Teva Announces Launch of a First Generic Version of Revlimid (lenalidomide capsules), in the U.S.

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. announced the launch of a first generic version of Revlimid (lenalidomide capsules), in 5mg, 10mg, 15mg, and 25mg strengths, in the United States.

Teva’s Lenalidomide capsules are a prescription medicine used in adults for the treatment of (1) multiple myeloma in combination with the medicine dexamethasone, (2) certain myelodysplastic syndromes, and (3) mantle cell lymphoma following specific prior treatment. Please see the below “What are lenalidomide capsules?” section for more information.

“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,” said Christine Baeder, SVP, Chief Operating Officer US Generics, Teva USA. “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.”

With nearly 550 generic medicines available, Teva has the largest portfolio of FDA-approved generic products on the market, and holds the leading position in first-to-file opportunities, with approximately 100 pending first-to-files in the U.S. Currently, 1 in 12 generic prescriptions dispensed in the U.S. is filled with a Teva generic product.

Revlimid had annual sales of $2.3 billion as of December 2021, according to IQVIA data.

What are lenalidomide capsules? Lenalidomide capsules are a prescription medicine, used to treat adults with:

  • multiple myeloma (MM)
    • in combination with the medicine dexamethasone
  • a condition called myelodysplastic syndromes (MDS). Lenalidomide capsules are for the type of MDS with a chromosome problem where part of chromosome 5 is missing. This type of MDS is known as deletion 5q MDS. People with this type of MDS may have low red blood cell counts that require treatment with blood transfusions.
  • mantle cell lymphoma (MCL) when the disease comes back or becomes worse after treatment with 2 prior medicines, one of which included bortezomib. MCL is a cancer of a type of white blood cell called lymphocytes that are in the lymph nodes.

Lenalidomide capsules should not be used to treat people who have chronic lymphocytic leukemia (CLL) unless they are participants in a controlled clinical trial.

It is not known if lenalidomide capsules are safe and effective in children.

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