americanpharmaceuticalreviewAugust 23, 2018
Tag: Eagle Pharmaceuticals , New Patent , BENDEKA
Eagle Pharmaceuticals announced that an additional patent has been issued related to Bendeka by the United States Patent and Trademark Office (USPTO). Patent number 10,052,385 will expire March 2033. The USPTO has now issued or allowed a total of 16 patents in the Bendeka family of patents expiring from 2026 to 2033.
The newly issued patent will be listed in the U.S. Food and Drug Administration’s (FDA) Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) bringing Eagle’s total Orange Book listed patents for Bendeka to 14. Bendeka has Orphan Drug Exclusivity (ODE) until December 2022 as a result of the U.S. District Court for the District of Columbia’s decision issued on June 8, 2018.
"The ODE and growing strength of our intellectual property portfolio may protect the Bendeka franchise well beyond 2022," stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.
Under a February 2015 exclusive license agreement for Bendeka, Teva Pharmaceutical Industries is responsible for all U.S. commercial activities for the product including promotion and distribution.
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