Orphan drug

(redirected from Orphan drug exclusivity)
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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.
Eagle continues to pursue obtaining a grant of Orphan Drug Exclusivity which would provide Bendeka exclusivity through December 2022.
M2 EQUITYBITES-July 23, 2013-Raptor Pharmaceutical Corp receives EMA's positive opinion for orphan drug exclusivity for nephropathic cystinosis drug, PROCYSBI(C)2013 M2 COMMUNICATIONS http://www.m2.com
M2 EQUITYBITES-June 26, 2013-Raptor Pharmaceutical Corp awarded US orphan drug exclusivity for PROCYSBI for nephropathic cystinosis(C)2013 M2 COMMUNICATIONS http://www.m2.com
The US Food and Drug Administration's (FDA) orphan drug designation qualifies the company for several benefits, 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.
M2 PHARMA-July 23, 2013-Raptor Pharmaceutical Corp receives EMA's positive opinion for orphan drug exclusivity for nephropathic cystinosis drug, PROCYSBI(C)2013 M2 COMMUNICATIONS
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.
M2 PHARMA-June 26, 2013-Raptor Pharmaceutical Corp awarded US orphan drug exclusivity for PROCYSBI for nephropathic cystinosis(C)2013 M2 COMMUNICATIONS