Orphan drug

(redirected from Orphan drug exclusivity)
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orphan drug

[ôr′fən]
Etymology: Gk, orphanos, without parents; ME, drogge
a term that generally refers to drugs needed to treat rare diseases but can encompass any pharmaceutic product available to physicians and patients in countries other than the United States that has not been "adopted" by a domestic pharmaceutic manufacturer or distributor. An orphan drug may not be available in the United States because total sales would not justify the expense of research and development or because the medication may be a natural substance that cannot be effectively protected by patent laws against competition from a similar form of the product. The U.S. Orphan Drug Act of 1983 offers federal financial incentives to commercial and nonprofit organizations to develop and market drugs previously unavailable in the United States for rare diseases affecting fewer than 200,000 people. The FDA assists in the process with its office of Orphan Product Development.
Any drug, biological, medical device, or food of potential or actual use in treating ‘orphan’ diseases—diseases regarded by the pharmaceutical industry as too rare for developing commercially viable products

orphan drug/product

Any drug, biological, medical device, or food of potential or actual use in treating 'orphan' diseases–diseases regarded by the pharmaceutical industry as too rare for developing commercially viable products. See Orphan disease. Cf Pseudoorphan drug.

Orphan drug

A term for a drug that treats a rare disease, defined by the Food and Drug Administration (FDA) as one that affects fewer than 200,000 Americans. The FDA has an Office of Orphan Products Development (OOPD), which offers grants to researchers to develop these products.
References in periodicals archive ?
Although PHN qualifies as a "rare disease or condition," Neurontin never held orphan drug exclusivity nor has it been designated as an orphan drug.
TREANDA has orphan drug exclusivity for this indication through March 2015.
Biopharmaceutical company Raptor Pharmaceutical Corp (NasdaqGM:RPTP) reported on Monday the receipt of a positive opinion from the European Union (EU) Committee for Orphan Medicinal Products (COMP) recommending orphan drug exclusivity for PROCYSBI (mercaptamine) gastro-resistant hard capsules for the treatment of proven nephropathic cystinosis.
The FDA has granted Somatuline([R]) Depot orphan drug exclusivity for the treatment of acromegaly, providing a seven-year period of marketing exclusivity.
Biotechnology company Raptor Pharmaceutical Corp (NasdaqGM:RPTP) reported on Tuesday that it has received orphan drug exclusivity for PROCYSBI (cysteamine bitartrate) delayed-release capsules for the management of nephropathic cystinosis in patients age six and older.
Orphan drug designation provides incentives such as tax credits, user fee waivers and eligibility for orphan drug exclusivity to assist and encourage the development of drugs for rare diseases.
Orphan drug designation reportedly qualifies a company for several benefits under the Orphan Drug Act of 1983 (ODA), as amended, including a seven year period of orphan drug exclusivity upon product approval, a tax credit for certain clinical testing expenses for the orphan drug, written guidance on the non-clinical and clinical studies needed to obtain marketing approval of an orphan drug and orphan drug grants.
Food and Drug Administration (FDA) on August 30, 2005 and has received orphan drug exclusivity in the U.
Cotellic also received orphan drug designation, which provides incentives such as tax credits, user fee waivers and eligibility for orphan drug exclusivity to assist and encourage the development of drugs for rare diseases.
The FDA approval and granting of orphan drug exclusivity of wilate marks the entrance of Octapharma USA into the US blood coagulation market, with product availability scheduled for early 2010.
Approval followed the expiration of Aventis' Orphan Drug Exclusivity on December 12, 2002.