Pharmaceutical company Eagle Pharmaceuticals Inc (Nasdaq:EGRX) revealed on Tuesday the receipt of an additional patent for BENDEKA from the US Patent and Trademark Office (USPTO).
The company added that the patent, which has been assigned the number 10,010,533, will expire January 2031. The USPTO has now issued or allowed a total of 15 patents in the BENDEKA family of patents expiring from 2026 to 2033. The newly issued patent will be listed in the US FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) bringing its total Orange Book listed patents for BENDEKA to 13.
Following a Court decision on 8 June 2018, BENDEKA now has Orphan Drug Exclusivity (ODE), under which, the US FDA will not be able to approve any drug applications referencing BENDEKA until the ODE expires in December 2022, according to the company.
Moreover, the company now does not expect generic TREANDA entrants into the market until December 2022, rather than November 2019.
Additionally, Teva Pharmaceutical Industries Ltd is responsible for all US commercial activities for BENDEKA, including promotion and distribution, under a February 2015 exclusive license agreement with the company.
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