MSD, Pfizer try to stop three Steglatro generics
Merck Sharp & Dohme (MSD) and Pfizer have filed three complaints with the Delaware district court to attempt to shut down proposed generics of Steglatro (ertugliflozin)—a diabetes treatment that Pfizer licences to MSD.
The lawsuits, filed on Thursday, March 23, look to shut down proposed generics from Hetero Labs, Zenara Pharma, and Aurobindo Pharma which hoped to launch prior to the expiration of a key patent.
The patent in question, US patent number 8,080,580, covers “Dioxa-bicyclo [3.2.1] octane-2,3,4-triol derivatives” which is currently assigned to Pfizer.
Both MSD and Pfizer claim that the three generic drug makers intend to market and sell their generics following the Food and Drug Administration’s (FDA) approval of their abbreviated new drug application (ANDA).
The three lawsuits ask the Delaware court: To rule that the companies proposed generics infringe the ‘580 patent; to ensure that the generics are sold after the expiration of the patent; to file a preliminary injunction immediately preventing the potential sale of the generics.
Steglatro is indicated to improve glycemic control in adults with type 2 diabetes in conjunction with diet and exercise. The ‘580 patent was issued on December 20, 2011, with Pfizer as the assignee.
According to the MSD’s 2020 annual report, Steglatro’s patent portfolio is set to expire in the US in 2031 and in the EU in 2029.
MSD also recently teamed up with AstraZeneca to file a pair of lawsuits against MSN and Sandoz in a bid to stop their planned generics of leukaemia treatment Calquence (acalabrutinib).
The two complaints said that the Calquence generics infringed on six patents related to blockbuster cancer drug which was first approved by the FDA five years ago.
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