Fennec Pharmaceuticals, Inc. et al. v. Cipla Limited et al.
Infringement action filed 10 Jan 2023 in the United States District Court for the District of New Jersey and closed 30 Mar 2026, with 3 patents asserted. Recorded basis of termination: consent judgment.
Case record
- Patents involved
- US12311026B2US11964018B2US11617793B2
- Case no.
- 2:23-cv-00123
- Verdict cause
- Infringement action
- Court
- D.N.J.
- Court level
- District Court
- Case region
- New Jersey
- Chief judge
- None recorded
- Trial level
- First instance
- Filed – Closed
- 10 Jan 2023 – 30 Mar 2026
- Duration
- 1175 days
- Basis of termination
- Consent Judgment
- Products & marks
- PEDMARK® (sodium thiosulfate injection) contains about 0.5 M aqueous sodium thiosulfate and about 0.004 M boric acid
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Therapeutic uses for sodium thiosulfate formulations
Described herein is anhydrous sodium thiosulfate, methods for synthesizing anhydrous sodium thiosulfate, pharmaceutical compositions thereof, and methods of treating ototoxicity. Anhydrous sodium thiosulfate is synthesized from sodium sulfite, sulfur, and cetylpyridinium chloride. The anhydrous sodium thiosulfate is formulated into a pharmaceutical composition comprising a buffer and solvent. These compositions are useful for eliminating or reducing ototoxicity in pediatric patients receiving platinum-based chemotherapeutics.
- Legal status
- Active
- Granted
- 27 May 2025
- Earliest priority
- 3 Jul 2018
- Est. expiry
- 1 Jul 2039
- Validity challenges
- None recorded
- Licences recorded
- None recorded
- Inventors
- SMITH, ALEXANDER · RAYKOV, ROSTISLAV CHRISTOV
- Classification
- A61K9/00A61K9/08A61K33/04A61K33/243A61K47/02A61K47/18A61K47/20
- Prosecution counsel
- KNOWLES INTELLECTUAL PROPERTY STRATEGIES, LLC
- Examiner
- LAZARO, DOMINIC
Therapeutic uses for sodium thiosulfate formulations
Described herein is anhydrous sodium thiosulfate, methods for synthesizing anhydrous sodium thiosulfate, pharmaceutical compositions thereof, and methods of treating ototoxicity. Anhydrous sodium thiosulfate is synthesized from sodium sulfite, sulfur, and cetylpyridinium chloride. The anhydrous sodium thiosulfate is formulated into a pharmaceutical composition comprising a buffer and solvent. These compositions are useful for eliminating or reducing ototoxicity in pediatric patients receiving platinum-based chemotherapeutics.
- Legal status
- Active
- Granted
- 23 Apr 2024
- Earliest priority
- 3 Jul 2018
- Est. expiry
- 1 Jul 2039
- Validity challenges
- None recorded
- Licences recorded
- None recorded
- Inventors
- SMITH, ALEXANDER
- Classification
- A61K47/20A61K9/00A61K9/08A61K33/04A61K33/243A61K47/02A61K47/18
- Prosecution counsel
- Knowles Intellectual Property Strategies, LLC
- Examiner
- LAZARO, DOMINIC
Also asserted in this case
1 moreThe docket lists 3 asserted patents. Full bibliographic detail, drawings and prosecution history for the remaining asserted patent are one query away in Eureka.
Parties of record
Fennec Pharmaceuticals, Inc.
- Core tech
- A61K9/00A61K9/08A61K33/04A61K33/243
- Counsel
- Chad Rafetto · Eliza P. O’Connor · John D. Tortorella · Kevin Harry Marino
- Firm
- Marino Tortorella & Boyle, PC
- Also named
- Oregon Health and Science University
Cipla Limited
- Core tech
- Not recorded
- Counsel
- Loly G. Tor · Peter Louis Giunta · William E. Antonides III
- Firm
- K&L Gates, LLP
- Also named
- CIPLA USA, Inc.
