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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 AIDS AIDS 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. ..... Click the link for more information. , cystic fibrosis cystic fibrosis (sĭs`tĭk fībrō`sĭs) ..... 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. How to thank TFD for its existence? Tell a friend about us, add a link to this page, add the site to iGoogle, or visit webmaster's page for free fun content. |
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Orphan Drugs and Vaccines Situation in the United States It has been a strategy of pharmaceutical and biotechnology firms to have their compounds designated as orphan drugs under the provisions of the 1983 Orphan Drug Act, which provide government credit for R&D expenses for an orphan drug and marketing exclusivity for seven years. Developers of orphan drugs are granted seven years of marketing exclusivity after approval of their orphan drug product as well as tax incentives for clinical research they have undertaken. |
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