Blog

In examining the FDA’s clinical superiority hypothesis requirement for orphan drug designation, it’s helpful to consider the primary purpose of the Orphan Drug Act - to provide incentives for the development of promising orphan drugs that would not otherwise be developed and...

In most cases, the FDA grants orphan drugs a single seven-year exclusivity period for each designation covering a condition or disease. Once the seven years are up, drugmakers can apply for ANDA approval on generic versions of the drug - as long as they carve out any overlapping protected uses or...

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...

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...

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...