price of the drug. With multiple firms, the profit-maximizing price generally reflects the ongoing cost of producing the drug, which is usually much lower than the monopoly price. This article is about the economic term. ... Profitability is a technical analysis term used to compare performances of different trading systems or different investments within one system. ... Consumers refers to individuals or households that use goods and services generated within the economy. ... For other uses, see Competition (disambiguation). ...


Given that the US does not regulate drug prices, generic drugs are generally most expensive in the US, and cost the least in countries such as India and Thailand, where regulations favor consumers, not the drug companies.


Patent issues

When can a generic drug be produced?

When a pharmaceutical company first markets a drug, it is usually under a patent that allows only the pharmaceutical company that developed the drug to sell it. Generic drugs can be legally produced for drugs where: 1) the patent has expired, 2) the generic company certifies the brand company's patents are either invalid, unenforceable or will not be infringed, 3) for drugs which have never held patents, or 4) in countries where a patent(s) is/are not in force.[citation needed] The expiration of a patent removes the monopoly of the patent holder on drug sales licensing. Patent lifetime differs from country to country, and typically there is no way to renew a patent after it expires.[citation needed] A new version of the drug with significant changes to the compound could be patented, but this requires new clinical trials. In addition, a patent on a changed compound does not prevent sales of the generic versions of the original drug unless regulators take the original drug off the market. For other uses, see Patent (disambiguation). ... For other uses, see Patent (disambiguation). ...


This allows the company to recoup the cost of developing that particular drug. After the patent on a drug expires, any pharmaceutical company can manufacture and sell that drug. Since the drug has already been tested and approved, the cost of simply manufacturing the drug will be a fraction of the original cost of testing and developing that particular drug.


Challenging patents

Brand-name drug companies have used a number of strategies to extend the period of market exclusivity on their drugs, and prevent generic competition. This may involve aggressive litigation to preserve or extend patent protection on their medicines, a process referred to by critics as “evergreening”. Patents are typically issued on novel pharmacological compounds quite early in the drug development process, at which time the ‘clock’ to patent expiration begins ticking. Later in the process, drug companies may seek new patents on the production of specific forms of these compounds, such as single enantiomers of drugs which can exist in both “left-handed” and “right-handed” forms,[2] different inactive components in a drug salt,[3] or a specific hydrate form of the drug salt.[4] If granted, these patents ‘reset the clock’ on patent expiration. These sorts of patents may later be targeted for invalidation (“paragraph IV certification”)[5] by generic drug manufacturers.[6][7][8] Drug development or preclinical development is defined in many pharmaceutical companies as the process of taking a new chemical lead through the stages necessary to allow it to be tested in human clinical trials, although a broader definition would encompass the entire process of drug discovery and clinical testing of... In chemistry, enantiomers (from the Greek ἐνάντιος, opposite, and μέρος, part or portion) are stereoisomers that are nonsuperimposable complete mirror images of each other, much as ones left and right hands are the same but opposite. ... This article is about the term salt as referred to in chemistry. ... Hydrate is a term which means different things in inorganic chemistry and organic chemistry. ...


Generic drug exclusivity

The U.S. Food and Drug Administration offers a 180 day exclusivity period to generic drug manufacturers in specific cases.[9] During this period only one (or sometimes a few) generic manufacturers can produce the generic version of a drug. This exclusivity period is only used when a generic manufacturer argues that a patent is invalid or is not violated in the generic production of a drug, and the period acts as a reward for the generic manufacturer who is willing to risk liability in court and the cost of patent court litigation. There is often contention around these 180 day exclusivity periods because a generic producer does not have to produce the drug during this period and can file an application first to prevent other generic producers from selling the drug. FDA redirects here. ...


Large pharmaceutical companies often spend thousands of dollars protecting their patents from generic competition.[citation needed] Apart from litigation, companies use other methods such as reformulation or licensing a subsidiary (or another company) to sell generics under the original patent. Generics sold under license from the patent holder are known as authorized generics;[10] they are not affected by the 180 day exclusivity period as they fall under the patent holder′s original drug application.


A prime example of how this works[11] is simvastatin (Zocor), a popular drug created and manufactured by U.S. based pharmaceutical Merck & Co., which lost its US patent protection on June 23, 2006. India-based Ranbaxy Laboratories (at the 80 mg strength) and Israel-based Teva Pharmaceutical Industries (at all other strengths) received 180 day exclusivity periods for simvastatin; due to Zocor′s popularity, both companies began marketing their products immediately after the patent expired. However, Dr. Reddy′s Laboratories also markets an authorized generic version of simvastatin under license from Zocor′s manufacturer, Merck & Co.; some packages of Dr. Reddy′s simvastatin even show Merck as the actual manufacturer and have Merck′s logo on the bottom. Simvastatin (INN) (IPA: ) is a hypolipidemic drug belonging to the class of pharmaceuticals called statins. It is used to control hypercholesterolemia (elevated cholesterol levels) and to prevent cardiovascular disease. ... Merck & Co. ... Ranbaxy Laboratories Limited is an Indian company incorporated in 1961. ... Teva Pharmaceutical Industries Ltd. ... Dr. Reddy’s Laboratories Ltd. ...


