Lupin Limited has secured approvals from the U.S. Food and Drug Administration (FDA) for several generic drugs, addressing critical needs in HIV treatment, cystic fibrosis, and heart failure. These approvals underscore Lupin's commitment to providing affordable and accessible healthcare solutions. The FDA's decisions include final approval for a heart failure medication and tentative approvals for HIV and cystic fibrosis treatments.
Heart Failure Therapy Approval
The FDA has approved Lupin's Abbreviated New Drug Application (ANDA) for Sacubitril and Valsartan tablets, a generic version of Novartis' Entresto. This medication is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure and reduced ejection fraction. It is also approved for treating symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. The approval covers dosages of 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg. The U.S. market for Sacubitril and Valsartan tablets is estimated at $6.06 billion annually.
HIV Treatment for Pediatric Patients
Lupin has also received tentative FDA approval under the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) for its ANDA for Abacavir, Dolutegravir, and Lamivudine tablets for oral suspension (60 mg/5 mg/30 mg). This product is a generic equivalent of ViiV Healthcare's Triumeq PD tablets for oral suspension. The fixed-dose combination is a once-daily, single-pill regimen indicated for the treatment of HIV-1 infection in pediatric patients aged at least 3 months and weighing at least 6 kg. The tablets will be manufactured at Lupin’s Nagpur facility in India and supplied to low- and middle-income countries. According to IQVIA data, Triumeq PD had estimated annual sales of USD 1.3 million in the U.S. as of September 2024.
Ramesh Swaminathan, Executive Director, Global CFO & Head of API Plus SBU, Lupin, stated, “We are committed to providing affordable and high-quality treatments for patients worldwide. The tentative approval from the U.S. FDA for our Abacavir, Dolutegravir and Lamivudine tablets enables us to improve the well-being of pediatric patients with HIV-1, thereby significantly boosting our HIV medication portfolio.”
Cystic Fibrosis Treatment
Additionally, Lupin received tentative approval from the FDA for its ANDA for Ivacaftor oral granules (25 mg, 50 mg, and 75 mg per unit dose packet), a generic equivalent of Vertex Pharmaceuticals' Kalydeco oral granules. Lupin is the exclusive first-to-file for this product and may be eligible for 180 days of generic drug exclusivity. Ivacaftor oral granules are indicated for the treatment of cystic fibrosis (CF) in patients aged 4 months and older who have at least one mutation in the CFTR gene that is responsive to ivacaftor. Kalydeco oral granules had estimated annual sales of USD 51 million in the U.S. (IQVIA MAT November 2024).
Manufacturing and Market Impact
All three products will be manufactured at Lupin’s Nagpur facility in India. The approvals for these generic drugs are expected to significantly impact the availability and affordability of treatments for heart failure, HIV, and cystic fibrosis, particularly in low- and middle-income countries.
