Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (USFDA) for Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg and 0.25 mg/0.025 mg, the generic version of Ortho Tri-Cyclen Lo Tablets of Janssen Pharmaceuticals, Inc.
According to IMS Health sales data for the 12 month period ending December 2015, the Ortho Tri-Cyclen Lo Tablets market achieved annual sales of approximately $503.9 million.
The company’s current portfolio consists of 107 products authorized for distribution in the U.S. marketplace and 62 ANDA’s pending approval with the USFDA. In addition to these internal filings, the company continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.
