FDA Denies Seven Year Orphan Drug Exclusivity for BENDEKA

Eagle Pharmaceuticals has announced that the U.S. Food and Drug Administration (FDA) has denied Eagle’s request for seven years of orphan drug exclusivity 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. BENDEKA was approved in December 2015 for the treatment of patients with chronic lymphocytic leukemia (CLL) and for the treatment of patients with indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. Efficacy in CLL relative to first-line therapies other than chlorambucil has not been established.

Eagle believes that the FDA’s decision is incorrect, and that BENDEKA was automatically entitled to orphan drug exclusivity for CLL and indolent B-cell NHL upon the drug’s December 2015 approval. The FDA previously granted orphan drug designation for BENDEKA for both indications. Eagle is evaluating all options to challenge the FDA’s decision.

Orphan drug designation is granted by the FDA Office of Orphan Products Development to novel 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, as well as certain financial incentives that can help support its development.

The FDA currently requires sponsors of certain orphan designated drugs to make a “clinical superiority” demonstration as a condition to obtaining the seven-year exclusivity period upon approval. The FDA applies this requirement whenever the FDA has previously approved another drug of the same active moiety for the same indication.

In September 2014, DepoMed, Inc. (DepoMed) prevailed in litigation in federal district court in the District of Columbia, challenging the FDA’s application of this clinical superiority demonstration requirement to its orphan-designated drug product, GRALISETM. DepoMed argued that the requirement violates the Orphan Drug Act, which automatically confers seven years of marketing exclusivity on orphan designated products upon approval. District Judge Ketanji Brown Jackson agreed with DepoMed’s position, and ordered the FDA to recognize orphan drug exclusivity for GRALISE without requiring proof of “clinical superiority.” While the FDA granted orphan drug exclusivity for GRALISE without a clinical superiority demonstration, it has continued to require the clinical superiority demonstration for other orphan designated drugs, such as BENDEKA.

Eagle believes that the FDA’s rejection of orphan drug exclusivity for BENDEKA closely mirrors the decision that Judge Jackson overturned in the DepoMed litigation, and Eagle is evaluating all options to obtain a reversal of the FDA’s BENDEKA decision at this time.

“We are disappointed with the agency’s decision regarding orphan drug exclusivity for BENDEKA, which we believe to be incorrect,” said Scott Tarriff, President and Chief Executive Officer. “With six 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. These patents will continue to be in effect beyond the seven years of exclusivity that would have been provided had the orphan drug exclusivity been granted. We believe the FDA’s decision will have little to no impact on our bendamustine HCI business in the near term,” concluded Tariff.

The following table lists the patents for liquid bendamustine hydrochloride (HCl) formulations:




U.S. Patent No.


Patent Expiration




8,791,270*PED (Owned by Teva Pharmaceutical Industries, Ltd.)















Under a February 2015 exclusive license agreement for BENDEKA, a subsidiary of Teva Pharmaceutical Industries, Ltd. is responsible for all U.S. commercial activities for the product including promotion and distribution. BENDEKA was launched by Teva in late January 2016. As previously announced, Eagle receives a 20% royalty on Teva’s sales of BENDEKA.

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