Lupin secures a tentative USFDA approval for Rivaroxaban tablets

The Mumbai-headquartered pharmaceutical giant Lupin Limited announced today that it has secured tentative approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Rivaroxaban Tablets. These tablets are a generic equivalent of Janssen Pharmaceuticals' Xarelto Tablets, a popular blood thinner used for various cardiovascular conditions.

The approved tablets come in four dosages - 2.5 mg, 10 mg, 15 mg, and 20 mg - and are indicated for a wide range of conditions, including reducing the risk of stroke and systemic embolism in nonvalvular atrial fibrillation, treating deep vein thrombosis (DVT) and pulmonary embolism (PE), reducing major cardiovascular events in patients with coronary artery disease (CAD), etc.

The approval allows Lupin to enter the lucrative market for anticoagulant medications, providing more alternatives to patients. The company will manufacture Rivaroxaban Tablets at its facility in Pithampur, India.

Xarelto, the reference listed drug (RLD), had estimated annual sales of USD 8,249 million in the US as of November 2023, according to IQVIA.

Lupin’s portfolio includes branded and generic formulations, biotechnology products, and Active Pharmaceutical Ingredients (APIs). The company operates in over 100 markets globally, with a presence in the US, South Africa, Asia Pacific, Latin America, Europe, and the Middle East.

Lupin holds leadership positions in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastrointestinal (GI), central nervous system (CNS), and women’s health areas. In the US, Lupin ranks as the third-largest pharmaceutical company by prescriptions.

Lupin boasts 15 manufacturing sites, 7 research centres, and a global team of more than 20,000 professionals.

The same day, Lupin’s share price rose by 2.15 per cent, ending the day's trade at Rs 1,440 apiece on the Bombay Stock Exchange (BSE).