orphan drug

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orphan drug,

drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the development and manufacturing of such drugs, which otherwise might not be profitable because of the small potential market. (Of the 5,000 diseases covered under the act, 47% affect fewer than 25,000 people.) The law has led to the introduction of valuable new drugs for the treatment of rare diseases, but some drug companies have been accused of abusing the law's provisions by making inordinately high profits on orphan drugs under monopoly. Since the 1983 act went into effect, many orphan drugs have been approved, including those for the treatment of such conditions as AIDSAIDS
or acquired immunodeficiency syndrome,
fatal disease caused by a rapidly mutating retrovirus that attacks the immune system and leaves the victim vulnerable to infections, malignancies, and neurological disorders. It was first recognized as a disease in 1981.
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, cystic fibrosiscystic fibrosis
, inherited disorder of the exocrine glands (see gland), affecting children and young people; median survival is 25 years in females and 30 years in males.
..... Click the link for more information.
, blepharospasm (uncontrolled rapid blinking), and snake bite.

orphan drug

[¦ȯr·fən ′drəg]
(pharmacology)
A pharmaceutical developed to treat a disease that afflicts relatively few people.
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References in periodicals archive ?
The court's ruling requires that the FDA grant Orphan Drug exclusivity for Gralise for the management of PHN.
In awarding orphan drug exclusivity, the FDA Office determined that wilate(R) offers greater viral safety than Humate-P," said Flemming Nielsen, President of Octapharma USA, the rapidly growing U.
The FDA orphan drug exclusivity approval for wilate(R) is an important aspect in Octapharma's development of this drug," said Kim Bjornstrup, Vice Chairman, Octapharma Group.
Food and Drug Administration (FDA) has granted orphan drug exclusivity for TREANDA all through October 2015 for indolent B-cell non-Hodgkin lymphoma (iNHL) that has advanced during or within six months of treatment with rituximab or a rituximab-containing regimen.
The European Medicines Agency (EMEA) has granted Increlex([R]) orphan drug exclusivity for the treatment of severe Primary IGFD, providing a 10-year period of marketing exclusivity for the approved indication.
The FDA has not granted orphan drug exclusivity to Gralise, even though the product was approved for its orphan-designated use.
Increlex was approved for severe Primary IGFD by the US Food and Drug Administration (FDA) on August 30, 2005, and has received orphan drug exclusivity in the US for this indication.
Octapharma's wilate[R](Von Willebrand Factor/Coagulation Factor VIII Complex[human]) received orphan drug exclusivity from the U.
Food and Drug Administration (FDA) on August 30, 2005 and has received orphan drug exclusivity in the U.
Food and Drug Administration (FDA) granted Octapharma orphan drug exclusivity for wilate, the first replacement therapy developed specifically for VWD.
Approval followed the expiration of Aventis' Orphan Drug Exclusivity on December 12, 2002.