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# Bendeka Exclusivity Covers all Bendamustine Drugs: FDA
- URL: https://www.fdaweb.com/bendeka-exclusivity-covers-all-bendamustine-drugs-fda/
- Published: 2019-02-28T12:00:00.000Z
- Updated: 2026-09-15T01:08:47.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143496

FDA says it has concluded that the scope of exclusivity ordered by a federal court for Eagle’s leukemia drug Bendeka extends to all applications containing the same active moiety as Bendeka, bendamustine, and bars approval of any application containing bendamustine for any exclusivity-protected indication starting on the 12/7/15 date of Bendeka’s approval and running for seven years until 12/7/22, unless a sponsor establishes clinical superiority or an exception to exclusivity applies. The determination is in a 12/20 agency [letter](https://www.regulations.gov/contentStreamer?documentId=FDA-2018-N-3773-0024&attachmentNumber=1&contentType=pdf&ref=fdaweb.com) to applicants for certain products containing bendamustine.

FDA had denied Eagle’s request for orphan drug exclusivity, saying the company had not demonstrated that Bendeka was clinically superior to Cephalon’s Treanda (bendamustine) injection. But the federal court held that Eagle was entitled to exclusivity under the plain language of the law.

“Because the district court’s decision has been appealed, it is possible that the agency’s position will prevail upon appeal, in which case Eagle would not have any orphan drug exclusivity,” the letter says. “Thus, the current actions FDA is taking for affected applications may need to be revised based on the outcome of the appeal.”