Alembic Pharma receives one more ANDA

Alembic Pharmaceuticals Limited announced during the first half of the trading session (at around 10 am to be specific) that it has received tentative approval from United States Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Palbociclib capsules, 75 mg, 100 mg, and 125 mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Ibrance capsules, 75 mg, 100 mg, and 125 mg, of Pfizer Inc.

According to IQVIA, Palbociclib capsules, 75 mg, 100 mg, and 125 mg have an estimated market size of USD 624 million for twelve-month ending June 2020. Alembic Pharma is currently in litigation with Pfizer Inc. in the district court of Delaware. Thus, the launch of the product will depend upon the outcome of the litigation. The press release further added that Alembic Pharma now has a total of 135 ANDA approvals (117 final approvals and 18 tentative approvals) from USFDA.

The stock was trading at Rs 987 at 11 am, i.e. one hour after the announcement. Since the beginning of 2020, the stock of Alembic Pharma has given an absolute return of 77.61 per cent thereby, outperforming the broader market index, S&P BSE 500, which delivered a return of 1.48 per cent.