Glenmark gets USFDA nod for generic drug with 180-day exclusivity

Glenmark Pharmaceuticals on Thursday said it has received an approval from the US health regulator to market a generic medication to treat plaque psoriasis.

The company has received final approval from the US Food & Drug Administration (USFDA) for Calcipotriene and Betamethasone Dipropionate Foam, the generic version of Leo Pharma's Enstilar, Glenmark Pharma said in a statement.

The USFDA noted that the Mumbai-based drug firm was the first abbreviated new drug application (ANDA) applicant with a paragraph IV certification for Calcipotriene and Betamethasone Dipropionate Foam, it added.

''Therefore, with this approval, Glenmark is eligible for 180 days of generic drug exclusivity for Calcipotriene and Betamethasone Dipropionate Foam,'' the drug firm said.

According to IQVIA sales data for the 12-month period ended January 2023, Enstilar Foam (0.005 per cent/0.064 per cent) achieved annual sales of around USD 93.6 million.

Shares of the company were trading 0.49 per cent down at Rs 434.20 apiece on the BSE.

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