Glenmark secures USFDA nod for Tadalafil, Gabapentin Enacarbil, Apremilast Tablets
Mumbai: Drug major, Glenmark Pharmaceuticals Limited, today announced that the company has received United States Food & Drug Administration (USFDA) final approval for Tadalafil Tablets, tentative approvals for Gabapentin Enacarbil Extended-Release Tablets and Apremilast Tablets.
Tadalafil Tablets USP, 2.5 mg, 5 mg, 10 mg and 20 mg is the generic version of Cialis 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 market achieved annual sales of approximately $125.5 million*.
The company has also received tentative approval by the USFDA for Gabapentin Enacarbil Extended-Release Tablets, 300 mg and 600 mg, the generic version of Horizant 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.
Glenmark Pharmaceuticals Ltd. is a global research-led pharmaceutical company with presence across Generics, Specialty and OTC business with operations in over 50 countries.
Glenmark's key therapy focus areas globally are respiratory, dermatology and oncology.