Glenmark Pharmaceuticals Inc., has been granted tentative approval by the USFDA for its Dronedarone Tablets, 400 mg, the generic version Multaq Tablets, 400 mg of Sanofi-Aventis U.S.
As the company explained in its press release, “Tentative approval” means that FDA has concluded that a drug product has met all requirement quality, safety and efficacy standards, but is not eligible for marketing in the U.S. because of existing patent protections or exclusivities.
Glenmark said it believes it is one of the first companies to have filed a substantially complete ANDA containing a Paragraph VI certification for Dronedarone Tablets and expects to be eligible for 18 days of generic drug exclusivity upon final FDA approval. Glenmark remains involved in a patent litigation in the U.S. District Court for the District of Delaware, wherein Sanofi and Sanofi-Aventis U.S. has asserted its patents.
Furthermore, according to IMS Health sales data for the 12 monhth period ending November 2015, Glenmark notes, the Multaq market achieved annual sales of about $425,7 million.