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Generic Drugs: ‘Competitive’ Exclusivity Benefited Few Sponsors But Is Increasingly Popular

 
• By Derrick Gingery

The six months of additional exclusivity from US FDA’s CGT program appears to have kept some generic sponsors from the market, and didn’t even prompt others to enter quickly, but use of the competitive generic exclusivity program continues to grow.

leading competition
Twelve CGT approvals have seen follow-on competition approved just after exclusivity expired, suggesting an advantage to the designation. • Source: Alamy

Competitive generic therapy exclusivity in some cases is holding additional competitors from the market, but only in a small portion of the products approved through the program so far.

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