Incentives for orphan drug research and development in the United States
Open Access
- 16 December 2008
- journal article
- research article
- Published by Springer Nature in Orphanet Journal of Rare Diseases
- Vol. 3 (1), 33
- https://doi.org/10.1186/1750-1172-3-33
Abstract
The Orphan Drug Act (1983) established several incentives to encourage the development of orphan drugs (ODs) to treat rare diseases and conditions. This study analyzed the characteristics of OD designations, approvals, sponsors, and evaluated the effective patent and market exclusivity life of orphan new molecular entities (NMEs) approved in the US between 1983 and 2007.Keywords
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