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.
..... Click the link for more information.
, 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.
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orphan drug

[¦ȯr·fən ′drəg]
(pharmacology)
A pharmaceutical developed to treat a disease that afflicts relatively few people.
McGraw-Hill Dictionary of Scientific & Technical Terms, 6E, Copyright © 2003 by The McGraw-Hill Companies, Inc.
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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.
Having earned orphan drug exclusivity for Qualaquin for the treatment of malaria, URL/Mutual is looking ahead at market exclusivity for this product until August 2012.
The positive opinion from the EMA's COMP has been sent to the European Commission, which is expected to grant the orphan drug designation within 30 days.Obtaining OMPD for naxitamab is part of an overall plan to expand the company's European development program and ultimately obtain orphan drug exclusivity to protect naxitamab in the EU for the treatment of relapsed or refractory high-risk neuroblastoma.
Furthermore, as a result of a Court decision, Bendeka now has orphan drug exclusivity (ODE) and the US FDA will not be able to approve any drug applications referencing Bendeka until the ODE expires in December 2022.
The company said the ODD can provide drug developers with up to seven years of Orphan Drug Exclusivity (ODE), extend the effective life of a commercial product, provides opportunities for grant funding, protocol assistance and financial benefits, a waiver of New Drug Application fees as well as tax credits.
Lumara Health markets Makena (hydroxyprogesterone caproate injection), which was granted seven-year orphan drug exclusivity in February 2011, and is an FDA approved product to reduce the risk of preterm birth (less than 37 weeks of pregnancy) in women who are pregnant with one baby and who have delivered a preterm baby spontaneously in the past.
Eagle Pharmaceuticals announced that the FDA has granted seven years of orphan drug exclusivity, or ODE, in the U.S., for Bendeka, a liquid, low-volume and short-time 10-minute infusion formulation of bendamustine hydrochloride.
(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.
Food and Drug Administration Office of Orphan Drug Products has recognized by letter to the company the seven-years of orphan drug exclusivity for GOCOVRI extended release capsules, the first and only FDA-approved medicine for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications.