Glenmark receives one ANDA approval and two tentative ANDA approvals - Tadalafil Gabapentin Enacarbil and Apremilast
Dec 31, 2020
Mumbai (Maharashtra)[India], December 31 (ANI/PRNewswire): Glenmark Pharmaceuticals Limited (Glenmark), a research-led global pharmaceutical company has received final approval by the United States Food & Drug Administration (U.S. FDA) for Tadalafil Tablets USP, 2.5 mg, 5 mg, 10 mg and 20 mg, the generic version of Cialis®1 Tablets, 2.5 mg, 5 mg, 10 mg and 20 mg, of Eli Lilly and Company.
According to IQVIA™ sales data for the 12 month period ending November 2020, the Cialis® Tablets, 2.5 mg, 5 mg, 10 mg and 20 mg market2 achieved annual sales of approximately $125.5 million*.
Glenmark has also received tentative approval by the US FDA for Gabapentin Enacarbil Extended-Release Tablets, 300 mg and 600 mg, the generic version of Horizant®1 Extended-Release Tablets, 300 mg and 600 mg, of Arbor Pharmaceuticals, LLC. The Horizant® market achieved annual sales of approximately $99.5 million.
Additionally, Glenmark has received tentative approval for Apremilast Tablets, 10 mg, 20 mg and 30 mg, the generic version of Otezla® Tablets, 10 mg, 20 mg and 30 mg, of Amgen, Inc. The Otezla® Tablets, 10 mg, 20 mg and 30 mg market achieved annual sales of approximately $2.7 billion.
Glenmark's current portfolio consists of 167 products authorized for distribution in the U.S. marketplace and 44 ANDA's pending approval with the U.S. 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.
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