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Benefits of FDA Pediatric Exclusivity

Benefits of FDA Pediatric Exclusivity

Just two weeks after suffering defeat in U.K. patent battles involving pain drug Lyrica (pregabalin), pharma giant Pfizer has secured FDA Pediatric Exclusivity, extending their U.S. market exclusivity for Lyrica through June 30, 2019.
Pediatric Exclusivity is a powerful tool for drug...

ANDA Section VIII Label Carve-Outs Explained

ANDA Section VIII Label Carve-Outs Explained

One objective of the Hatch-Waxman Act was to help facilitate the approval and marketing of generic drugs while simultaneously guarding against patent infringement for the innovator product. Accordingly, the Hatch-Waxman Act requires ANDA applicants to make a certification regarding each of the...

The Importance of Umbrella Exclusivity for Biologics

The Importance of Umbrella Exclusivity for Biologics

Should the exclusivity of the original product protect biologics enhancements? That was one of several questions raised in a recent FDA hearing on Facilitating Price Competition and Innovation in the Biological Products Marketplace held September 4 at the Silver Spring, Maryland...