Alembic Pharmaceuticals receives final USFDA approval for Doxycycline Capsules used for treatment of inflammatory lesions

The company reported that the approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Oracea Capsules, 40 mg, belonging to Galderma Laboratories. Doxycycline capsules are used for the treatment of only inflammatory lesions such as papules and pustules of rosacea in adult patients.

The company cited IQVIA’s data for the 12 months ending March 2024 and reported that Doxycycline Capsules, 40 mg have an estimated market size of approximately $123 million.

Alembic Pharmaceuticals have a total of 205 ANDA approvals, of which, 179 have received final approvals while 26 have received tentative approvals from the USFDA.

Earlier this month, Alembic Pharmaceuticals received final USFDA approval for Dabigatran Etexilate Capsules, 75 mg and 150 mg. The firm also received tentative approval for Dabigatran Etexilate Capsules, 110 mg. Alembic Pharmaceuticals said the approved ANDA is therapeutically equivalent to the reference listed drug product Pradaxa Capsules, 75 mg, 110 mg, and 150 mg of Boehringer Ingelheim Pharmaceuticals, Inc.

Dabigatran Etexilate Capsules 75 mg and 150 mg have an estimated market size of $179 million for twelve months ending in March 2024, according to IQVIA. At the same time, Dabigatran Etexilate Capsules 110 mg have an estimated market size of $5 million.

During the fourth quarter of fiscal year 2024, the company announced a 175 rise in its net profit at ₹178 crore. Net sales rose 8% during the quarter to ₹1,517 crore. Earnings before interest, tax, depreciation, and amortisation (EBITDA) rose 29% to ₹263 crore. For the full fiscal year 2024, net profit rose 80% to ₹616 crore while net sales increased 10% to ₹6,229 crore. EBITDA rose 41% to ₹961 crore.

Shares of the company have risen by nearly 22% since the beginning of the year. The stock has gained over 53% in the last one year.