Alembic Pharma receives USFDA nod for generic Selexipag Injection

16 Jul 2024 , 03:08 PM

Alembic Pharmaceuticals Ltd announced on Monday that it has received tentative approval from the US Food & Drug Administration (USFDA) for its generic version of Selexipag injection, used to treat pulmonary arterial hypertension.

The approval pertains to the abbreviated new drug application (ANDA) for Selexipag injection at a strength of 1,800 mcg/vial. This generic version is considered therapeutically equivalent to Uptravi for Injection, 1,800 mcg/vial, manufactured by Actelion Pharmaceuticals US, Inc.

At the time of writing on July 16, 2024 at 3:02 pm, shares of Alembic Pharmaceuticals Ltd is currently trading at ₹1093 which is a 11.38% gain than the previous close. The stock has gained a total of 65% in the last one year and 42% since the beginning of the year.

Alembic Pharmaceuticals is noted as the first applicant to submit an ANDA for Selexipag for Injection, 1,800 mcg/vial, which includes a Paragraph IV certification under the Hatch-Waxman Act. This certification allows a company to apply for approval of a generic drug before the patents of the brand-name drug expire.

Upon final approval by the USFDA, Alembic Pharmaceuticals may qualify for 180 days of marketing exclusivity in the US for its Selexipag generic.

Selexipag is prescribed for treating pulmonary arterial hypertension (PAH), a rare condition characterized by elevated blood pressure in the lungs’ arteries, aiming to slow disease progression and lower hospitalization risk.

Alembic Pharmaceuticals Ltd. is an Indian multinational pharmaceutical company headquartered in Vadodara, Gujarat. It is renowned for manufacturing pharmaceutical products, substances, and intermediates, particularly excelling in the macrolides segment of anti-infective drugs within India.

The company operates major manufacturing facilities in Panelav, Karakhadi (Gujarat), and Sikkim, India. The Panelav site is dedicated to producing active pharmaceutical ingredients (APIs) and formulations, while the Sikkim facility focuses on manufacturing formulations for both the domestic Indian market and non-regulated export markets.