Definitions for "Orphan drug"
Related Terms:
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A drug for a rare disease. The indications for which the product in question is intended are encountered so rarely that the applicant cannot reasonably be expected to provide comprehensive evidence
drugs developed for rare diseases and conditions which, in the U.S., affect fewer than 200,000 people or, in the European Union, affect 5 or fewer per 10,000 people. Because sales of orphan drugs are likely to be small compared to their development costs, pharmaceutical companies are awarded exclusive rights to market these medicines for a period of time as an incentive to develop them.
A drug that treats a rare disease.
A drug for a rare disease or condition for which the FDA can allow expedited review and provide certain competitor protection in order to reduce cost and provide financial incentives for development of such drugs.
The FDA grants Orphan Drug status to one company for a drug that is believed to substantially increase the life expectancy of the treated patient for a particular disease. This excludes other companies from receiving an FDA license to produce a similar drug for a finite period (usually 7 years), thereby allowing the company producing the drug to recuperate their R&D expenses.
a category created by US FDA for medications used to treat diseases that occur rarely (less than 200,000 cases) or that there is no hope for recovery of development costs, so there is little financial incentive for industry to develop them; orphan drug status gives the manufacturer financial incentives to provide the drug
a drug with only a limited target population (less than 200,000 in the US) or which treats a rare disease, usually in an area of unmet medical need. Such drugs are given regulatory designation to allow rapid progress through trials. While there is no reduction in the stringency of the safety requirements, the level of efficacy that must be shown may be reduced
Term referring to a product that treats a rare disease affecting fewer than 200,000 Americans. The Food and Drug Administration (FDA) provides this designation and incentives for companies making orphan drugs to stimulate the research, development, and approval of products that treat rare diseases.
a drug for the treatment of a rare disease for which reasonable recovery of the sponsoring firm's research and development expenditure is not expected within a reasonable time
a drug that has a very limited use
a medicinal product which has been identified by any doctor or dentists as an appropriate and essential remedy with no effective substitute for the treatment of any rare disease
a medicine developed for rare diseases and conditions which, in the U
A designation by the FDA or EMEA for certain drugs for rare diseases and conditions
FDA designation indicating a therapy developed to treat a rare disease (one that affects 200,000 people in the U.S.). Because manufacturers have little incentive to develop drugs for rare diseases, the government offers additional incentives (i.e. tax advantages and extended marketing exclusivity) for them to develop such drugs.
A drug whose development has been neglected due to limited profit potential, often because it treats a rare disease.
A designation of the FDA to indicate a therapy developed to treat a rare disease (one which afflicts a U.S. population of less than 200,000 people). Because there are few financial incentives for drug companies to develop therapies for diseases that afflict so few people, the U.S. government offers additional incentives to drug companies (i.e. tax advantages and extended marketing exclusivity) that develop these drugs.
An orphan drug is a medication that has received a special status from the FDA because it is designed to treat a very rare condition. The FDA established the orphan drug designation to reduce the cost of drug development for drugs needed by small numbers of patients.
a status granted by the FDA to unpatentable medications developed for rare diseases. Orphan drug status gives the drug's manufacturer a seven-year right to exclusively market the compound. This protection of unpatentable orphan drugs encourages their development by greatly increasing their profitability.
a drug that treats a disease that affects less than 200,000 Americans or for which there is no reasonable expectation that the cost of research and development will be recovered from sales in the United States. The Orphan Drug Act provides special incentives for producers of orphan drugs.
The Orphan Drug program provides incentives for companies to develop and market drugs for diseases for which the number of patients afflicted with the disease is very small.
The granting of the orphan drug status is designed to encourage the development of drugs which are necessary but would be prohibitively expensive/un-profitable to develop under normal circumstances.