Axinn successfully advocated that FDA should preserve the 180-day marketing exclusivity period relating to a generic version of SmithKline’s Coreg CR (carvedilol phosphate extended-release capsules) even though it took the ANDA applicant over 10 years to obtain tentative approval of its product.  Through a series of correspondence submitted to FDA over the course of a number of years, Axinn successfully convinced FDA that the 180-day exclusivity period was not forfeited by Mutual Pharmaceutical Company (now Sun Pharma) because of a change in the approval requirements for the product. The Axinn team was led by Chad Landmon.

Click here to read FDA's decision and here to read press coverage on FDA Law Blog.