BioTech IP Review

Material and Method for Treating Cancer

Assignee: UroGen Pharma Ltd.
Patent Number: US 12,336,979 B2
Filed: December 9, 2021 (priority from earlier filings)
Issued: June 24, 2025
Title: Material and Method for Treating Cancer
Category: Pharmaceutical compositions & sustained‑release local therapy

What This Patent Covers

This patent protects sustained‑release pharmaceutical compositions and methods for local treatment of cancer, focusing on **embedding lyophilized mitomycin C — a chemotherapy agent — in a biocompatible, slowly releasing hydrogel.

Key aspects include:

  • Hydrogel‑based delivery system: A thermoreversible biocompatible hydrogel that transitions from liquid to gel at body temperature, enabling sustained local release of the therapeutic agent at the tumor site.
  • Lyophilized mitomycin C: A freeze‑dried form of mitomycin C is incorporated into the hydrogel to optimize stability and controlled release.
  • Local administration: Designed for intravesical application (e.g., into the bladder), where prolonged exposure to the chemotherapy agent increases efficacy against tumors (such as non‑muscle‑invasive bladder cancer) while minimizing systemic toxicity.

The technology reflects UroGen’s RTGel® sustained‑release platform, which underlies key products including ZUSDURI™ (mitomycin for intravesical use) — approved by the U.S. FDA in June 2025 for certain bladder cancers — reinforcing how this IP supports commercial value.

Why This Patent Is Important

Core to FDA‑approved product: The sustained‑release hydrogel approach protected by this patent is central to ZUSDURI’s mechanism of action — a non‑surgical bladder cancer therapy that keeps chemotherapy in the bladder longer to improve outcomes.

Long protection term: This patent, issued in 2025, will remain in force into the 2030s and likely longer with extensions (typical 20‑year term from filing), securing exclusivity for this delivery technology on multiple indications.

Covers next‑gen programs: It extends to next‑generation mitomycin products such as UGN‑103 and UGN‑104, which combine UroGen’s RTGel® technology with new formulations designed for improved manufacturing and patient convenience — expected to enter Phase 3 in 2025 and protected through December 2041 once related applications issue as patents.

IP moat & enforcement: UroGen actively enforces earlier patents (e.g., against generic filings for JELMYTO®) and this newer patent expands the company’s portfolio protecting local sustained‑release cancer therapies, strengthening its competitive position.

Summary

US 12,336,979 B2 (Material and Method for Treating Cancer) is among UroGen’s most commercially important patents because it protects the sustained‑release hydrogel platform that enables locally administered oncology therapies — directly supporting FDA‑approved ZUSDURI™ and future products like UGN‑103/UGN‑104. This technology enhances treatment efficacy and patient convenience while securing long‑term exclusivity for UroGen’s pipeline.

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