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.
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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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References in periodicals archive ?
Since Congress passed the Orphan Drug Act of 1983, the FDA has awarded more than 1,000 designations and approved more than 200 products.
Some observers have claimed that the Orphan Drug Act has stimulated much greater production of drugs to treat rare diseases.
With respect to the Orphan Drug Act, "our primary effort has been to keep it safe .
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.
Congress passed the Orphan Drug Act of 1983 to stimulate the development of medicines for rare diseases.
The Orphan Drug Act (ODA) in the USA provides the sponsor of the drug with various incentives to continue developing the drug, including tax credits for qualified clinical testing, a waiver of the marketing application and a period of market exclusivity.
The Orphan Drug Act (ODA) provides for granting special status to a product to treat a rare disease or condition upon request of a sponsor and if the disease or condition for which the drug is intended affects fewer than 200,000 people in the United States.
The Orphan Drug Act provides a 7-year period of exclusive marketing for the drug to the first sponsor who obtains marketing approval of the designated orphan drug.
Orphan drug products have seven years of marketing exclusivity for the designated indications once they receive FDA regulatory approval, according to the Orphan Drug Act of 1983.
The FDA reviewed these data and ruled that the benefits of Rebif are not sufficiently different to warrant ending market protections given to Avonex under the Orphan Drug Act.
We worked for passage of the Orphan Drug Act in 1983, and we continue to monitor the law to ensure that it lives up to its promise of promoting new treatments and cures for rare disorders.
Following the example of the US FDA's Orphan Drug Act established in 1983, some Asian countries have developed orphan drug legislations, such as Singapore's Orphan Drug Exemption to the Medicines Act and Japan's Orphan Drug Amendment to the Pharmaceutical Affairs Law.