Lupin shares trade 3% higher on tentative USFDA approvals

On November 23, Lupin announced receiving the USFDA’s tentative approval for its Abbreviated New Drug Application (ANDA) for Canagliflozin Tablets to market a generic equivalent of Invokana Tablets of Janssen Pharmaceuticals, Inc at its Pithampur facility.

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Shares of Lupin opened 3 percent higher during early trade on the NSE on November 24, a day after it announced tentative approval from the United States Food and Drug Administration (USFDA) for diabetes medication. At 9:20am, the stock was trading at Rs 1,232.15.

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On November 23, Lupin announced receiving the USFDA’s tentative approval for its Abbreviated New Drug Application (ANDA) for Canagliflozin Tablets to market a generic equivalent of Invokana Tablets of Janssen Pharmaceuticals, Inc at its Pithampur facility.

Canagliflozin Tablets, according to the release, had estimated annual sales of $561 million in the US.

The pharma major also received USFDA approval for its ANDA concerning Bromfenac Ophthalmic Solution, 0.07 percent. According to the release, the approval positions Lupin as the exclusive first-to-file entity for this generic equivalent of Bausch & Lomb Inc’s Prolensa Ophthalmic Solution, 0.07 percent, making the company eligible for a coveted 180-day exclusivity period.

Also Read: Lupin launches world’s first fixed-dose triple combination drug for chronic lung disease

In Q2FY24, Lupin reported a 277 percent year-on-year rise in consolidated net profit to Rs 489.6 crore for the quarter ending September 2023. Revenue for the same period grew to Rs 5038.56 crore in Q2FY24 from Rs 4145.5 crore in Q2FY23.

The company’s earnings before interest, taxes, depreciation and amortization (EBITDA) grew to Rs 958.2 crore from Rs 468 crore in the year-ago period, while the EBITDA margin was at percent 19.4 against 11.4 percent.

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