Like a Bad Penny, Pre-MMA 180-Day Exclusivity Keeps Turning Up!
By Kurt R. Karst –
Although it’s been more than 10 years since the December 8, 2003 enactment of the Medicare Modernization Act (“MMA”) – or, more accurately, The Medicare Prescription Drug, Improvement, and Modernization Act, Pub. L. No. 108-173 – which created a new regime for 180-day generic drug marketing exclusivity, the pre-MMA version of the statute governing 180-day exclusivity is still alive and kicking. In fact, because of how the pre-MMA-to-post-MMA changeover operates, pre-MMA 180-day exclusivity may be around for quite some time, frustrating some generic drug applicants along the way, but rewarding others.
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Although it’s been more than 10 years since the December 8, 2003 enactment of the Medicare Modernization Act (“MMA”) – or, more accurately, The Medicare Prescription Drug, Improvement, and Modernization Act, Pub. L. No. 108-173 – which created a new regime for 180-day generic drug marketing exclusivity, the pre-MMA version of the statute governing 180-day exclusivity is still alive and kicking. In fact, because of how the pre-MMA-to-post-MMA changeover operates, pre-MMA 180-day exclusivity may be around for quite some time, frustrating some generic drug applicants along the way, but rewarding others.
continue to read here