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  1. Lupin announces launch of first generic version of Oracea after receiving approval from the USFDA

Lupin announces launch of first generic version of Oracea after receiving approval from the USFDA

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2 min read • Updated: April 10, 2024, 10:53 AM

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Summary

Lupin said that Doxycycline Capsules had an estimated annual sales of $128 million in the U.S. Doxycycline Capsules, 40 mg, is indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients, the company said in a release.

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Shares of lupin are trading marginally higher

Pharma major Lupin has announced the launch of its first generic version of Oracea (Doxycycline Capsules, 40 mg) in the United States, after having received an approval from the United States Food and Drug Administration (USFDA).

In an exchange filing, the drugmaker said that Doxycycline Capsules had an estimated annual sales of $128 million in the U.S. Doxycycline Capsules, 40 mg is indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients.

Lupin recently said that it is proposing to transfer its trade generics business in India along with all related assets and liabilities to Lupin Life Sciences, a wholly-owned subsidiary of the company. The completion of sale is expected to be done by June 30, 2024, it said in an exchange filing. The consideration expected to be received stands at ₹100-120 crore, Lupin had said.

The drug-maker indicated that the slump sale will lead to agility, better focus and growth of trade generics business. It is also expected to increase business by investing in new launches and penetrating underserved markets. Trade generics are poised for higher growth given the need for accessibility, availability and affordability of medicines, it said but added there is specific focus required to achieve this.

Meanwhile, Lupin had recently announced the appointment of Ranjana Pathak as Chief Quality Officer, succeeding Johnny Mikell who, it said, will be retiring from the services of the company.

For the third quarter of fiscal year 2024, Lupin had reported a 19.7% year-over-year (y-o-y) rise in its sales at ₹5,079.90 crore. Earnings before interest, tax, depreciation and amortisation (EBITDA) increased 93.8% to ₹1,067.30 crore. EBITDA margin improved by 800 basis points to 21%. Net profit jumped 292.6% to ₹618.70 crore during the quarter.

Shares of Lupin are trading marginally higher at ₹1,615 apiece on the NSE at 10:50 am . The stock has risen over 141% in the last one year.