Lupin Ltd , a global pharmaceutical leader, has announced the launch of Liraglutide injection for blood sugar control in the United States, marking a significant expansion of its complex injectables portfolio. The product is available as an 18 mg/3 mL prefilled pen for adults and children aged 10 years and above with type 2 diabetes.

Product Details and Market Potential

Lupin's Liraglutide Injection is bioequivalent to Novo Nordisk's Victoza®, which has estimated annual US sales of approximately $350.00 million. This launch represents a significant opportunity for Lupin in the U.S. market.

Additional FDA Approvals

In addition to the Liraglutide injection launch, Lupin has received several other important FDA approvals:

1. The company received USFDA approval for Rivaroxaban oral suspension (1 mg/mL), which is bioequivalent to Janssen's Xarelto. This medication is indicated for treating venous thromboembolism in pediatric patients.

2. Lupin also received tentative FDA approval for a generic version of Biktarvy tablets for HIV treatment. This product contains bictegravir, emtricitabine, and tenofovir alafenamide. According to IQVIA MAT data, Biktarvy had estimated annual US sales of $16.20 billion.

Company Background and Strategic Importance

Lupin Limited, headquartered in Mumbai, India, is a global pharmaceutical company with products distributed in over 100 markets. The company specializes in a wide range of pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.

With 15 state-of-the-art manufacturing sites and 7 research centers globally, Lupin employs over 24,000 professionals. The company has a strong presence in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health.

These recent launches and approvals underscore Lupin's commitment to expanding its product portfolio and strengthening its position in the U.S. pharmaceutical market, particularly in the treatment of diabetes, cardiovascular diseases, and HIV.

Stock Performance

Following these announcements, Lupin shares closed 0.32% lower at ₹1,975.00 on the National Stock Exchange (NSE).

Lupin Limited , a global pharmaceutical leader, has achieved a significant milestone in its product portfolio expansion. The company recently announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Rivaroxaban for Oral Suspension, 1 mg/mL.

Key Highlights

• Lupin's Rivaroxaban for Oral Suspension is bioequivalent to Janssen Pharmaceuticals, Inc.'s Xarelto® for Oral Suspension, 1 mg/mL.
• The product will be manufactured at Lupin's Chhatrapati Sambhajinagar facility in India.
• Estimated annual sales of Rivaroxaban for Oral Suspension, 1 mg/mL in the U.S. market stand at USD 11.00 million (IQVIA MAT July 2025).

Therapeutic Applications

Rivaroxaban for Oral Suspension is indicated for:

1. Treatment of venous thromboembolism (VTE) and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years, after at least 5 days of initial parenteral anticoagulant treatment.
2. Treatment of thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure.

Market Impact

This approval marks an important addition to Lupin's cardiovascular therapy area, one of the company's key focus areas. The introduction of Rivaroxaban for Oral Suspension will provide healthcare professionals with an additional option for pediatric patients requiring anticoagulant therapy.

About Lupin Limited

Lupin Limited is a global pharmaceutical company headquartered in Mumbai, India, with a presence in over 100 markets. The company specializes in a wide range of pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.

With 15 state-of-the-art manufacturing sites and 7 research centers globally, Lupin employs over 24,000 professionals dedicated to improving patient health outcomes. The company has a strong presence in India and the United States across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health.

This latest FDA approval reinforces Lupin's commitment to expanding its product offerings and strengthening its position in the global pharmaceutical market, particularly in the critical area of pediatric care.