- Bendeka has Orphan Drug Exclusivity until Dec. 2022
- Company does not expect generic entrants of previous version of Bendeka until Dec. 2022
- Teva is responsible for all US commercial activity involving Bendeka
Eagle Pharmaceuticals, Inc. (Nasdaq:EGRX) (“Eagle” or “the Company”) today announced that an additional patent has been issued related to Bendeka by the United States Patent and Trademark Office (USPTO). Patent 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 company and its partner, Teva Pharma, received additional good news in June of 2018 when a District Court ruled in favor of granting Orphan Drug Exclusivity to Bendeka for 7 years of exclusivity from the date of the drug’s approval in December 2015. The FDA will not be able to approve any drug applications referencing Bendeka until the ODE expires in December 2022. Moreover, the Company now does not expect generic Treanda entrants into the market until December 2022, rather than November 2019.
Treanda is a previous generation version of Bendeka. Bendeka is the rapid infusion version of bendamustine HCI. The drug is for the treatment of patients with chronic lymphocytic leukemia (CLL) and patients with indolent B-cell non-Hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.
“We believe that with the recent positive orphan drug exclusivity decision and the strength of our intellectual property portfolio, BENDEKA has longevity well beyond 2022,” stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.
Under a February 2015 exclusive license agreement for BENDEKA, Teva Pharmaceutical Industries, Ltd. is responsible for all U.S. commercial activities for the product including promotion and distribution.