Glenmark Pharmaceuticals, a manufacturer of generic formulation products and API, announced that the company's US arm has been granted tentative approval by the United States Food & Drug Administration (USFDA) for its Dronedarone tablets, 400 mg.
The company said, "Glenmark is one of the first companies to have filed a substantially complete abbreviated new drug application (ANDA) containing a paragraph IV certification for Dronedarone tablets and expects to be eligible for 180 days of generic drug exclusivity upon final USFDA approval."
"Glenmark remains involved in a patent litigation in the U.S. court for the district of Delaware, wherein Sanofi and Sanofi-Aventis U.S., LLC has asserted its patents," it added.
'Tentative approval' means that USFDA has concluded that a drug product has met all required quality, safety and efficacy standards, but is not eligible for marketing in the U.S. because of existing patent protections or exclusivities.
These tablets are the generic version of Multaq tablets, 400 mg of Sanofi-Aventis U.S., LLC. According to IMS Health sales data for the 12 month period ending November 2015, the Multaq market achieved annual sales of approximately USD 425.7 million.
Shares of the company gained Rs 2.2, or 0.24%, to trade at Rs 935.00. The total volume of shares traded was 33,795 at the BSE (11.35 a.m., Wednesday).