Alembic Pharma gets tentative USFDA nod for Ivosidenib tablets, shares climb 2%

Alembic Pharmaceuticals announced on Wednesday it has received tentative approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Ivosidenib tablets, 250 mg. The company reported that the approved ANDA is therapeutically equivalent to Servier Pharmaceuticals’ Tibsovo Tablets, 250 mg.

Following the announcement, shares of Alembic Pharma were trading higher by over 2%.

According to IQVIA’s data for the 12 months ended March 2024, the market size of Ivosidenib tablets, 250 mg, is estimated at $114 million.

Alembic Pharmaceuticals has a total of 207 ANDA approvals, of which 179 have received final approvals while 28 have received tentative approvals.

Last week, Alembic Pharmaceuticals announced it has received the final approval from the USFDA for its ANDA for Doxycycline Capsules, 40 mg. 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 stated.

The firm 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.

During the fourth quarter of fiscal year 2024, the company announced a 17% 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 25% since the beginning of the year. The stock has gained nearly 50% in the last one year.