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 ?
She is considered the primary American consumer advocate responsible for the passage of the Orphan Drug Act of 1983.
--No mes de dezembro, com a participacao da EURORDIS, e divulgado o Orphan Drug Act, para a Europa, que define como um dos criterios objetivos o uso da prevalencia para doencas raras de 5 para cada 10000 nascidos e vinculam diretamente as doencas raras aos medicamentos orfaos.
Regulatory policy, value of knowledge assets and innovation strategy: The case of the Orphan Drug Act. Research Policy (37: 2008)
Two additional sections are included on the latest developments, with profiles of the generic name and trade name of drugs and their sponsor with regard to the Orphan Drug Act, as well as current research on AIDS drugs under investigation.
In Congress, he has supported landmark health legislation such as the Ryan White Comprehensive AIDS Resources Emergency Act, the Nutrition Labeling and Education Act, the Breast and Cervical Cancer Mortality Prevention Act, the Safe Medical Devices Act, the Patent Term Restoration and Drug Competition Act and the Orphan Drug Act.
Orphan Drug Act, there are incentives for companies like Chelsea to bring desperately needed drug therapies like Droxidopa to underserved patients who suffer from neurogenic orthostatic hypotension," said Dr.
Growth Hormone first synthesized in 1985 under the Reagan Orphan drug act, to treat dwarfism, was quickly recognized to stop aging in its tracks and reverse it to a remarkable degree.
"In the Orphan Drug Act, which was passed in 1983 to encourage research on rare disorders, the federal government defined a rare disorder as one that afflicts fewer than 200,000 people," said Abbey Meyers, president of the National Organization for Rare Disorders Inc.
market under the provisions of the Orphan Drug Act. This law provides incentives for pharmaceutical companies to research and develop medications for conditions that affect a limited number of people.
The pediatric exclusivity provisions of the FDAMA are modeled on similar provisions established in the 1983 Orphan Drug Act. That act was intended to provide an incentive for pharmaceutical companies to develop drugs for rare diseases.
DeFelice's hopes for the Neutraceutical Research and Development Act (NREA) are based on the success of the Orphan Drug Act, which provides incentives to the manufacturers of drugs for rare diseases.