Mumbai, Naples | September 17, 2025 – Lupin Limited, one of India’s leading multinational pharmaceutical companies, has announced a significant milestone with the approval of its Abbreviated New Drug Application (ANDA) by the U.S. Food and Drug Administration (FDA) for Lenalidomide Capsules in multiple strengths: 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg.
This approval paves the way for Lupin to enter a multi-billion-dollar market with a high-value oncology product, strengthening its presence in the U.S. generics segment.
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Details of the Approval
Lupin’s Lenalidomide Capsules are bioequivalent to Revlimid® Capsules of Bristol-Myers Squibb Company, which is a leading therapy in oncology care. The manufacturing will be carried out at Lupin’s state-of-the-art facility in Pithampur, India, which has a strong compliance track record with international regulatory authorities.
The product will be made available in all six approved dosage strengths, making Lupin one of the few companies to offer a comprehensive generic portfolio of Lenalidomide in the U.S. market.
Indications and Usage
Lenalidomide is a widely prescribed drug in oncology, offering treatment options for various critical conditions. It is indicated for adult patients in the following settings:
- Multiple Myeloma (MM):
- In combination with dexamethasone.
- As maintenance therapy following autologous hematopoietic stem cell transplantation (auto-HSCT).
- Myelodysplastic Syndromes (MDS):
- For transfusion-dependent anemia due to low- or intermediate-1-risk MDS associated with a deletion 5q abnormality, with or without additional cytogenetic abnormalities.
These indications underline the clinical significance of Lenalidomide as a treatment option for patients battling life-threatening hematological conditions.
Market Opportunity
The approval is a major win for Lupin, given the strong sales of the reference listed drug (RLD). According to IQVIA MAT July 2025, Revlimid® capsules generated estimated annual sales of USD 7.51 billion in the United States.
With generic entry, Lupin is poised to tap into this lucrative market, further consolidating its U.S. generics business and expanding its oncology portfolio.
Strategic Importance for Lupin
This FDA approval highlights Lupin’s commitment to expanding its oncology offerings and building a robust generics portfolio in advanced markets. The company has been strategically focusing on:
- Complex generics and oncology therapies.
- Strengthening manufacturing capabilities in India to serve global demand.
- Leveraging research-driven innovation through its seven R&D centers.
By adding Lenalidomide to its pipeline, Lupin is better positioned to address global healthcare needs while offering affordable alternatives to high-cost branded medications.
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About Lupin
Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with operations in over 100 markets worldwide. The company’s diverse product portfolio includes:
- Branded and generic formulations
- Complex generics
- Biotechnology products
- Active Pharmaceutical Ingredients (APIs)
Lupin holds a strong presence in therapeutic areas such as respiratory, cardiovascular, diabetes, central nervous system (CNS), gastrointestinal, anti-infectives, and women’s health.
With 15 advanced manufacturing sites, 7 research centers, and a dedicated workforce of over 24,000 professionals, Lupin continues to be a trusted healthcare partner globally.
In addition to its core pharmaceutical business, Lupin operates through its subsidiaries:
- Lupin Diagnostics
- Lupin Digital Health
- Lupin Manufacturing Solutions
Together, these divisions strengthen Lupin’s role in enhancing patient health outcomes worldwide.
Official Statement
Commenting on the approval, Lupin’s management emphasized the company’s commitment to bringing high-quality, affordable medicines to patients across the globe. With oncology being a major therapeutic area of focus, Lenalidomide approval marks a significant step in the company’s U.S. growth strategy.
Safe Harbor Statement
Revlimid® is a registered trademark of Celgene Corporation, a Bristol-Myers Squibb Company.
📌 For further information, please contact:
Rajalakshmi Azariah
Vice President & Global Head – Corporate Communications, Lupin
📧 rajalakshmiazariah@lupin.com
🔗 Visit www.lupin.com or follow Lupin on LinkedIn
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