Teva Pharmaceuticals announced Monday the launch of its first generic version of Revlimid (lenalidomide) capsules in 5mg, 10mg, 15mg, and 25mg strengths, according to Business Wire.
Christine Baeder, SVP, Chief Operating Officer US Generics, Teva USA, said, “The launch of our first generic version of Revlimid in the U.S. provides patients with another important treatment option for these extremely challenging conditions, demonstrating Teva’s commitment to making complex generic drugs available to the patients who need them.”
“This product adds to our broad generic portfolio of oncology treatments, which accounts for 73% of the essential medicines in this category, as defined by the World Health Organization,” she added.
Teva has the largest portfolio of generic drugs approved by the U.S. Food and Drug Administration (FDA). It develops nearly 550 generic drugs and holds the leading position in first-to-file opportunities. Currently, at least one in 12 generic prescription drugs dispensed in the nation is filled with a Teva product.
Teva has been developing and producing generic medicines to improve people’s lives for more than a century. It is one of the global leaders in generic and specialty medicines. Globally, more than 200 million people take generic medicines developed by Teva.
Apart from developing generic drugs, Teva has significant innovative research and operations in producing specialty and biopharmaceutical products.
Bristol-Myers Squibb, an American multinational pharmaceutical company, manufactures the brand Revlimid. The FDA approved the brand Revlimid in December 2005.
Revlimid had annual sales of $2.3 billion as of December 2021, according to IQVIA data. OQVIA is an American multinational company serving the combined industries of health information technology and clinical research.
Lenalidomide is a prescription drug used for the treatment of multiple myeloma, certain myelodysplastic syndromes, and mantle cell lymphoma. It is not used to treat people with chronic lymphocytic leukemia (CLL).
Lenalidomide is similar to the medicine thalidomide (Contergan, Thalomid), which is also used to treat a number of cancers. Both lenalidomide and thalidomide can cause severe life-threatening birth defects.
In October 2021, Indian-based pharmaceutical company Dr. Reddy’s Laboratories announced the final approval of its Abbreviated New Drug Application (ANDA) for generic lenalidomide capsules from the FDA.
The company said at the time that the FDA approved generic lenalidomide capsules in 2.5 mg and 20 mg strengths, giving tentative approval for 5 mg, 10 mg, 15 mg, and 25 mg strengths. It said, “With this approval, Dr. Reddy’s is eligible for 180 days of generic drug exclusivity for Lenalidomide capsules, 2.5 mg and 20 mg.”
