Orphan drug

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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 ?
Groft, who heads the National Institutes of Health's Office of Rare Diseases, said, "The Orphan Drug Act led to the development of 260 products, which have been approved by the U.
Some observers have claimed that the Orphan Drug Act has stimulated much greater production of drugs to treat rare diseases.
Rare diseases activists, primarily led by NORD, fought to change this, and in 1983 the Orphan Drug Act became law.
The Orphan Drug Act addresses some of these issues; the U.
Orphan Drug designation qualifies the sponsor of the drug for various development incentives of the Orphan Drug Act, including tax credits for qualified clinical testing.
Medical food products are regulated by the Food and Drug Administration under the Orphan Drug Act.
In the decade before the Orphan Drug Act was signed into law during the Reagan administration, only 10 treatments had been developed for rare diseases by the pharmaceutical industry.
The Orphan Drug Act provides for incentives to encourage the development of drugs for rare disease conditions affecting fewer than 200,000 people in the United States.
The Orphan Drug Act provides a seven year period of exclusive marketing to the first sponsor who obtains approval for a designated product for the designated indication.
Two additional selections are included on the latest developments, with profiles of the generic name and trade name of drugs and their sponsor with regard to the Orphan Drug Act, as well as current research on AIDS drugs under investigation.
Avonex is protected from competition by "me-too" medications until 2003 under the federal Orphan Drug Act.
In 1983, Congress passed the Orphan Drug Act to encourage development of pharmaceuticals used in the treatment or diagnosis of diseases that occur so rarely that there is no financial incentive for development of these so-called "orphan drugs.