Market exclusivity: orphan medicines | European Medicines ...
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Expiry of market exclusivity ... When the period of market exclusivity for an indication ends, the orphan designation for that indication expires and the European ... Skiptomaincontent Menu Medicines Medicines Search Download Whatwepublishandwhen
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- 1Designating an Orphan Product: Drugs and Biological ...
The Orphan Drug Act (ODA) provides for granting special status to a drug or biological product (“...
- 2Orphan drug - Wikipedia
An orphan drug is a pharmaceutical agent developed to treat medical conditions which, because the...
- 3The Enduring Role of Orphan Drug Exclusivity for Biologics ...
Orphan Drugs receive a 7-year period of exclusivity from product approval - effective on the date...
- 4Market exclusivity: orphan medicines | European Medicines ...
Expiry of market exclusivity ... When the period of market exclusivity for an indication ends, th...
- 5Marketing Exclusivity for Drug Developers: What is it ...
Orphan drug exclusivity (ODE; 21 CFR 316.31) is used as an incentive to promote the development o...