Approval and regulation

Ensuring bioequivalence

Most nations require generic drug manufacturers to prove that their formulation exhibits bioequivalence to the innovator product.[12][13][14][15][16][17][18] Over the past several years there have been studies that have shown the effectiveness and safety of some generic drugs.[citation needed] Generic drugs are always less expensive and can save patients and insurance companies thousands of dollars supposedly without compromising the quality of care. The FDA must approve generic drugs just as innovator drugs must be approved.[citation needed] Bioequivalence, however, does not mean that generic drugs must be exactly the same (“pharmaceutical equivalent”) as their innovator product counterparts, as chemical differences may exist (different salt or ester – a “pharmaceutical alternative”). Some doctors and patients emphatically believe that certain generic drugs are not as effective as the products they are meant to replace (i.e., Prozac, Oxycontin)[citation needed], and consumers would undoubtedly benefit from more clinical studies done on drug by drug basis. Further complicating the problem is a gap in prescribing doctors' understanding bioequivalence standards, as a physician survey in the US found that only 17% of prescribing physicians correctly identified the USFDA's standards for bioequivalency of generic drugs. [8] A latest development to address the issue enables interested doctors and consumers to check generic drug interactions and outcomes detail to the specific drug and drug company. [19] Bioequivalence is a term in pharmacokinetics used to assess the expected in vivo biological equivalence of two proprietary preparations of a drug. ... This article is about the term salt as referred to in chemistry. ... For other uses, see Ester (disambiguation). ...


Generic drugs start out at first being fairly expensive; however, the price of the generic product decreases as the rate of production increases.


As an interesting case study in the use of generic equivalents of name-brand agents, warfarin has been only available under the trade name Coumadin in North America until recently. Warfarin (either under the trade name or the generic equivalent) has a narrow therapeutic window and requires frequent blood tests to make sure patients do not have a subtherapeutic or a toxic level. A study performed in the Canadian province of Ontario showed that replacing Coumadin with generic warfarin was considered safe.[20] In spite of the study, many physicians are not comfortable in allowing their patients to take the branded generic equivalent agents.[21] Warfarin (also known under the brand names of Coumadin, Jantoven, Marevan, and Waran) is an anticoagulant medication that is administered orally or, very rarely, by injection. ... Warfarin (also known under the brand name Coumadin®) is an anticoagulant medication that can be administered orally. ... This article is about the Canadian province. ...


U.S. generics approval process enacted in 1984, the U.S. Drug Price Competition and Patent Term Restoration Act, informally known as the “Hatch-Waxman Act”, standardized U.S. procedures for recognition of generic drugs. An applicant files an Abbreviated New Drug Application (or “ANDA”) with the Food and Drug Administration (FDA) and seeks to demonstrate therapeutic equivalence to a specified, previously approved “reference listed drug”. When an ANDA is approved, the FDA adds the drug to its Approved Drug Products list, also known as the “Orange Book”, and annotates the list to show equivalence between the reference listed drug and the approved generic. The FDA also recognizes drugs using the same ingredients with different bioavailability and divides them into therapeutic equivalence groups. For example, as of 2006 diltiazem hydrochloride had four equivalence groups all using the same active ingredient but considered equivalent only within a group.[22] The Drug Price Competition and Patent Term Restoration Act, informally known as the Hatch-Waxman Act [Public Law 98-417], is a 1984 United States federal law which established the modern system of generic drugs. ... FDA redirects here. ...


On October 4, 2007, FDA launched the Generic Initiative for Value and Efficiency, or GIVE.[23] The initiative will use existing resources to help FDA modernize and streamline the generic drug approval process.


GIVE aims to increase the number and variety of generic drug products available. Having more generic-drug options means more cost-savings to consumers, as generic drugs cost about 30 percent to 80 percent less than brand name drugs.


Generic drugs are identical to their brand-name counterparts in dosage form, safety, strength, route of administration, quality, performance, and intended use. Generics also go through a rigorous scientific review to ensure both safety and effectiveness.


In the United States, generic drug substances are named through review and recommendation of the United States Adopted Names (USAN) Council.


See also

Anda is the name of two places in the Philippines: Anda, Bohol Anda, Pangasinan Anda is a location in Afghanistan Anda is a small island in Norway, home to the Anda lighthouse. ... Clinical monitoring - Oversight and administrative efforts that monitor a participants health during a clinical trial. ... This article needs to be cleaned up to conform to a higher standard of quality. ... Using the knowledge gained in basic and applied research to conduct research (generally with humans) in treating disease or dysfunction in a new way. ... This article needs to be cleaned up to conform to a higher standard of quality. ... Generic brands of consumer products (often supermarket goods) are distinguished by the absence of a brand name. ... In patent law, the research exemption or safe harbour exemption is an exemption to the rights conferred by patents, which is especially relevant to drugs. ...

