Generic for Alimta Receives Tentative Approval

August 29, 2019 – The U.S. FDA has granted tentative approval to Mylan’s generic for Eli Lilly’s Alimta® (pemetrexed injection). The product is indicated to treat of pleural mesothelioma and non-small cell lung cancer.

In 2017, the FDA granted Eagle Pharma tentative approval for its own generic version of Alimta, known as Pemfexy. Neither Mylan’s nor Eagle’s products have been launched, due to patent protections on the brand name product. The U.S. Court of Appeals upheld these protections in August 2019 when Dr. Reddy's Laboratories and Pfizer challenged Alimta’s patents in an effort to bring alternative salt versions of pemetrexed to the U.S. market.

Alimta's newest indication, for the treatment of metastatic nonsquamous non-small cell lung cancer, was granted in January 2019, and Eli Lilly is in the process of seeking additional approvals that could extend the drug's patent protections. If patent protections continue to be upheld in court, generic versions are unlikely to become available prior to May 2022.