Lupin Receives FDA Approval for Raltegravir Tablets USP, 600 mg

• Key Highlights:
  • Lupin receives FDA approval for Raltegravir Tablets USP, 600 mg.
  • Product is bioequivalent to Isentress HD Tablets, 600 mg of Merck Sharp & Dohme LLC.
  • Lupin gets 180 days of generic drug exclusivity.
  • Estimated annual sales of Raltegravir Tablets USP, 600 mg in the US is USD 34 million.

What This Means for You

• This approval is a positive for Lupin, expanding its product portfolio and giving it a competitive advantage in the US market.
• However, Lupin's ability to capitalize on this opportunity depends on its manufacturing capacity, pricing strategy, and marketing efforts.

Lupin Expands US Product Portfolio

• Key Highlights:
  • Lupin launches Eslicarbazepine Acetate Tablets in the US
  • Estimated annual sales of USD 395 million in the US
  • Eligible for 180-day shared generic exclusivity
  • Global pharmaceutical leader with products in over 100 markets

What This Means for You

This launch is a positive for Lupin, expanding its US presence. However, the large market size may attract competition, potentially impacting Lupin's market share. Monitor the company's performance and US market dynamics.

Lupin Limited has received approval from the US FDA for its Abbreviated New Drug Application for Tolvaptan Tablets, which are bioequivalent to Jynarque Tablets. Lupin is the exclusive first-to-file for this product and is eligible for 180 days of generic drug exclusivity. The product will be manufactured at Lupin's Nagpur facility in India and will be launched soon. Tolvaptan is indicated to slow kidney function decline in adults with autosomal dominant polycystic kidney disease. The product had an estimated annual sale of USD 1,467 million in the US in 2024.

Lupin Diagnostics Limited, a subsidiary of Lupin Limited, has achieved 100% NABL accreditation across all its greenfield labs. This accreditation is a testament to the company's commitment to quality and patient care. The company operates 27 greenfield labs across the country, ensuring timely and accurate reporting. Lupin Diagnostics has received several accolades, including 'Patient-Centric Diagnostic Laboratories Company of the Year' and 'Pathology Lab of the Year'. The company provides a comprehensive range of diagnostic services to doctors, patients, and consumers.

Lupin Limited has received the Establishment Inspection Report (EIR) from the US FDA for its injectable facility in Nagpur, India. The EIR was issued following an inspection conducted from June 10 to 13, 2024. The company remains committed to producing complex generic and essential products that address unmet needs.