Lotus Pharmaceutical Co Ltd (美時化學製藥) on Saturday announced that the company and its affiliate Alvogen Pine Brook LLC reached an agreement with Celgene Corp, settling patent litigation over blood cancer drug Revlimid.
Under the settlement, Lotus and Alvogen are licensed to make and sell “volume-limited amounts of generic lenalidomide in the US,” a Taiwan Stock Exchange filing said.
The companies would market lenalidomide in the US “on a confidential date sometime after the March 2022 date that Celgene previously granted to Natco [Pharma Ltd of India],” the filing said.
The volume-limited shipments would periodically increase by no more than a single-digit percentage until Jan. 31, 2026, at which time Lotus and Alvogen could sell lenalidomide in the US without a volume limitation, it said.
The firms’ ability to sell lenalidomide in the US would be contingent on obtaining approval of an abbreviated new drug application, on which there was a 30-month stay before the settlement, the filing said.
Unlike new drug applications, an abbreviated new drug application submitted to the US Food and Drug Administration for review of a generic drug does not need preclinical and clinical trial data to establish safety and effectiveness.
Lotus is seeking US regulatory approval to market lenalidomide in 2.5mg, 5mg, 10mg, 20mg and 25mg doses, the company said earlier.
Celgene’s blockbuster Revlimid reported global sales of US$9.69 billion and US sales of US$6.47 billion last year, the Summit, New Jersey-based company said.
Lotus posted net income of NT$99.48 million last year, compared with NT$21.79 million in 2017, or earnings per share of NT$0.42, up from NT$0.09 in 2017, while revenue was flat at NT$6.43 billion.
The company’s cumulative revenue in the first two months of the year totaled NT$1.6 billion, up 58.29 percent from a year earlier, company data showed.
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