UroGen Pharma v. Teva: JELMYTO® Patent Dispute Dismissed With Prejudice
UroGen Pharma Ltd. and UroGen Pharma Inc. brought an infringement action in the District of Delaware against Teva Pharmaceutical Industries and Teva Pharmaceuticals USA over two patents protecting JELMYTO®, a thermoreversible poloxamer hydrogel formulation of mitomycin for low-grade upper tract urothelial cancer. The case ran 792 days before both parties' claims and counterclaims were dismissed with prejudice, with each side bearing its own costs.
JELMYTO® Hydrogel Patent Dispute: 792 Days to Bilateral Dismissal
UroGen Pharma Ltd. and UroGen Pharma Inc. filed suit on 2 April 2024 in the U.S. District Court for the District of Delaware before Judge John F. Murphy, asserting infringement of US9040074B2 and US9950069B2. Both patents relate to JELMYTO® (mitomycin) for pyelocalyceal solution — specifically a sterile thermoreversible hydrogel composition comprising poloxamer (23–27% w/w), HPMC (0.1–0.2%), and PEG-400 (0.5–1%) indicated for adult patients with low-grade Upper Tract Urothelial Cancer. Teva Pharmaceutical Industries Ltd. and Teva Pharmaceuticals USA, Inc. were named as defendants, consistent with an ANDA-type challenge pattern in the speciality pharmaceutical space.
The case closed on 3 June 2026 when the court issued a dismissal order, at the joint request of both parties, dismissing all of plaintiffs' claims and all of defendants' counterclaims with prejudice. Neither side was awarded costs. The court expressly retained jurisdiction to enforce the order and the terms of a parties' settlement agreement, the specific terms of which are not disclosed in the available public record.
At 792 days, the case resolved before reaching trial — a timeline that suggests the parties moved through early discovery and claim construction phases before arriving at resolution. The bilateral dismissal with prejudice and mutual cost-bearing, combined with the court's retention of jurisdiction over a settlement agreement, suggests the parties reached a negotiated resolution, though the specific terms are not disclosed in the available record. What remains unknown is whether any licensing, market entry timing, or product restrictions form part of the underlying settlement.
See Complete Case & Patent Analysis →Filing to Dismissed with Prejudice in 792 days
792 days from filing to dismissal — consistent with Hatch-Waxman ANDA timelines reaching settlement before trial
US9040074B2 & US9950069B2 — JELMYTO® thermoreversible hydrogel for LG-UTUC
Any pharmaceutical developer, CDMO, or generic applicant working on thermoreversible hydrogel drug delivery systems — particularly poloxamer-based formulations for intracavitary or urological applications — should treat these two patents as live risk. Both remain in force following this litigation. Companies exploring mitomycin reformulations, biosimilar instillation products, or poloxamer hydrogel platforms for oncology indications in the upper urinary tract should conduct FTO analysis before initiating IND or ANDA filings.
Official order — verbatim text
The dismissal order, entered at the joint request of both parties, extinguishes all claims and counterclaims with prejudice and records that each party bears its own costs. The court's express retention of jurisdiction over 'the terms of the parties' settlement agreement' confirms that an underlying agreement governs the post-litigation relationship between UroGen and Teva, though the specific terms are not disclosed in the available public record.
Dismissed with prejudice: what the bilateral dismissal means for both parties
Dismissal with prejudice bars re-litigation of these claims
A dismissal with prejudice is a final adjudication on the merits as a matter of procedure — neither UroGen nor Teva may re-file the same patent infringement claims or counterclaims that were the subject of this action. The court retained jurisdiction to enforce the order and the parties' settlement agreement, indicating that the dismissal is tied to a binding underlying arrangement, the specific terms of which are not disclosed in the available record.
Claims extinguished — no re-filingUroGen's patents survive but infringement claims are closed
US9040074B2 and US9950069B2 remain in force — they were not invalidated by the court. However, UroGen's infringement claims against Teva are permanently extinguished. Whether UroGen obtained any commercial protection through the settlement agreement — such as market exclusivity timing — is not disclosed in the available public record.
Patents intact; claims extinguishedTeva's counterclaims dismissed — invalidity arguments not adjudicated
Teva's counterclaims against UroGen — which in ANDA litigation typically include invalidity and non-infringement arguments — were also dismissed with prejudice. This means Teva cannot re-assert those specific counterclaims in a new action. The practical implications for Teva's ability to market any competing product depend on the undisclosed terms of the settlement agreement.
