Glenmark Pharmaceuticals Inc., USA (Glenmark) has received final US FDA approval 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.
Under the terms of the prior settlement agreement, Glenmark will be able to launch bendamustine hydrochloride for injection 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.
Further, Glenmark has also received final approval by the US FDA for drospirenone and ethinyl estradiol tablets USP, 3 mg/0.03 mg, the generic version of Yasmin tablets of Bayer HealthCare Pharmaceuticals Inc. (Bayer) and for levonorgestrel tablet, 1.5 mg, the generic version of Plan B One-Step tablet of Teva Branded Pharmaceutical Products R&D, Inc., for over-the-counter (OTC) use as recommended in the submitted labelling.
According to IMS Health sales data for the 12 month period ending January 2016, the Yasmin market achieved annual sales of approximately $131.7 million and the Plan B One-Step tablet OTC market achieved annual sales of approximately $45.2 million.
Glenmark’s current portfolio consists of 110 products authorized for distribution in the US marketplace and 59 ANDA’s pending approval with the US FDA. 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.