Sun Pharmaceutical Industries announced that the US FDA has granted its subsidiary, two tentative approvals for its Abbreviated New Drug Applications (ANDA) for generic version of Januvia, sitagliptin tablets and generic version of Glumetza, metformin HCl extended-release tablets. Januvia is a registered trademark of Merck Sharp & Dohme Corporation (MSD) while Glumetza is a registered trademark of Santarus.
The announcement has stirred interest in the industry as Sun Pharma was a co-plaintiff in MSD’s appeal to the Delhi High Court move to block Glenmark Pharma’s April 2 move to market its generic versions of MSD’s Januvia and Janumet, named Zita and Zita Met. Sun Pharma has a license from MSD to sell these drugs as its brands, Istavel and Istamet, in the India market.
Sitagliptin tablets, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes mellitus, have annual sales of approximately $2.7 billion in the US. Metformin HCl Extended-release tablets have annual sales of approximately $140 million in the US. They are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes mellitus.
EP News Bureau – Mumbai