Counterclaims extinguishedUndisclosed settlement terms leave market entry timing uncertain
For competitors and formulary decision-makers, the bilateral dismissal with a confidential settlement is a common endpoint in Hatch-Waxman ANDA litigation. The court's retention of jurisdiction to enforce the settlement agreement signals an ongoing compliance structure between the parties. R&D teams working on poloxamer-based thermoreversible hydrogel drug delivery systems should note that US9040074B2 and US9950069B2 remain active IP barriers — neither was held invalid in these proceedings.
Settlement terms undisclosedFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | UroGen Pharma Ltd. | Company | /Search in Eureka ↗ |
| Co-Plaintiff | UroGen Pharma Inc. | Company | Search in Eureka ↗ |
| Defendant | Teva Pharmaceutical Industries, Ltd. | Company | /Search in Eureka ↗ |
| Co-Defendant | Teva Pharmaceutical Industries, Ltd. | Company | Search in Eureka ↗ |
| Co-Defendant | Teva Pharmaceuticals USA, Inc. | Company | Search in Eureka ↗ |
| Plaintiff counsel | Alexandra M. Joyce | Attorney | Counsel for UroGen Pharma Ltd.Search in Eureka ↗ |
| Plaintiff counsel | Amy R. Harriman | Attorney | Counsel for UroGen Pharma Ltd.Search in Eureka ↗ |
| Plaintiff counsel | Daniel J. Minion | Attorney | Counsel for UroGen Pharma Ltd.Search in Eureka ↗ |
| Plaintiff counsel | Daniel M. Silver | Attorney | Counsel for UroGen Pharma Ltd.Search in Eureka ↗ |
| Plaintiff counsel | Evan S. Krygowski | Attorney | Counsel for UroGen Pharma Ltd.Search in Eureka ↗ |
| Plaintiff counsel | James R. Tyminski | Attorney | Counsel for UroGen Pharma Ltd.Search in Eureka ↗ |
| Plaintiff counsel | Jusin M. Dersh | Attorney | Counsel for UroGen Pharma Ltd.Search in Eureka ↗ |
| Plaintiff counsel | Philip J. Dutko | Attorney | Counsel for UroGen Pharma Ltd.Search in Eureka ↗ |
| Plaintiff counsel | William E. Solander | Attorney | Counsel for UroGen Pharma Ltd.Search in Eureka ↗ |
| Plaintiff law firm | McCarter & English LLP | Law Firm | Representing UroGen Pharma Ltd.Search in Eureka ↗ |
| Defendant counsel | Brady P. Gleason | Attorney | Counsel for Teva Pharmaceutical Industries, Ltd.Search in Eureka ↗ |
| Defendant counsel | Christina E. Dashe | Attorney | Counsel for Teva Pharmaceutical Industries, Ltd.Search in Eureka ↗ |
| Defendant counsel | John Christopher Rozendaal | Attorney | Counsel for Teva Pharmaceutical Industries, Ltd.Search in Eureka ↗ |
| Defendant counsel | Karen Elizabeth Keller | Attorney | Counsel for Teva Pharmaceutical Industries, Ltd.Search in Eureka ↗ |
| Defendant counsel | Nathan Roger Hoeschen | Attorney | Counsel for Teva Pharmaceutical Industries, Ltd.Search in Eureka ↗ |
| Defendant counsel | Paul A. Ainsworth | Attorney | Counsel for Teva Pharmaceutical Industries, Ltd.Search in Eureka ↗ |
| Defendant counsel | Zachary L. Jacobs | Attorney | Counsel for Teva Pharmaceutical Industries, Ltd.Search in Eureka ↗ |
| Defendant law firm | Shaw Keller LLP | Law Firm | Representing Teva Pharmaceutical Industries, Ltd.Search in Eureka ↗ |
| Presiding judge | Judge John F. Murphy | Judge | Delaware District CourtSearch in Eureka ↗ |
R&D signals in the thermoreversible hydrogel drug delivery space
Patent and filing intelligence around UroGen's JELMYTO® platform, poloxamer hydrogel formulation trends, and Teva's position in specialty urology — derived from this case.
UroGen's formulation IP: how deep is the JELMYTO® moat?
US9040074B2 and US9950069B2 share a continuation lineage through application numbers US13/553198 and US15/366256. Mapping UroGen's full portfolio around these applications — including continuations, divisionals, and international equivalents — can reveal whether the poloxamer composition window claims are a narrow spike or part of a broader formulation estate protecting JELMYTO® across multiple jurisdictions.
