USA – Teva has launched its generic version of Bristol Myers Squibb’s Revlimid (lenalidomide) in the United States on Monday, making it the country’s first generic version of the cancer treatment.

Teva will offer Lenalidomide capsules in 5 mg, 10 mg, 15 mg, and 25 mg strengths for the treatment of multiple myeloma in combination with dexamethasone, certain myelodysplastic syndromes, and mantle cell lymphoma following specific prior treatment, according to the company.

The company did not specify how much it would charge.

Sandoz and Stada Arzneimittel announced last month that generic versions of Revlimid are now available in Europe. Teva is now the first company to do the same in the United States.

Many other companies, including Indian firms Natco Pharma, Sun Pharma, Zydus Cadila, Cipla, and Dr. Reddy’s Laboratories, are planning to launch Revlimid generics in the United States this year.

As a result of their patent challenges, these companies reached limited launch agreements with BMS. Natco Pharma, which received FDA approval for its generic in May of last year, agreed to postpone its launch until March of this year.

Then, in the first month, Natco and its U.S. marketing partner Arrow will only produce a small amount—a mid-single-digit percentage of Revlimid’s monthly volume.

That percentage rises over time, reaching 33% of Revlimid’s volume by March 2025. The restrictions will then expire on January 31, 2026.

The settlements came after Revlimid’s former manufacturer Celgene successfully defended itself against a patent challenge from Dr. Reddy’s.

The launch provides patients with another important treatment option for these extremely challenging conditions…[and] adds to our broad generic portfolio of oncology treatments.”

Christine Baeder, chief operating officer for Teva’s US generics business.

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Celgene was able to extend its exclusivity and make advantageous deals with generics makers as a result of the decision, which will help slow the erosion of Revlimid’s sales.

The introduction of generics usually results in price reductions. However, limited-quantity deals like these will have less of an impact on prices.

In late 2019, Bristol Myers Squibb acquired Revlimid as part of its US$74 billion acquisition of Celgene. The drug made US$3.3 billion in sales in the fourth quarter of 2021 and US$12.8 billion in total revenue last year.

Other treatments that Bristol Myers Squibb gained as a result of its Celgene buyout include Breyanzi (lisocabtagene maraleucel), a CD19-directed CAR-T therapy approved by the FDA to treat patients with large B-cell lymphoma in the third-line or later setting.

It also acquired the CAR-T therapy Abecma (idecabtagene vicleucel), which targets BCMA, and is cleared in the US to treat multiple myeloma in patients who have received at least four prior lines of therapy.

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