Fennec Pharmaceuticals v. Cipla: Consent Judgment Over PEDMARK® Patents
Fennec Pharmaceuticals and Oregon Health & Science University filed suit against Cipla Limited and CIPLA USA in the District of New Jersey, asserting three patents covering PEDMARK® (sodium thiosulfate injection) against Cipla's ANDA filing. The case resolved by consent judgment after 1,175 days, with the court retaining jurisdiction to enforce a disclosed License Agreement.
ANDA Infringement Action Over Ototoxicity Drug Ends in Consent Judgment
On January 10, 2023, Fennec Pharmaceuticals, Inc. and Oregon Health and Science University filed a patent infringement action in the U.S. District Court for the District of New Jersey against Cipla Limited and CIPLA USA, Inc. The suit asserted three U.S. patents — US12311026B2, US11964018B2, and US11617793B2 — covering PEDMARK® (sodium thiosulfate injection), a formulation containing approximately 0.5 M aqueous sodium thiosulfate and 0.004 M boric acid indicated for the reduction of cisplatin-induced ototoxicity.
The case was triggered by Cipla's submission of Abbreviated New Drug Application No. 218028 under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) — a Paragraph IV certification — which constitutes a statutory act of infringement under Hatch-Waxman. The case closed on March 30, 2026, with the court entering a consent judgment. The recorded basis of termination is Consent Judgment; the docket order dismisses all claims without prejudice and references a License Agreement between the parties, with the court expressly retaining jurisdiction to enforce both the consent judgment and that agreement. Each party bears its own costs and attorneys' fees.
At 1,175 days, the duration extends beyond the standard 30-month Hatch-Waxman stay, suggesting the parties litigated substantively before reaching resolution. The consent judgment permits final approval of Cipla's ANDA on the date it is entered, a provision that typically signals a negotiated commercial arrangement. The specific terms of the License Agreement referenced in the order are not disclosed in the available public record.
See Complete Case & Patent Analysis →Filing to Consent Judgment in 1175 days
1,175 days from filing to consent judgment — typical Hatch-Waxman ANDA cases often resolve within 30-month stay windows
US12311026B2, US11964018B2 & US11617793B2 — PEDMARK® Sodium Thiosulfate Injection
Any pharmaceutical company or ANDA applicant developing a sodium thiosulfate injection product — whether for ototoxicity, oncology supportive care, or adjacent indications — should conduct an FTO analysis against all three PEDMARK® patents before filing. The consent judgment resolves only Cipla's position; all three patents remain active and enforceable against third parties. Given the continuation-heavy portfolio structure, adjacent formulation changes may not be sufficient to avoid infringement without a thorough claim-level analysis.
Official order — verbatim text
The consent judgment order dismisses all claims without prejudice while simultaneously entering a binding court judgment — an internally complex structure characteristic of Hatch-Waxman ANDA resolutions. The court's retained jurisdiction over both the consent judgment and the referenced License Agreement gives the order ongoing legal force beyond the dismissal of claims. Cipla's ANDA approval is expressly unlocked at the moment of entry, which is the operative commercial event in this resolution.
Consent judgment: what the agreed resolution means for both parties
A court-entered judgment on agreed terms ends the litigation
A consent judgment is a binding, court-entered judgment reflecting terms agreed by the parties. Unlike a voluntary dismissal, it carries the full legal weight of a judicial judgment and can be enforced by the court. Here, the court expressly retained jurisdiction over both parties to enforce the consent judgment, the referenced License Agreement, and any third-party claims arising from it — an unusually broad retention clause.
Court-entered, binding & enforceablePlaintiffs secure court-enforceable protection and a License Agreement
For Fennec Pharmaceuticals and Oregon Health & Science University, the consent judgment provides a court-enforced mechanism to govern Cipla's path to market. The court's retained jurisdiction over the License Agreement gives plaintiffs a direct enforcement avenue without needing to refile. The specific commercial terms of the License Agreement are not disclosed in the available public record.
