The three new patents will be listed in the Food and Drug Administration's (FDA) Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the Orange Book, according to a company press release. In addition, the FDA previously granted Orphan Drug Designation to Bendeka. Eagle Pharmaceutical is also seeking Orphan Drug Exclusivity for Bendeka, which would extend it through December 2022.
The new patents, Nos. 9,579,397, 9,579,398 and 9,579,399, expire March 2033. The expiration dates of Bendeka patents range from 2026 to 2033. Of the 14 patents, only one has been challenged. Patent number 8,791,270 faced challenges by several companies in the U.S. District Court for the District of Delaware and the USPTO Patent Trial and Appeal Board (PTAB). The patent's validity was confirmed, according to the release.
“We continue to build the strength of our intellectual property portfolio protecting Bendeka,” Eagle Pharmaceuticals CEO Scott Tarriff said in the release. "We see significant value in Bendeka well beyond 2020."
Bendeka was approved for treatment of chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin lymphoma (NHL) in December 2015. The medication is applied in an intravenous infusion for six or eight treatment cycles.