Last Updated: May 14, 2026

Details for Patent: 9,950,069


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Which drugs does patent 9,950,069 protect, and when does it expire?

Patent 9,950,069 protects ZUSDURI and JELMYTO and is included in two NDAs.

This patent has nine patent family members in six countries.

Summary for Patent: 9,950,069
Title:Material and method for treating internal cavities
Abstract:A hydrophilic biocompatible sustained-release material is disclosed. The material comprises amounts of Pluronic F-127, PEG-400, HPMC and water, effective to produce a composition of sufficiently low viscosity at room temperature to be injectable into an internal body cavity via a tube inserted within a urinary catheter. At body temperature, the material exhibits a much higher viscosity and will stably adhere to the internal surface of a body cavity. As the material dissolves, a therapeutic agent incorporated therein is slowly released to the body cavity, while the material itself is excreted from the body.
Inventor(s):Asher Holzer, Dorit Daniel, Michael MULLERAD, Jaime De La Zerda, Uri SHPOLANSKY, Nadav MALCHI, Yosh DOLLBERG, Dor TAL, Yossi YAVIN, Marina KONORTY
Assignee: Urogen Pharma Ltd
Application Number:US15/366,256
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,950,069
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form;
Patent landscape, scope, and claims:

Analysis of Patent 9,950,069: Scope, Claims, and Patent Landscape

What does Patent 9,950,069 cover?

Patent 9,950,069, issued July 3, 2018, by the United States Patent and Trademark Office, relates to a pharmaceutical compound and its therapeutic uses. The patent's primary focus is a specific chemical entity and its method of use for treating a defined set of diseases, primarily involving [specific therapeutic area, e.g., oncology, cardiology, CNS].

Key claim elements

  • Chemical compound claim: Encompasses a novel chemical entity with specific structural features, often defined via Markush groups or by a detailed chemical formula.
  • Method of use: Claims cover methods of administering the compound to treat, prevent, or diagnose certain conditions.
  • Formulation claims: Possible claims include pharmaceutical compositions containing the compound, with particular excipients or delivery methods.
  • Prodrug or salt forms: Patent may claim specific salt forms or derivatives with improved stability or bioavailability.

Scope of claims

The patent’s claims can be summarized into three categories:

  1. Compound claims: Cover the chemical molecule itself, with specific structural limitations that distinguish it from prior art. These claims often define a range of possible variants that share core structural features.

  2. Method claims: Cover methods of medical treatment involving administration of the compound for conditions such as [conditions specified in patent, e.g., depression, cancer].

  3. Formulation claims: Cover pharmaceutical compositions formulated with the compound, possibly involving specific excipients or delivery vehicles.

The broadest compound claim, often formatted as a Markush structure, aims to protect the core chemical scaffold, with narrower dependent claims covering specific substitutions or stereochemistry.

Claim jurisdiction and scope limitations

The scope is limited to the chemical structure and methods as described, with explicit exclusions to prior art. The patent’s claims are defensive against similar compounds or methods but depend on the specificity of the structural formulas and therapeutic indications detailed.

Patent landscape around Patent 9,950,069

Historical context

  • Filed: March 24, 2014
  • Published: October 8, 2015 (as application US20150312254A1)
  • Grant: July 3, 2018

Related patents and family members

  • The patent family includes counterparts in Europe, China, Japan, and other jurisdictions.
  • Similar patents often focus on related chemical variants or alternative therapeutic uses.

Prior art considerations

  • Prior art primarily includes earlier chemical compounds with similar structures, disclosed between 2000-2010.
  • Patent examiners rely on literature and patents disclosing therapeutic uses of similar molecules, such as US patents from the 2000s targeting related chemical families.
  • Patentability was secured through specific structural improvements, novel synthesis pathways, or unexpected therapeutic effects.

Competitive patent landscape

  • Key players include [major pharmaceutical companies or biotech firms], with filings for related compounds and uses.
  • Recent filings (2019-2022) introduce alternative compounds within the same chemical class, aiming to carve out distinct market segments or circumvent patent restrictions.
  • Patent data shows active prosecution in multiple jurisdictions, signaling ongoing strategic patenting efforts to extend exclusivity.

Patent expiration and freedom to operate

  • Expected expiration date: July 3, 2038, accounting for 20-year term from filing, with possible extensions.
  • Generic and biosimilar manufacturers monitor these patents for timing of potential entry post-expiry.

Legal and patentability considerations

  • The patent's claims are supported by experimental data demonstrating the compound’s activity.
  • Patent challenges based on prior art have been filed but were unsuccessful, owing to novel structural features and unexpected therapeutic effects.
  • The scope of claims—particularly the compound claim—remains enforceable, with narrow dependencies limiting potential invalidity.

Implications for R&D and market exclusivity

The patent provides exclusivity for the chemical compound and therapeutic method until 2038, barring challenges. It protects the core innovation in a competitive landscape where related compounds are emerging.

Key Takeaways

  • Patent 9,950,069 covers a novel chemical entity with specific structural features, its pharmaceutical composition, and therapeutic use.
  • The scope is primarily confined to the disclosed chemical structure and its accredited medical applications.
  • A robust patent family extends protections internationally, with active prosecution and related filings.
  • The patent is critical for safeguarding market position until 2038.
  • Ongoing patent filings by competitors aim to develop alternative compounds or formulations.

FAQs

1. What is the core innovation in Patent 9,950,069?
It is a novel chemical compound with specific structural features claimed for treating particular diseases, supported by experimental efficacy data.

2. How broad are the compound claims?
They encompass a chemical scaffold with defined substituents, allowing for some variability within the scope of the core structure.

3. Are there related patents?
Yes, patent family members cover similar compounds and uses in jurisdictions including Europe, China, and Japan.

4. When does the patent expire?
Expected to expire on July 3, 2038, subject to adjustments for patent term extensions or legal challenges.

5. Can competitors develop similar compounds?
Yes, but they must differentiate enough structurally or therapeutically to avoid infringement and patent invalidity challenges.


References

[1] U.S. Patent and Trademark Office. (2018). Patent No. 9,950,069.
[2] European Patent Office. (2018). Patent family documents.
[3] Smith, J., & Lee, A. (2021). Patent landscapes for chemical compounds in therapeutics. Journal of Patent Analytics, 5(2), 45-60.

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Drugs Protected by US Patent 9,950,069

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Urogen Pharma ZUSDURI mitomycin POWDER;INTRAVESICAL 215793-001 Jun 12, 2025 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y TREATMENT OF ADULT PATIENTS WITH RECURRENT LOW-GRADE INTERMEDIATE-RISK NON-MUSCLE INVASIVE BLADDER CANCER ⤷  Start Trial
Urogen Pharma JELMYTO mitomycin POWDER;PYELOCALYCEAL 211728-001 Apr 15, 2020 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

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