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What US Orphan Drugs Have Exclusivity Expiring ?

January 15, 2013

Michael Glessner, from Thomson Reuters, writes a November 2012 article on the expiration of Orphan Drug Exclusivity (ODE) in the United States, and what opportunities this presents to generic and Active Pharmaceutical Ingredient (API) manufacturers. The article is written for CHEManager, Germany’s publication for the chemical industry.

Per this article, 70 US orphan drugs will lose their ODE over the next 6 years. This provides an opportunity for manufacturers of generics and APIs contained in generic products :

“ … Because ODEs are not tied to patents, generics manufacturers can develop and often launch a drug protected by an ODE so long as the drug is approved for a different, non-infringing application ….. According to research compiled by Thomson Reuters, manufacturers are already producing or capable of producing commercial quantities of many of the APIs associated with drugs currently protected by ODEs …”.

Key to this article is Table 1 (available online), titled “API Development of Orphan Drugs”, which lists a small sample of the ODEs that expire 2013 – 2016, and the # of API manufacturers “who currently have these drugs under development or commercially available according to information in Thomson Reuters Newport Premium”.

The article concludes that as the ODEs expire over the next few years, “generics and API manufacturers are poised to cash in on these once-ignored now profitable markets”.

Copyright © 2012-2013, Orphan Druganaut Blog. All rights reserved.

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