Last Minute Dissolution Testing Requirement Avoids Forfeiture of 180-Day Exclusivity for Generic COREG CR Staggered Strengths

By Kurt R. Karst — As folks know by now, each month we pore over the latest Orange Book Cumulative Supplement in an effort to keep our popular 180-Day Exclusivity Tracker as current as possible, and to look for interesting precedents. One recent entry in particular caught our attention.  It was for ANDA 090132 for Carvedilol Phosphate Extended-Release Capsules, 10 mg, 20 mg, 40 mg and 80 mg, a generic version of SmithKline’s COREG CR Extended-Release Capsules (NDA 022012).  The Orange Book Cumulative Supplement showed the addition of periods of “PC” exclusivity (i.e., 180-day patent challenge exclusivity) expiring on May 7, 2018 for all four strengths covered under the ANDA now owned by Sun Pharmaceutical Industries Inc. (“Sun”) (formerly owned by Mutual Pharmaceutical Company, Inc. (“Mutual”)).  What made the entry of 180-day exclusivity interesting is that FDA’s October 25, 2017 letter approving the ANDA…

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