US-based Celgene Corporation has filed a lawsuit against Hyderabad-based Natco Pharma in connection with the latter?s filing of an abbreviated new drug application (Anda) with the US Food and Drug Administration (FDA) seeking approval to market Lenalidomide capsules, used for treatment of cancer. Celgene filed the lawsuit on October 8 in a US district court in New Jersey seeking to prevent Natco from commercialising its product prior to the expiration of certain US patents.
Celgene?s lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Natco?s ANDA for 30 months or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.
Natco?s Lenalidomide capsules are generic versions of Celgene?s Revlimid. Based on information, Natco believes it may be a ?first applicant? to file an ANDA for the generic versions of Revlimid and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.
The company had filed an abbreviated new drug application (ANDA) with the US FDA for approval to market lenalidomide capsules in 5, 10, 15 and 25 mg strengths prior to the expiration of various US patents.
The company notified Celgene that its ANDA requesting approval from the FDA for a generic version of Revlimid contained a paragraph IV certification asserting that various Revlimid patents are invalid, unenforceable and/or not infringed.