Retained enforcement jurisdictionCipla's ANDA gains a defined route to market entry
The consent judgment expressly provides that final approval of Cipla's ANDA No. 218028 may be granted on the date the judgment is entered. This provision ends the 30-month Hatch-Waxman litigation hold and gives Cipla a clear regulatory trigger for launch. The terms governing the scope of that commercialisation are set out in the License Agreement, the specifics of which are not publicly disclosed.
ANDA approval unlocked at entryPrecedent for generic sodium thiosulfate competition under licence
The consent judgment signals that at least one generic manufacturer has negotiated a licensed pathway to market for sodium thiosulfate injection. Companies monitoring the ototoxicity treatment space — particularly other potential ANDA filers — should note that the court's retained jurisdiction over third-party claims under the License Agreement may affect their own freedom-to-operate analysis. The three asserted patents remain in force.
Licensed generic entry signalledFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | Fennec Pharmaceuticals, Inc. | Company | /Search in Eureka ↗ |
| Co-Plaintiff | Oregon Health and Science University | Company | Search in Eureka ↗ |
| Defendant | Cipla Limited | Individual | /Search in Eureka ↗ |
| Co-Defendant | CIPLA USA, Inc. | Company | Search in Eureka ↗ |
| Plaintiff counsel | CHAD RAFETTO | Attorney | Counsel for Fennec Pharmaceuticals, Inc.Search in Eureka ↗ |
| Plaintiff counsel | ELIZA P. O'CONNOR | Attorney | Counsel for Fennec Pharmaceuticals, Inc.Search in Eureka ↗ |
| Plaintiff counsel | John D. Tortorella | Attorney | Counsel for Fennec Pharmaceuticals, Inc.Search in Eureka ↗ |
| Plaintiff counsel | Kevin Harry Marino | Attorney | Counsel for Fennec Pharmaceuticals, Inc.Search in Eureka ↗ |
| Plaintiff law firm | Marino Tortorella & Boyle, PC | Law Firm | Representing Fennec Pharmaceuticals, Inc.Search in Eureka ↗ |
| Defendant counsel | Loly G. Tor | Attorney | Counsel for Cipla LimitedSearch in Eureka ↗ |
| Defendant counsel | Peter Louis Giunta | Attorney | Counsel for Cipla LimitedSearch in Eureka ↗ |
| Defendant counsel | WILLIAM E. ANTONIDES , III | Attorney | Counsel for Cipla LimitedSearch in Eureka ↗ |
| Defendant law firm | K&L Gates, LLP | Law Firm | Representing Cipla LimitedSearch in Eureka ↗ |
| Presiding judge | Judge N/A | Judge | New Jersey District CourtSearch in Eureka ↗ |
R&D signals in the sodium thiosulfate ototoxicity patent space
Forward-looking patent and R&D intelligence for companies active in cisplatin-induced ototoxicity treatment, sodium thiosulfate formulation, and oncology supportive care.
Fennec's continuation strategy suggests further PEDMARK® patent filings ahead
The three asserted patents share staggered application numbers — US18/606860, US17/992715, and US17/871825 — consistent with an active continuation filing strategy. This pattern suggests Fennec and OHSU may be pursuing additional claims covering formulation variants, dosing methods, or manufacturing processes. Monitoring Fennec's pending applications is essential for any company planning an ANDA or biosimilar-adjacent development programme.
Active continuation filing patternCisplatin ototoxicity protection is an emerging IP battleground in paediatric oncology
PEDMARK® is the first FDA-approved agent specifically for cisplatin-induced ototoxicity in children. Growing paediatric oncology pipelines and rising cisplatin use globally suggest increasing R&D interest in otoprotective agents. Patent filings around alternative thiosulfate formulations, administration routes, and combination therapies are likely to accelerate — creating both freedom-to-operate challenges and white-space opportunities for innovative developers.
