Glenmark Pharmaceuticals, on March 23, received final approval by the United States Food and Drug Administration (US FDA) for Calcipotriene and Betamethasone Dipropionate Foam, which is the generic version of Enstilar 1 Foam of Leo Pharma AS.
On The Basis of 180-day generic drug exclusivity, the FDA noted that Glenmark was the first Abbreviated New Drug Application (ANDA) applicant to submit a substantially complete ANDA with a certification for Calcipotriene and Betamethasone Dipropionate Foam. The drug is an analogue and synthetic corticosteroid fixed-dose combination foam formulation, which is used for the topical treatment of plaque psoriasis in adults.
Hence, with this approval, Glenmark is eligible for 180 days of generic drug exclusivity for the drug. According to IQVIA sales data for the 12 months ending January 2023, Enstilar Foam achieved annual sales of approximately $93.6 million.
With this approval from the US FDA, Glenmark now has a current portfolio of 183 authorised products for distribution in the US and 45 ANDA pending approvals.
In an interview with CNBC-TV18, Glenmark Pharma’s Executive Director and Global Chief Financial Officer (CFO) said that he expects US sales to be around $100 million on a sequential basis.
“Keep FY23 growth target close to 6 percent. We are doing our best in terms of remediation and are confident about reducing debt via internal accruals. We don’t need to divest more brands in India,” he added.
On January 27, the company’s Baddi facility was provided with an exception by the US FDA for the export of atovaquone oral suspension while the facility was still under an import alert. This step was taken due to medical necessity and drug shortage expectations.
Glenmark Pharma reported a rise of 23 percent in quarter three net profits, while the EBITDA margin was seen declining by nearly 400 basis points (bps). The stock is currently trading with cuts of nearly 1 percent at Rs 433 per share.
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