orphan drugs


Also found in: Dictionary, Encyclopedia.
Related to orphan drugs: orphan disease

or·phan pro·ducts

drugs, biologicals, and medical devices (including diagnostic in vitro tests) that may be useful in either common or rare diseases but that are not considered commercially viable.
Synonym(s): orphan drugs

or·phan prod·ucts

(ōr'făn prod'ŭkts)
Drugs, biologicals, and medical devices (including diagnostic in vitro tests) that may be useful in treating rare diseases but are not considered commercially viable.

orphan drugs

A drug used to treat a rare disease and for which the market is so small that manufacturers have little incentive to go to the expense of producing them. In1983 US legislation provided financial incentives, in the form of tax credits and 7 year exclusive rights, to firms willing to produce such drugs. This has been effective and, by mid-2003, 229 orphan drugs were available.
References in periodicals archive ?
Some 36 orphan drugs have been approved by the FDA under the Orphan Drug Act and are available to patients.
Prescription Orphan Drug and Biologic Developers and Marketers
Orphan drugs present opportunities to pharma companies looking to move into more niche indications and away from mass market indications that have very low levels of clinical unmet need.
Fully updated for 2010, with complete lists of orphan drugs approved in the US, Japan and Korea.
The main emphasis though is not on registration but on market access, which for products like orphan drugs that often carry premium prices, means eligibility for reimbursement or other sources of public funds.
The orphan drug market is broken down into applications of biologics and non-biologics.
The contrasting requirements and different time frames in which this legislation has been enacted have also resulted in considerable differences in the numbers of designated and approved orphan drugs within each market.
NEW YORK -- Since its passage in 1983, the Orphan Drug Act--legislation to facilitate development of orphan drugs, defined as medications for rare conditions such as Huntington's Disease, myoclonus, ALS, Tourette syndrome and muscular dystrophy --has long been considered a success for encouraging the production of hundreds of medications for the Americans suffering from these diseases.
The court found that the Act's plain language generally prohibits the FDA from approving orphan drugs for the same indications that have previously been approved and designated.
Orphan drugs are either drugs or biologics intended for the treatment, diagnosis or prevention of rare diseases which are defined as life-threatening or chronically debilitating conditions affecting less than five in 10,000 people in the European Union per year.