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Six-Month Market Exclusivity Extensions to Promote Research Offer Substantial Returns for Many Drug Makers
Health Affairs Link to more items from this source
Jan. 19, 2017

"[F]or the thirteen FDA-approved drugs that gained supplemental approval for a rare disease indication from 2005 through 2010, the median projected cost of clinical trials leading to approval was $29.8 million. If the exclusivity extension had been in place, the median discounted financial gain to manufacturers would have been $94.6 million.... Extending market exclusivity would provide substantial compensation to many manufacturers, particularly for top-selling products, far in excess of the cost of conducting these trials."

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