Orphan drug

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Related to Orphan status: Orphan Drug Act

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 ?
The rule states that should rights holders turn up to claim authorship or ownership of a previously-declared orphan work, the orphan status ends, and there must be 'fair compensation' for the use that has been made.
Orphan status is measured at the binary level with those who had lost both or either of their parents constituting one category and those who had both parents alive constituting another category.
A work given orphan status in one member state will be recognised as such throughout the EU.
Maybe, maybe not--but it is disappointing that we still fall out over fundamental definitions, especially as a century ago, the criteria for orphan status marked disputes about the benefits of emigration documented in Roy Parker's book (also reviewed in
In October 2004, the drug is granted for an orphan status by EC for adjunctive treatment of LGS, a severe form of epilepsy that develops in early childhood.
SciTech21-21 November 2006-FDA Grants Orphan Status to Synthetic Secretin from Repligen for Use with MRIs(C)2006 JeraOne - http://www.
As evidence, they point to the hundreds of drugs that have been granted orphan status and received FDA approval.
In addition, updated epidemiologic information from experts in the field of emerging diseases; increased disease awareness among health professionals, patients, and the general public; a list of priority vaccines; emergence of a dedicated organization with strong leadership; and the long-term pharmacoeconomic viability of orphan products will be key factors in overcoming the complexity of orphan status and the limited need for vaccine.
Orphan status provides incentives for companies to develop products for use in conditions that afflict fewer than 200,000 people.
The US Orphan Drug Designation program provides orphan status to drugs intended to treat rare diseases or disorders that affect fewer than 200,000 people in the US.
The US FDA's Orphan Drug Program provides orphan status to drugs and biologics that are intended for the treatment of rare diseases affecting fewer than 200,000 people in the United States.
Food and Drug Administration (FDA) previously granted the company's request for a Fast Track designation and orphan status for its H.