Eagle Pharmaceuticals Inc. has settled a patent dispute with Eli Lilly and Co. that will allow the launch of Eagle's medication Pemfexy in 2022.
Pemfexy is a branded alternative therapy to Lilly's Alimta, which is no longer subject to a patent. Alimta is approved in combination with Merck & Co. Inc.'s Keytruda and platinum chemotherapy as an initial treatment for nonsquamous non-small cell lung cancer with a certain gene mutation that has spread.
A number of companies, including Eagle, are seeking to manufacture copies of the drug, and Lilly has filed several patent disputes to protect the drug from the emerging competitors.
Eagle and Lilly have now agreed to settle all claims against each other, allowing Pemfexy to enter the market as of Feb. 1, 2022. Full, unrestricted entry will be allowed April 1, 2022.
Pemfexy was granted tentative approval from the U.S. Food and Drug Administration on Oct. 27, 2017, with final approval subject to a resolution of the patent dispute with Lilly.
Woodcliff Lake, N.J.-based Eagle develops injectable products in critical care and cancer treatment in the U.S.