2 November 2017 - - US-based generic pharmaceutical products company Lannett company, Inc. (NYSE: LCI) has entered into a settlement and license agreement with Celgene Corp. that resolves patent infringement litigation in the US related to Celgene's Thalomid, the company said.

The license agreement permits Lannett to manufacture and market in the US its generic thalidomide product as of August 1, 2019 or earlier under certain circumstances.

As mandated by the US Food and Drug Administration, Thalomid is subject to Risk Evaluation and Mitigation Strategies program, which is designed and implemented during the commercialisation of a pharmaceutical product to ensure an acceptable risk-to-benefit ratio for products that are known to exhibit specific risks.

Lannett is seeking approval from the FDA of its pending Abbreviated New Drug Application for thalidomide capsules 50 mg, 100 mg, 150 mg and 200 mg, the therapeutic equivalent to the reference listed drug, ThalomidCapsules, 50 mg, 100 mg, 150 mg and 200 mg, of Celgene Corp.

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.

Lannett Co, founded in 1942, develops, manufactures, packages, markets and distributes generic pharmaceutical products for a wide range of medical indications.