Glenmark gets final nod for Tadalafil Tablets and tentative approvals for Gabapentin Enacarbil ER Tablets and Apremilast Tablets from US FDA

Glenmark Pharma has received final approval by the United States Food & Drug Administration (US FDA) for Tadalafil Tablets USP, 2.5 mg, 5 mg, 10 mg and 20 mg, 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.

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 Extended-Release Tablets, 300 mg and 600 mg, of Arbor Pharmaceuticals. 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. 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 authorised for distribution in the US marketplace and 44 ANDAs pending approval with the US FDA.