> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Companies Weigh-in on Bendeka Exclusivity
- URL: https://www.fdaweb.com/companies-weigh-in-on-bendeka-exclusivity/
- Published: 2018-10-23T12:00:00.000Z
- Updated: 2026-09-15T00:39:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142650

Several companies have responded to an FDA request for comment on issues surrounding orphan drug exclusivity for Eagle Pharmaceuticals’ Bendeka (bendamustine hydrochloride) in light of a federal court order reversing an FDA decision that Bendeka was not entitled to orphan drug exclusivity because it was not clinically superior to existing drugs. [Comments](https://www.regulations.gov/document?D=FDA-2018-N-3773-0015&ref=fdaweb.com) submitted by Meitheal Pharmaceuticals and Pharmascience, Inc., say the federal court’s order construed the statute to compel a grant of orphan exclusivity upon approval of a designated drug without requiring a showing of clinical superiority. “Absent the clinical superiority requirement,” the letter says, “FDA’s regulations render every subsequent drug containing the same active moiety not approvable due to an existing drug’s orphan drug exclusivity. Clearly, the clinical superiority requirement cannot be separated from the regulations, as that would render the entire regulatory scheme unworkable.”

The companies say that because Bendeka has exclusivity, FDA should deem the earlier-filed Treanda and its generics as outside the scope of Bendeka’s exclusivity as a matter of law. “Of course,” they say, “Eagle Pharmaceuticals would like to enjoy an all-encompassing, compound patent-type exclusivity for seven years in the bendamustine market. But there is no justification, in either law or policy, to convert Bendeka’s orphan drug exclusivity into a broader same-active-moiety exclusivity for seven years.

Mylan [says](https://www.regulations.gov/document?D=FDA-2018-N-3773-0019&ref=fdaweb.com) FDA should consider its clinical superiority regulations to be inseverable from the remaining orphan drug regulations. It notes that the agency has argued that the portions of the orphan drug regulations invalidated by the court order are critical to the regulatory scheme that existed before the court’s order and are irrevocably intertwined with the remaining provisions of the regulations.

The [comment](https://www.regulations.gov/document?D=FDA-2018-N-3773-0018&ref=fdaweb.com) submitted by Fresenius Kabi USA says that if FDA prevails in its appeal of the court order, Bendeka will not be entitled to any exclusivity and thus the agency should defer issuing any decision that would broaden the scope of Bendeka’s exclusivity beyond that specific product until after the appeal of the district court ruling is resolved.

Jenner & Block, writing on behalf of two ANDA applicants, [says](10-10-18%20harassment.docx) that in the event that Bendeka’s orphan drug exclusivity extends to applications referencing Treanda, the current approval status of such applications should not matter.