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 ?
Until Depomed, orphan drug exclusivity was automatic when the statutory criteria were met and if the FDA had not already approved and designated an orphan drug for the same use or indication.
NYSE:TEVA) announced on Wednesday the grant of orphan drug exclusivity for TREANDA by the US Food and Drug Administration (FDA) through October 2015 for indolent B-cell non-Hodgkin lymphoma (iNHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.
The Orphan Drug Report 2011 profiles pharmaceutical drugs with FDA Orphan Drug Exclusivity granted by the FDA.
Orphan drug designationprovides incentives such as tax credits, user fee waivers and eligibility for orphan drug exclusivity to assist and encourage the development of drugs for rare diseases.
M2 EQUITYBITES-July 23, 2013-Raptor Pharmaceutical Corp receives EMA's positive opinion for orphan drug exclusivity for nephropathic cystinosis drug, PROCYSBI(C)2013 M2 COMMUNICATIONS http://www.
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.
6 Because orphan exclusivity applies to products approved under both the FDCA and the PHSA, any pending orphan drug exclusivity would be unaffected by this transition.
M2 PHARMA-July 23, 2013-Raptor Pharmaceutical Corp receives EMA's positive opinion for orphan drug exclusivity for nephropathic cystinosis drug, PROCYSBI(C)2013 M2 COMMUNICATIONS
M2 EQUITYBITES-June 26, 2013-Raptor Pharmaceutical Corp awarded US orphan drug exclusivity for PROCYSBI for nephropathic cystinosis(C)2013 M2 COMMUNICATIONS http://www.
M2 PHARMA-June 26, 2013-Raptor Pharmaceutical Corp awarded US orphan drug exclusivity for PROCYSBI for nephropathic cystinosis(C)2013 M2 COMMUNICATIONS
The US Food and Drug Administration's (FDA) orphan drug designation qualifies the company for several benefits, including a seven year period of orphan drug exclusivity upon product approval, a tax credit for certain clinical testing expenses for the orphan drug, written guidance on the non-clinical and clinical studies needed to obtain marketing approval of an orphan drug and orphan drug grants.
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.