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Competitive Generic Therapy Exclusivity Offers Benefits

Law360 (April 25, 2019, 3:31 PM EDT) -- While a recent Law360 guest article addressing competitive generic therapies pointed out potential pitfalls, we believe that generic drug manufacturers can see considerable benefits from CGT with coordinated execution and thoughtful, strategic planning. But as with many opportunity areas, the devil is in the details, as CGT may also present challenges to applicants, particularly those who are not well-prepared or familiar with the statute.

What is CGT? The FDA Reauthorization Act of 2017 lets generic companies ask for expedited review and 180-day exclusivity for a CGT-designated product. That designation is provided to drugs where, at the time the abbreviated new drug...

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