Lupin gets USFDA nod to market generic version of Sulfamethoxazole and Trimethoprim

The pharmaceutical major Lupin Limited on Wednesday said it has received approval from the US health regulator to market its generic version of sulfamethoxazole and trimethoprim oral suspension used to treat bacterial infections.

Lupin in a statement said, "Lupin Limited (Lupin), a global pharmaceutical company, has received approval for its Sulfamethoxazole and Trimethoprim Oral Suspension USP, 200 mg/40 mg per 5 mL, from the United States Food and Drug Administration, to market a generic equivalent of Bactrim Oral Suspension, 200 mg/40 mg per 5 mL, of Sun Pharmaceutical Industries, Inc."

Sulfamethoxazole and Trimethoprim Oral Suspension USP, 200 mg/40 mg per 5 mL, is indicated for the treatment and prevention of a wide variety of bacterial infections (such as middle ear, urine, respiratory, and intestinal infections), and certain type of pneumonia (pneumocystis-type).

Citing IQVIA MAT September 2020 data, the company said the Sulfamethoxazole and Trimethoprim Oral Suspension USP (RLD: Bactrim) had estimated annual sales of approximately USD 19 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 U.S., 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, gastro-intestinal (GI), central nervous system (CNS) and women's health areas.

Lupin is the third-largest pharmaceutical company in the US by prescriptions and fifth in India by global revenues. The Company invests 9.6 per cent of its revenues on research and development.