Lupin gets USFDA nod for generic cancer drug Lenalidomide capsules

Lupin has received USFDA approval for generic Lenalidomide capsules in six strengths, adding to competition in the US oncology market for Bristol-Myers Squibb's Revlimid

Global pharmaceutical company Lupin has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Lenalidomide capsules in multiple strengths — 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg.

 

The drug is a generic version of Bristol-Myers Squibb’s blockbuster Revlimid, one of the world’s most prescribed cancer therapies.

 

According to IQVIA data, Revlimid recorded sales of $7.5 billion in the US for the 12 months ending July 2025. Lupin’s capsules will be manufactured at the company’s Pithampur facility in Madhya Pradesh.

 

Lenalidomide is prescribed for adult patients with multiple myeloma in combination with dexamethasone, as maintenance therapy following autologous haematopoietic stem cell transplantation, and for transfusion-dependent anaemia in certain types of myelodysplastic syndromes (MDS). Its approval adds Lupin to the growing list of generics entering the US oncology segment, which has seen increasing competition since Revlimid lost market exclusivity.

 

Industry experts believe the entry of additional generics will accelerate price erosion in the category, expanding access to patients while reshaping revenues for manufacturers. For Lupin, the approval strengthens its US generics portfolio, where it has a strong presence across therapeutic areas.

 

Headquartered in Mumbai, Lupin is among India’s top pharmaceutical exporters and has operations in over 100 countries. Its portfolio spans branded and generic formulations, complex generics, biologics and active pharmaceutical ingredients. The company operates 15 manufacturing facilities and seven R&D centres globally, supported by over 24,000 employees.

 

With oncology continuing to be a key growth driver for global pharmaceutical companies, Lupin’s latest approval positions it to tap into one of the largest cancer therapy markets in the US, while enhancing affordability for patients.