Fennec Pharmaceuticals Announces Settlement Agreement Resolving PEDMARK Patent Litigation

Executive Summary

• Fennec Pharmaceuticals entered into a settlement agreement with Cipla Limited and Cipla USA, ending the lawsuit over Cipra’s generic sodium thiosulfate (PEDMARK®) application.
• Under the settlement, Cipla will not launch its generic product before September 1 2033 (or earlier only under limited circumstances), preserving Fennec’s market exclusivity for at least seven more years.
• Each party will bear its own legal costs; the case will be dismissed.

Key Details

• Parties: Fennec Pharmaceuticals Inc. (NASDAQ:FENC, TSX:FRX) and Cipla Limited / Cipla USA, Inc.
• Legal Reference: Fennec Pharmaceuticals Inc. v. Cipla Limited and Cipla USA, Inc., C.A. No. 2:23‑cv‑00123‑JKS‑MAH (D.N.J.).
• Settlement Terms:
• Lawsuit dismissed with each side paying its own costs.
• Cipla agrees to delay entry of a generic sodium thiosulfate product until Sept 1 2033 (earlier only under specific, undisclosed circumstances).
• Impact on Market: Extends Fennec’s exclusivity period for PEDMARK® in the United States, protecting revenue streams and market share.
• Product Background: PEDMARK® is the sole FDA‑approved therapy to reduce cisplatin‑induced ototoxicity in pediatric patients; approved Sep 2022, with orphan drug exclusivity through 2039.

Notable Quotes

(No direct quotes were provided in the release.)