Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (USFDA) for Bendamustine Hydrochloride for Injection, 25 mg/vial and 100 mg/vial, the therapeutic equivalent to the reference listed drug product, Treanda for Injection, 25 mg/vial and 100 mg/vial, of Cephalon, Inc. This marks Glenmark’s first injectable granted approval by the USFDA.
Under the terms of the prior settlement agreement, Glenmark will be able to launch its product on November 1, 2019, or earlier under certain circumstances. Glenmark was one of the first ANDA applicants to submit a substantially complete ANDA with a Paragraph IV certification, therefore, Glenmark may be eligible for 180 days of marketing exclusivity for Bendamustine Hydrochloride for Injection, 25 mg/vial and 100 mg/vial.
According to IMS Health sales data for the 12 month period ending January 2016, the Treanda for Injection, 25 mg/vial and 100 mg/vial Market achieved annual sales of approximately $92.6 million.
Glenmark’s current portfolio consists of 110 products authorized for distribution in the US marketplace and 59 ANDA’s pending approval with the USFDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.