References

  1. ^ “The price of innovation: new estimates of drug development cost” (pdf) DiMasi J.A. et al.: , Journal of Health Economics 22(2003), 151-185. Retrieved on 2008-06-16
  2. ^ [1] U.S. Patent 4,721,723: Dextro-rotatory enantiomer of methyl alpha-5 (4,5,6,7-tetrahydro (3,2-c) thieno pyridyl) (2-chlorophenyl)-acetate
  3. ^ [2] U.S. Patent 4,879,303: Amlodipine besylate
  4. ^ [3] U.S. Patent 4,721,723: Paroxetine hydrochloride hemihydrate
  5. ^ Paragraph IV Drug Product Applications: Generic Drug Patent Challenge Notifications. FDA, Office of Generic Drugs (OGD) (2008-06-11). Retrieved on 2008-06-16.
  6. ^ [4] Brisol-Myers Squibb press release on successful defense of Plavix patent
  7. ^ [5] Apotex press release on successful challenge of Norvasc patent
  8. ^ [6] Apotex press release on successful challenge of Paxil patent
  9. ^ Guidance for Industry: 180-Day Generic Drug Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act. FDA, Center for Drug Evaluation and Research (CDER) (June 1998). Retrieved on 2008-06-21.
  10. ^ Authorized Generics. Generic Pharmaceutical Association (GPhA) (2008). Retrieved on 2008-06-16.
  11. ^ Teva, Ranbaxy May Have Windfall With Generic Zocor. Bloomberg.com (May 1, 2006). Retrieved on 2008-06-16.
  12. ^ WHO Technical Report Series No. 937: Annex 7 (pdf) 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, May 2006. Accessed 2008-06-15
  13. ^ Food and Drug Administration, Department of Health and Human Services: Code of Federal Regulations 320 Title 21, Volume 5, Revised as of April 1, 2008 CFR 320 21/5, Revised as of April 1, 2008. Accessed 2008-06-15
  14. ^ Health Canada, Drugs and Health Products, Bioavailability and Bioequivalence Health Canada, Guidance Documents. Accessed 2008-06-15
  15. ^ EudraLex – The Rules Governing Medicinal Products in the European Union EudraLex. Accessed 2008-06-15
  16. ^ European Medicines Agency EMEA. Accessed 2008-06-15
  17. ^ EudraLex – The Rules Governing Medicinal Products in the European Union EudraLex. Accessed 2008-06-15
  18. ^ Japan, National Institute for Health Sciences, Division of Drugs Guidances Japan, NIHS, Division of Drugs. Accessed 2008-06-15
  19. ^ [7] - Generic drug interaction checker and monitor
  20. ^ Pereira JA, Holbrook AM, Dolovich L, Goldsmith C, Thabane L, Douketis JD, Crowther MA, Bates SM, Ginsberg JS. (2005). "Are brand-name and generic warfarin interchangeable? Multiple n-of-1 randomized, crossover trials.". Ann Pharmacother 39 (7-8): 1188–93. doi:10.1345/aph.1G003. PMID 15914517. 
  21. ^ Pereira JA, Holbrook AM, Dolovich L, Goldsmith C, Thabane L, Douketis JD, Crowther M, Bates SM, Ginsberg JS. (2005). "Are brand-name and generic warfarin interchangeable? A survey of Ontario patients and physicians.". Can J Clin Pharmacol 12 (3): e229–39. PMID 16278495. 
  22. ^ Approved Drug Products with Therapeutic Equivalence Evaluations, Preface. - an explanation of FDA terms and procedures
  23. ^ Generic Initiative for Value and Efficiency (GIVE). FDA (October 4, 2007). Retrieved on 2008-06-15.

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External links


  Results from FactBites:
 
Generic Drug Information from Drugs.com (596 words)
A generic drug is a drug that is exactly the same as the brand-name drug, but can only be produced after the brand-name drug's patent has expired.
Although generic drugs are chemically identical to their branded counterparts, they are typically sold at a cheaper price than the brand-name drug because the drug has not been developed from scratch, and the costs to bring the drug to market are less.
New drugs are developed under patent protection, and most drug patents are protected for 17 years giving the drug company the sole right to sell the brand-name drug during that time.
Nasdaq 100 Flash Quotes (490 words)
It is understood that the company has inked an agreement with the innovator company to launch the drug next year in the US with 180-day marketing exclusivity, as it is the first company to challenge the patent of the drug.
However, analysts feel that the Indian drug maker could generate revenue of around $2 billion from the US market from the four drugs alone, provided all goes well, while others say that the exact upside the company will get from such settlements could not be measured.
Ranbaxy aims to be the amongst the top five global generic company and plans to achieve global sales of $5 billion by 2012, without taking into account the sales from few of high revenue drugs.
  More results at FactBites »

 
 

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