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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 , 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. Want to thank TFD for its existence? Tell a friend about us, add a link to this page, add the site to iGoogle, or visit the webmaster's page for free fun content. |
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No references found | In addition to the pharmaceutical composition patent that protects PROVIGIL until 2014, the drug has orphan drug exclusivity that prevents the approval of any ANDA for a modafinil product prior to June 2006, provided the FDA grants the company a six-month extension to the December 2005 orphan drug exclusivity upon completion of a pediatric study. The European Medicines Agency (EMEA) has granted Increlex([R]) orphan drug exclusivity for the treatment of severe Primary IGFD, providing a 10-year period of marketing exclusivity for the approved indication. Increlex was approved for severe Primary IGFD by the US Food and Drug Administration (FDA) on August 30, 2005, and has received orphan drug exclusivity in the US for this indication. |
Orphan drug exclusivity |
ORPCE ORPD ORPE Orpen, Sir William Orpen, William Newenham Montague ORPG Orphaline orphan orphan orphan orphan orphan Orphan Annie eye Orphan Annie Eyes Orphan Annie Face Orphan asylum Orphan asylum Orphan Care for Central Asia Orphan Data orphan disease orphan disease Orphan Disease Update Orphan diseases orphan drug orphan drug orphan drug orphan drug Orphan Drug Act Orphan Drug Act Orphan Drug Act Orphan drug exclusivity orphan drug/productOrphan drugs Orphan drugs orphan feeding orphan feeding Orphan Foundation of America orphan link orphan lot Orphan Medicinal Product Designation Orphan patient Orphan patients Orphan Pharma international Orphan process Orphan Product Orphan Product Orphan receptor Orphan receptor Orphan receptor Orphan receptor Orphan Receptor Response Element orphan site Orphan status Orphan status Orphan stock Orphan stock Orphan stock Orphan stock Orphan stock Orphan Stocks Orphan train | |||||||
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