n a landmark development for global cancer care, Cipla Limited (BSE: 500087; NSE: CIPLA EQ), a leading global pharmaceutical company, today announced that it has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Lenalidomide Capsules, a generic therapeutic equivalent to Revlimid®, developed by Bristol Myers Squibb.

Lenalidomide is a widely prescribed oral cancer treatment used in combination therapy or as a monotherapy for certain hematologic malignancies, including multiple myeloma, myelodysplastic syndromes (MDS), mantle cell lymphoma (MCL), and follicular lymphoma (FL). Cipla’s approval encompasses a comprehensive suite of strengths—5 mg, 10 mg, 15 mg, and 25 mg—bringing critical therapeutic options to patients in the U.S. and, eventually, other regulated markets.

Expanding Access to Life-Saving Cancer Therapies
This final FDA approval underscores Cipla’s commitment to delivering high-quality, cost-effective generics in complex therapy areas. Lenalidomide is classified as a Biosafety Level 2 hazardous drug, requiring advanced manufacturing and handling protocols, which Cipla has effectively met through its USFDA-inspected, world-class manufacturing facility in India.

With the rising burden of cancer—over 1.9 million new cancer cases are projected in the U.S. for 2025—the availability of cost-effective generics like Cipla’s Lenalidomide can significantly reduce the economic burden on patients and the healthcare system, while ensuring uninterrupted access to essential medication.

Strategic Impact and Market Opportunity
According to IQVIA (MAT Dec 2024), the total U.S. market for Lenalidomide was valued at approximately USD 2.9 billion, making it one of the highest-value generic launches in recent years. With this approval, Cipla joins a select group of global pharmaceutical manufacturers positioned to make a meaningful impact in the competitive oncology generics landscape.

Umang Vohra, MD & Global CEO, Cipla Ltd, said in a statement:

“The USFDA approval for our Lenalidomide generic is a strategic milestone, not just for Cipla but for global oncology access. This reinforces our capabilities in complex generics and our long-term commitment to enabling affordable cancer care for patients across the world.”

The launch of Cipla’s Lenalidomide capsules in the U.S. is expected to begin in a phased manner, in alignment with previously disclosed confidential settlement terms with the originator.

Regulatory and Technical Highlights:
Product Name: Lenalidomide Capsules (5 mg, 10 mg, 15 mg, 25 mg)

Reference Listed Drug (RLD): Revlimid® (Bristol Myers Squibb)

Indications: Multiple Myeloma (MM), Myelodysplastic Syndromes (MDS), Mantle Cell Lymphoma (MCL), Follicular Lymphoma (FL)

Route of Administration: Oral

ANDA Approval Date: April 12, 2025

Manufacturing Site: Cipla’s USFDA-approved manufacturing facility in Kurkumbh, Maharashtra, India

A Growing Oncology Footprint
This approval follows Cipla’s string of successful oncology filings and launches in the U.S. and EU markets. The company has been steadily expanding its oncology portfolio with targeted therapies and complex injectables, reflecting its strategic pivot from traditional generics to specialty pharmaceuticals.

In addition to Lenalidomide, Cipla continues to strengthen its presence in other critical therapeutic segments such as respiratory, anti-retroviral, and central nervous system (CNS) disorders.