orphan drug

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Related to Orphan drugs: orphan disease

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 ?
According to a report recently released by the Pharmaceutical Manufacturers Association, in cooperation with the Food and Drug Administration's Office of Orphan Products Development and the National Organization for Rare Disorders, 133 orphan drugs that combat 96 rare diseases are currently being developed.
Groundwork Laid for Orphan Drug Success Industry experts estimate that orphan drugs bring in about $40 billion in annual sales.
Industry has responded to this call for action and the FDA has approved over 270 orphan drugs in the US whilst there are another 583 listed in the Medtrack database as being in ongoing development.
This report reviews the orphan drug regulations throughout Asia and discusses various business issues related to orphan drugs in Asia.
Asia-Pacific contains nearly two-thirds of the worlds population, and should offer great potential to companies developing orphan drugs.
Fully updated for 2009, with complete lists of orphan drugs approved in Japan and Korea.
Food and Drug Administration (FDA) has granted orphan drug designation to the company's drug candidate INNO-406, an orally bioavailable dual Bcr-Abl and Lyn-kinase inhibitor for Gleevec[R]-resistant or intolerant chronic myelogenous leukemia.
Food and Drug Administration has granted orphan drug designation for Ropidoxuridine (IPdR) for the treatment of malignant glioma, which makes up approximately half of all primary brain tumors.
com/reports/c31529) has announced the addition of Orphan Drugs Pipeline Analysis: Wider Incentives Encourage Orphan Drug R&D to their offering.