Eagle Pharmaceuticals, Inc. announced today that the U.S. District Court for the District of Columbia has issued a decision requiring the FDA to grant seven years of orphan drug exclusivity (ODE) in the U.S., for Bendeka (bendamustine hydrochloride injection, or bendamustine HCI), a liquid, low-volume (50 mL) and short-time 10-minute infusion formulation of bendamustine hydrochloride.

As a result of the court’s decision, the FDA will not be able to approve any drug applications referencing Bendeka until the orphan drug exclusivity expires in December 2022. The company now does not expect generic Treanda’s entrance into the market until 2022, rather than November 2019.

“We are delighted with the court’s decision to grant orphan drug exclusivity for Bendeka, further extending the longevity of this important product,” said Scott Tarriff, chief executive officer. “With 13 Orange Book listed patents extending from 2026 through 2033, and additional pending patent applications, the market protection for Bendeka is likely to be intact for many years. We also believe it will provide for continued profitability and building long-term value for Eagle.”

Orphan drug exclusivity is granted by the FDA Office of Orphan Products Development to drugs or biologics that treat rare diseases or conditions affecting fewer than 200,000 patients in the U.S. The designation typically provides the drug developer with a seven-year period of U.S. marketing exclusivity upon approval, bars FDA from approving any other application (ANDA, 505(b)(2) or “full” NDA or BLA) for the same drug for the same orphan disease, and offers certain financial incentives that can help support its development.

(Source: Eagle Pharmaceuticals, Inc.)