UroGen portfolio depthThermoreversible hydrogel filing trends in intracavitary oncology delivery
Poloxamer-based thermoreversible hydrogels are an active area of pharmaceutical innovation, with applications spanning urology, ophthalmology, and intratumoral delivery. Tracking recent patent filings in this composition space — particularly those claiming poloxamer 407 concentrations, HPMC co-formulations, and controlled-release modifications — can identify emerging competitive platforms that may approach or design around UroGen's claimed composition windows.
Hydrogel filing trendsTeva's specialty urology and hydrogel formulation IP position
Teva is one of the world's largest generic manufacturers and holds an extensive specialty pharmaceutical portfolio. Assessing Teva's own patent filings in thermoreversible or sustained-release urology formulations — alongside its ANDA pipeline disclosures — can signal whether Teva is pursuing proprietary formulation differentiation in this space or positioning primarily as a generic entrant against JELMYTO®.
Teva urology IPDesign-around opportunities near UroGen's poloxamer composition claims
UroGen's claims define narrow composition ranges: 23–27% poloxamer, 0.1–0.2% HPMC, 0.5–1% PEG-400. R&D teams exploring alternative thermoreversible hydrogel carriers — including different poloxamer grades, alternative viscosity modifiers, or co-polymer blends — may find white space outside these precise windows. Mapping adjacent claim space and freedom-to-operate around these ranges is a key priority for any competing LG-UTUC formulation program.
Formulation design-aroundSimilar ANDA patent cases: thermoreversible hydrogel & urology drug formulations
Explore comparable Hatch-Waxman infringement actions in the District of Delaware involving specialty pharmaceutical formulation patents and oncology drug delivery systems.
What this case signals for the specialty urology IP landscape
Two active formulation patents, a confidential settlement, and a court retaining enforcement jurisdiction — this case carries clear signals for generic entrants and innovators alike.
JELMYTO® formulation patents remain valid enforcement tools post-dismissal
Neither US9040074B2 nor US9950069B2 was invalidated. Any party seeking to develop a competing thermoreversible hydrogel mitomycin product for upper tract urothelial cancer should conduct a thorough FTO analysis against both patents before advancing to clinical or regulatory filing stages.
Court's retained jurisdiction signals ongoing settlement compliance obligations
The dismissal order expressly preserves the court's jurisdiction to enforce the settlement agreement. This is a material procedural signal: the parties have ongoing obligations, and any breach could be adjudicated by Judge Murphy in the District of Delaware without a new filing — a meaningful enforcement lever for UroGen.
UroGen v Teva — key questions answered
UroGen Pharma Ltd. and UroGen Pharma Inc. asserted two patents: US9040074B2 (application no. US13/553198) and US9950069B2 (application no. US15/366256). Both patents cover JELMYTO® — a sterile thermoreversible poloxamer hydrogel formulation of mitomycin for treatment of adult patients with low-grade Upper Tract Urothelial Cancer (LG-UTUC).
The case was dismissed with prejudice by court order on 3 June 2026, at the joint request of both parties. All of UroGen's infringement claims and all of Teva's counterclaims were extinguished. Dismissed with prejudice means neither party may re-file the same claims in a new action. The court retained jurisdiction to enforce the order and the parties' settlement agreement; the specific terms of that agreement are not disclosed in the available public record.
JELMYTO® (mitomycin) for pyelocalyceal solution is a first-in-class thermoreversible hydrogel product for ablative treatment of low-grade Upper Tract Urothelial Cancer. The product's key composition — poloxamer 23–27% w/w, HPMC 0.1–0.2%, PEG-400 0.5–1% — is protected by US9040074B2 and US9950069B2. Neither patent was invalidated in this litigation, meaning both remain active barriers for any generic or competing thermoreversible hydrogel mitomycin product.
No. The case was resolved by bilateral dismissal with prejudice before any judicial ruling on validity or infringement. The court's dismissal order does not adjudicate the merits of either party's claims or Teva's counterclaims. US9040074B2 and US9950069B2 remain in force and were not held invalid by the Delaware District Court in these proceedings.
The dismissal order states that the court retains jurisdiction to enforce the order and the terms of the parties' settlement agreement. This means that if either party alleges a breach of the settlement, they may seek enforcement directly before Judge John F. Murphy in the District of Delaware without needing to file a new lawsuit. The specific terms of the settlement agreement are not disclosed in the available public record.
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