Growing paediatric oncology IP spaceCipla's ANDA filing reveals strategic intent in oncology supportive care
Cipla's submission of ANDA No. 218028 for a sodium thiosulfate injection demonstrates deliberate expansion into oncology supportive care generics. Cipla's broader US patent portfolio and ANDA filing history in specialty injectable drugs warrants monitoring. The consent judgment's licence structure suggests Cipla has secured a commercial pathway — other generic entrants should assess whether that agreement affects the landscape for subsequent challengers.
Cipla injectable oncology expansionAdjacent formulation and delivery innovations remain largely unclaimed
The PEDMARK® patents focus on a specific aqueous formulation with defined thiosulfate and boric acid concentrations. Alternative delivery mechanisms — such as liposomal encapsulation, sustained-release injectables, or co-formulation with other otoprotective agents — may represent white space not covered by the current patent cluster. R&D teams exploring novel formulations for cisplatin ototoxicity should map these adjacencies before investing in development.
Formulation white space opportunitySimilar Hatch-Waxman ANDA patent cases in the District of New Jersey
Explore comparable Hatch-Waxman infringement actions asserting pharmaceutical formulation patents resolved by consent judgment in the District of New Jersey.
What this case signals for the PEDMARK® and Hatch-Waxman IP landscape
A consent judgment with retained jurisdiction and a disclosed-but-undisclosed License Agreement carries meaningful competitive intelligence for the ototoxicity drug space.
Three active patents still enforce PEDMARK®'s formulation — monitor expiry dates
US12311026B2, US11964018B2, and US11617793B2 all remain in force following the consent judgment. Any company developing or marketing a sodium thiosulfate injection formulation comparable to PEDMARK® faces live infringement risk. An FTO analysis against all three patents is essential before ANDA submission or product launch.
Court-retained jurisdiction over the License Agreement is a rare and powerful clause
The court's express retention of jurisdiction to enforce the License Agreement and to hear third-party claims arising from it is an unusually broad provision. Future ANDA filers or licensees in this space may find themselves subject to this court's oversight, even if not original parties to this litigation.
Fennec v Cipla — key questions answered
Fennec Pharmaceuticals and Oregon Health and Science University asserted three patents: US12311026B2, US11964018B2, and US11617793B2. All three cover PEDMARK® (sodium thiosulfate injection), a formulation containing approximately 0.5 M aqueous sodium thiosulfate and 0.004 M boric acid used to reduce cisplatin-induced ototoxicity in paediatric patients.
The case ended with a consent judgment entered on March 30, 2026 — the recorded basis of termination. The order dismisses all claims without prejudice, permits final approval of Cipla's ANDA No. 218028 on the date of entry, and requires each party to bear its own costs. The court retained jurisdiction to enforce the consent judgment and a referenced License Agreement. The specific terms of that agreement are not disclosed in the available public record.
PEDMARK® is an FDA-approved injectable formulation of sodium thiosulfate (approximately 0.5 M) with boric acid (approximately 0.004 M), indicated for reducing cisplatin-induced hearing loss in paediatric patients. Cipla filed ANDA No. 218028 with a Paragraph IV certification — a statutory challenge to the listed patents — which triggered the infringement action under the Hatch-Waxman Act.
The order expressly retains jurisdiction over both parties and over any third-party claims relating to the License Agreement. This is an unusually broad retention clause: it means disputes about the agreement's interpretation or enforcement — including by third parties — remain before the New Jersey District Court without the need to refile. The specific terms of the License Agreement are not disclosed in the available public record.
Yes. The consent judgment does not adjudicate validity or invalidity of US12311026B2, US11964018B2, or US11617793B2. All three patents remain in force and enforceable against third parties who were not parties to this action. Any subsequent ANDA filer or company commercialising a sodium thiosulfate injection product would need to independently assess its freedom to operate against the full patent cluster.
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