Counsel of record
| Attorney | For | Role |
|---|---|---|
| Chad Rafetto | Fennec Pharmaceuticals, Inc. | Plaintiff |
| Eliza P. O’Connor | Fennec Pharmaceuticals, Inc. | Plaintiff |
| John D. Tortorella | Fennec Pharmaceuticals, Inc. | Plaintiff |
| Kevin Harry Marino | Fennec Pharmaceuticals, Inc. | Plaintiff |
| Loly G. Tor | Cipla Limited | Defendant |
| Peter Louis Giunta | Cipla Limited | Defendant |
| William E. Antonides III | Cipla Limited | Defendant |
Basis of termination
From the record · verbatim“IT IS HEREBY ORDERED, DECREED, and ADJUDGED as follows: 1. The Court has jurisdiction over Fennec and Cipla and the subject matter of this litigation. 2. All claims in this Action are hereby dismissed without prejudice. 3. Each party shall bear its own costs and attorneys’ fees. 4. This Court shall retain jurisdiction over Cipla and Fennec for the purpose of enforcing the terms of this Consent Judgment and Injunction and over any matters related to or arising from the interpretation or enforcement of the License Agreement or any legal or equitable claim concerning the License Agreement by any third party. 5. Final Approval of Cipla’s Abbreviated New Drug Application No. 218028 under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) may be granted on the date that this Consent Judgment is entered.”
Case 2:23-cv-00123 · D.N.J. · closed 30 March 2026
Related cases
Three questions this record usually leads to. Each one runs against the full litigation and patent corpus, and cites what it finds.
Frequently asked questions
What is case 2:23-cv-00123?
2:23-cv-00123 is a patent infringement action brought by Fennec Pharmaceuticals, Inc. against Cipla Limited, filed on 10 Jan 2023 in the United States District Court for the District of New Jersey. The case closed on 30 March 2026.
Which patents were asserted in 2:23-cv-00123?
US12311026B2 (“Therapeutic uses for sodium thiosulfate formulations”), assigned to FENNEC PHARMACEUTICALS, INC., currently active; US11964018B2 (“Therapeutic uses for sodium thiosulfate formulations”), assigned to FENNEC PHARMACEUTICALS, INC., currently active; US11617793B2 (“Anhydrous sodium thiosulfate and formulations thereof”), assigned to FENNEC PHARMACEUTICALS, INC.. The record also lists PEDMARK® (sodium thiosulfate injection) contains about 0.5 M aqueous sodium thiosulfate and about 0.004 M boric acid.
How was case 2:23-cv-00123 terminated?
The recorded basis of termination is consent judgment. The termination text reads: “IT IS HEREBY ORDERED, DECREED, and ADJUDGED as follows: 1. The Court has jurisdiction over Fennec and Cipla and the subject matter of this litigation. 2. All claims in this Action are hereby dismissed without prejudice. 3. Each party shall bear its own costs and attorneys’ fees. 4. This Court shall retain jurisdiction over Cipla and Fennec for the purpose of enforcing the terms of this Consent Judgment and Injunction and over any matters related to or arising from the interpretation or enforcement of the License Agreement or any legal or equitable claim concerning the License Agreement by any
What does dismissal without prejudice mean?
A dismissal without prejudice ends this action but leaves the claims alive — the plaintiff may file them again later, subject to the limitation period.
How long did case 2:23-cv-00123 take?
1175 calendar days, from filing on 10 Jan 2023 to closure on 30 March 2026.
Who were the attorneys and the judge in 2:23-cv-00123?
Chad Rafetto, Eliza P. O’Connor, John D. Tortorella and Kevin Harry Marino are recorded as counsel for plaintiff Fennec Pharmaceuticals. Loly G. Tor, Peter Louis Giunta and William E. Antonides III appear for defendant Cipla.
Disclaimer. This page reproduces publicly available court docket data for case 2:23-cv-00123 and is provided for general information and reference only. It is not legal advice and must not be relied upon as such.
Docket data has limits. Records are drawn from a snapshot and may lag the live docket. Sealed filings, amended complaints, counterclaims and post-closure motions may not be reflected. Party names, attorney names and firm affiliations are reproduced as recorded and may contain omissions. Where a field is absent from the record, this page marks it as not recorded rather than inferring a value.
No characterisation of the parties or the outcome. This page reports what the record contains. Nothing here should be read as an assertion that any party infringed, that any patent is valid or invalid, that any settlement occurred, or that any party prevailed.
No FTO or validity opinion. Nothing on this page constitutes a freedom-to-operate, novelty, validity or infringement opinion. Any decision touching a live patent dispute should be verified independently and reviewed with qualified patent counsel.