Lannett Company, Inc. said it entered into a settlement and license agreement with Celgene Corporation that resolves patent infringement litigation in the US related to Celgene’s Thalomid.
“The license agreement permits Lannett to manufacture and market in the U.S. its generic thalidomide product as of August 1, 2019 or earlier under certain circumstances,” said Lannett.
“As mandated by the U.S. Food and Drug Administration (FDA), Thalomid is subject to Risk Evaluation and Mitigation Strategies (REMS) program, which is designed and implemented during the commercialization of a pharmaceutical product to ensure an acceptable risk-to-benefit ratio for products that are known to exhibit specific risks.”
Lannett CEO Arthur Bedrosian said: “I congratulate my staff and colleagues for showing the courage and resolve in successfully tackling such a complex project as thalidomide.
“We believe our thalidomide will be the first entrant in the U.S. generic market.”
Lannett is seeking approval from the FDA of its pending Abbreviated New Drug Application (ANDA) for thalidomide capsules 50 mg, 100 mg, 150 mg and 200 mg, the therapeutic equivalent to the reference listed drug, Thalomid Capsules, 50 mg, 100 mg, 150 mg and 200 mg, of Celgene Corporation.
Subject to FDA approval of Lannett’s ANDA for Thalidomide, the company intends to launch its product under the terms of the license agreement, which are confidential.