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 ?
Seven-year marketing exclusivity to sponsors of approved orphan products.
The potential end-users of an orphan product may not be aware of therapeutic or preventive options.
Since its creation in 1983, the Orphan Products Clinical Trials Grants Program has provided more than $370 million to fund more than 590 new clinical studies and supported the marketing approval of more than 55 products.
The FDA awards the grants through the Orphan Products Grants Program to encourage clinical development of drugs, biologics, medical devices, or medical foods for use in rare diseases.
The US Food and Drug Administration (FDA) Office of Orphan Product Development has granted orphan drug designation to Amplyx Pharmaceuticals' lead drug candidate APX001 to treat multiple invasive fungal and mould infections, it was announced yesterday.
If a product that has orphan drug designation subsequently receives the first FDA approval for the disease for which it has such designation, the product is entitled to orphan product exclusivity for seven years.
It also received priority review and orphan product designation.
Biopharmaceutical company Anavex Life Sciences Corp (NasdaqCM:AVXL) reported on Friday that it has been granted orphan drug designation (ODD) for ANAVEX 2-73 for the treatment of Rett syndrome from the US Food and Drug Administration's (FDA) Office of Orphan Product Development (OOPD).