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.
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, 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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The report is a study on the global orphan drugs market along with an in-depth analysis of Asian, North-American, European and other regional markets.
Recognize potential: 39 companies reviewed to obtain the market size for orphan drugs.
a product can be designated an orphan drug if it is meant to treat an illness that affects fewer than 200,000 people.
Global Orphan Drug Market Future Outlook 2020" report highlights: - Global Orphan Drug Market Overview - Global Orphan Drug Market Segment Analysis - FDA & EMA Regulation for Clinical Trials Orphan Designated Drugs - Orphan Drug Designation Criteria & Reimbursement Policy by Region - Comprehensive Insight on Global Orphan Drugs Clinical Pipeline & Patent Analysis by Company, Country, Indication & Phase - Global Orphan Drugs Clinical Pipeline: 697 Drugs - Majority Orphan Drugs in Phase-II Trials: 249 Drugs - Marketed Orphan Drugs: 274 Drugs Key Topics Covered: 1.
The orphan drug and balloon technologies discussed here illustrate the significant impact that very expensive, very low volume technologies and high volume, "cost saving" technologies might have on an individual plan.
The OrphanDrugs Partnering Terms and Agreements report provides an understanding and access to the orphan drugs partnering deals and agreements entered into by the worlds leading healthcare companies.
com/research/t9qncf/global_orphan) has announced the addition of the "Global Orphan Drug Pipeline & Regulatory Insight 2015" report to their offering.
In 1985, inspired by the fact that, within two years of passage of the Orphan Drug Act, 54 orphan drugs were under development or already approved, Congress decided to extend the Act's authorization of research grants and expand its protection of marketing rights to all orphan drugs rather than just unpatentable ones.
A comprehensive overview of orphan drugs and their strategic importance is provided in this valuable new report
Food and Drug Administration (FDA) has granted the company Orphan Drug designation for Saposin C, active ingredient in its proprietary drug BXQ-350 for the potential treatment of glioblastoma multiforme.
The orphan drugs enjoy significant competitive advantages owing to the market exclusivity period after the drug has been authorized.
com/research/0944f17e/orphan_drugs_in_as) has announced the addition of the "Orphan Drugs in Asia: Guidelines and Regulatory Requirements to Help Orphan Drug Products Enter the Asian Market 2012" report to their offering.