aibioFennec Pharmaceuticals settles PEDMARK patent litigation with Cipla
Tickers FENC
Under a license agreement, the lawsuit will be dismissed and Cipla will not sell a generic version in the U.S. until September 1, 2033, or earlier under specified circumstances. Each side bears its own costs.
Key facts
- Company
- Fennec Pharmaceuticals Inc. (NASDAQ: FENC)
- News type
- Legal
- Primary source
- FENNEC PHARMACEUTICALS INC. Form 8-K filed March 16, 2026 (SEC EDGAR)
Fennec Pharmaceuticals Inc. settled its patent litigation over a generic version of PEDMARK with Cipla Limited and Cipla USA, Inc., the defendants in the case, according to a Form 8-K filed March 16, 2026. The case is captioned Fennec Pharmaceuticals Inc. v. Cipla Limited and Cipla USA, Inc., C.A. No. 2:23-cv-00123-JKS-MAH, in the U.S. District Court for the District of New Jersey. Fennec is the plaintiff. The company entered into a License Agreement with Cipla on March 16, 2026 to resolve the dispute.
How the dispute started
The filing's background is in the annual report. Cipla filed an abbreviated application, ANDA No. 218028, for a generic version of PEDMARK, sodium thiosulfate solution, with Paragraph IV certifications on two of Fennec's patents. The report lists one patent, licensed from the Oregon Health and Science University, expiring in January 2038, and another, the '728 patent, expiring in July 2039. A Paragraph IV letter dated January 5, 2023 also covered the newly issued '984 patent. Fennec sued the Cipla entities on January 10, 2023. The annual report also says that after a valid Paragraph IV notice, Fennec may bring a patent infringement suit within 45 days.
The settlement terms
The settlement fixes a date for generic competition to PEDMARK in the United States. Under the License Agreement, the lawsuit will be dismissed, each party will bear its own costs, and Cipla has agreed not to enter the U.S. market with its generic sodium thiosulfate product until September 1, 2033, subject to earlier entry under specified circumstances. The 8-K does not describe those circumstances. A press release furnished with the filing repeats the terms and calls the agreement a resolution of the litigation. The 8-K furnishes the release under Item 8.01 and says it is not deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934.
The 8-K describes no payment from Cipla to Fennec and no royalty under the License Agreement, so its only stated economic term is the entry date. It also does not explain why the entry date falls several years before the July 2039 expiry the annual report lists for the '728 patent.
About PEDMARK
According to the press release, PEDMARK is the first and only FDA approved therapy indicated to reduce the risk of ototoxicity associated with cisplatin treatment in pediatric patients one month of age and older. Ototoxicity means hearing damage. The annual report says FDA approval came on September 20, 2022. Orphan drug exclusivity for PEDMARK runs to September 20, 2029, according to the report.
Fennec's European partner is Norgine Pharma UK Limited. In March 2024 Fennec licensed PEDMARQSI, the European name of the product, to Norgine for Europe, Australia and New Zealand. The annual report says Fennec received approximately $43 million in upfront consideration and may receive up to approximately $230 million in additional commercial and regulatory milestones, plus royalties on net sales in the licensed territories.
About the company
In its annual report filed March 26, 2025, Fennec says it was originally formed as Adherex Technologies Inc. and changed its name on September 3, 2014.
The annual report also warns that patent protection for PEDMARK may expire before the company can fully realize its commercial value.
People named in the filings
Chief Financial Officer Robert Andrade signed the 8-K on March 16, 2026.