Lupin has secured a tentative approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application for Letermovir Tablets, 240 mg and 480 mg, to market a generic equivalent of Prevymis Tablets, 240 mg and 480 mg, of Merck Sharp & Dohme LLC.

This product will be manufactured at Lupin’s Nagpur facility in India.

Letermovir Tablets, 240 mg and 480 mg are indicated for prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant.

Letermovir Tablets (RLD Prevymis) had an estimated annual sale of USD 314 million in the US. Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India.

The company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the US, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

The company enjoys a leadership position 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. Lupin is the third-largest pharmaceutical company in the US by prescriptions. The company invested 7.8 percent of its revenue in research and development in FY24.