Orphan drug

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orphan drug

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 ?
With Orphan Drug exclusivity and the recently announced victory in our Gralise patent litigation against Actavis blocking generic Gralise until 2024, we expect Gralise to benefit from nearly an additional decade of commercial exclusivity.
The FDA orphan drug exclusivity approval for wilate(R) confirms Octapharma's decision to focus exclusively on the treatment of von Willebrand patients and further demonstrates Octapharma's commitment to the continued advancement of human protein therapies," said Nielsen.
The FDA has granted Somatuline([R]) Depot orphan drug exclusivity for the treatment of acromegaly, providing a seven-year period of marketing exclusivity.
Though we and the FDA have different perspectives on the statute and regulations relevant to orphan drug exclusivity for Gralise, we very much appreciate the FDA's consideration of our views," commented James Schoeneck, Depomed's President and Chief Executive Officer.
This orphan drug exclusivity prevents the FDA from approving another application, including a full new drug application (NDA), to market the same drug for the same orphan indication, except in very limited circumstances.
Final FDA approval is contingent upon the expiration of Orphan Drug Exclusivity on December 12, 2002, resolution of the patent litigation that IMPAX has initiated against Aventis regarding a patent recently listed by Aventis in the FDA "Orange Book," as well as FDA's evaluation of any new information subsequent to this tentative approval.
Food and Drug Administration (FDA) has granted Octapharma orphan drug exclusivity for wilate (von Willebrand Factor/Factor VIII Concentrate, Human), the first replacement therapy developed specifically for von Willebrand Disease (VWD).
Biogen, however, is keeping Beneferon(TM) off the market through its Orphan Drug exclusivity for Avonex(TM).
The FDA has also previously granted orphan drug exclusivity for octaplex in this indication.
With this suit, Berlex seeks to protect the Orphan Drug exclusivity awarded to BETASERON(R) (interferon beta-1b) by the FDA in 1993.
By taking away orphan drug exclusivity, the FDA would be effectively gutting the incentive that Congress provided to encourage the development of safe and effective drugs for rare diseases.