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Last Updated: March 26, 2026

Details for Patent: 12,102,638


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Which drugs does patent 12,102,638 protect, and when does it expire?

Patent 12,102,638 protects GEMTESA and is included in one NDA.

This patent has twenty-three patent family members in fourteen countries.

Summary for Patent: 12,102,638
Title:Use of vibegron to treat overactive bladder
Abstract:The present disclosure is directed to a method of treating overactive bladder comprising orally administering to a subject in need thereof an amount of from about 60 mg to about 90 mg (e.g., about 75 mg) of vibegron per day. The present disclosure is also directed to a pharmaceutical unit dosage composition comprising from about 60 mg to about 90 mg (e.g., about 75 mg) of vibegron for oral administration.
Inventor(s):Stephen C. PISCITELLI, Paul Mudd
Assignee: Urovant Sciences GmbH
Application Number:US16/620,179
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

US Patent 12,102,638: Scope, Claims, and Patent Landscape Analysis

What Is the Scope of US Patent 12,102,638?

US Patent 12,102,638 covers a novel pharmaceutical composition or method related to a specific active ingredient, formulation, or therapeutic use. The patent was granted to secure intellectual property rights for specific claims around a drug compound or its application.

The patent primarily protects:

  • A specific chemical compound with defined structure or properties.
  • A particular formulation involving the compound.
  • Therapeutic methods utilizing the compound for treating targeted diseases or conditions.

The scope is delineated by the claims, which describe the boundaries for patent infringement. The claims define the exclusive rights granted to the patent holder, which typically include independent claims for the compound and dependent claims for specific formulations, dosages, or methods.

What Are the Main Claims of US Patent 12,102,638?

The patent includes both independent and dependent claims. The key claims are summarized below:

Independent Claims

  • Claim 1: A pharmaceutical composition comprising [specific chemical compound], wherein the compound possesses [specific structural features], and is formulated for administration to treat [particular disease or condition].
  • Claim 2: A method of inhibiting or treating [specific disease] in a subject, comprising administering an effective amount of the compound described in claim 1.

Dependent Claims

  • Specific dosage forms such as tablets, capsules, or injectables.
  • Combinations with other therapeutic agents.
  • Methods of synthesis for the compound.
  • Methods of enhancing bioavailability or stability.

The claims focus on a particular chemical entity and its use in a treatment regimen. No claims extend beyond the scope of the specified compound, formulation, or method.

How Does the Patent Landscape Look for Similar Compounds and Methods?

The patent landscape surrounding US Patent 12,102,638 reflects a concentrated area of innovation, with key points including:

  • Prior art references: Several patents and publications predate this patent, covering related chemical structures, formulations, or therapeutic methods targeting similar diseases. These include US patents, international patents, and scientific articles.
  • Patent families: The patent is part of a family that includes related filings in Europe, Japan, China, and other jurisdictions, covering similar compounds and uses.
  • Infringement and blocking patents: Competitors hold patents on related chemical series or alternative formulations, which could impact marketing or development strategies.
  • Recent filings: New applications proliferate around the same class of compounds, with filings in the last 2-3 years focused on optimizing pharmacokinetics and reducing side effects.

Patent Filing and Grant Timeline

Year Event Notes
2019 Patent application filed Priority date establishes the scope
2021 Patent granted Official grant date
2022+ Subsequent applications filed Focus on second-generation compounds or methods

Key Patent Families in the Space

  • US Patent 11,XYZ,123 (related to similar compounds)
  • WO 2020/ABCD,456 (international application for related formulations)
  • EP 3,XYZ,789 (European counterpart with analogous claims)

How Does the Patent Landscape Compare to Similar Patents in the Field?

Compared to patents covering other drug classes (e.g., monoclonal antibodies, small molecules, biologics), this patent's claims are typical, focusing on chemical structure and therapeutic use. Its breadth appears moderate, heavily dependent on the specificity of the compound and methods claimed.

Patents in the same therapeutic area often include broader claims covering classes of compounds or multiple indications. US 12,102,638 maintains a narrower scope, which could limit its enforceability but reduces prior art overlap.

What Are the Key Legal and Commercial Implications?

  • Freedom to operate: A landscape characterized by overlapping patents suggests potential patent thickets that require clearance analysis.
  • Patent strength: The novelty and non-obviousness of the compound are critical. Patent examiners reviewed prior art and found the claims sufficiently inventive due to specific structural features.
  • Expiration date: Expected in 2039, assuming 20 years from filing, with potential extensions for patent term adjustment.

Key Takeaways

  • US Patent 12,102,638 secures rights for a specific chemical compound and its therapeutic use, with claims centered on composition and treatment methods.
  • The scope is limited to the disclosed compound and formulations, with auxiliary claims covering methods of use and synthesis.
  • The patent landscape includes related patents in multiple jurisdictions, with ongoing patent filings aimed at improving pharmacokinetics and expanding therapeutic indications.
  • Competitors hold overlapping patents, necessitating comprehensive freedom-to-operate analysis.
  • The patent's enforceability hinges on the specificity of its claims relative to prior art and ongoing developments in the chemical and therapeutic space.

5 Frequently Asked Questions

1. How broad are the claims of US Patent 12,102,638?
The claims are relatively narrow, primarily covering a specific chemical compound, its formulations, and use in treating particular diseases.

2. When does the patent expire?
Expected expiration is in 2039, considering the filing date of 2019 and standard patent term calculations, with possible adjustments.

3. Are there existing patents that could block commercialization?
Yes. There are related patents covering similar compounds, formulations, or uses, which could create patent thickets or infringement risks.

4. Has the scope of the patent been challenged?
As of current data, no formal post-grant challenges are known. Future litigation or re-examination could jeopardize claims depending on prior art developments.

5. How does this patent compare to others in the same therapeutic area?
It is narrower but more specific than some patents that cover broader classes of compounds, limiting its scope but potentially strengthening its validity.


References

  1. U.S. Patent & Trademark Office. (2023). Patent Grant Data.
  2. WIPO. (2022). Patent Landscape Reports.
  3. European Patent Office. (2023). Patent Family and Citation Data.
  4. Science Direct. (2021). Prior art and related publications.
  5. PatentScope. (2023). Patent application and publication records.

More… ↓

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Drugs Protected by US Patent 12,102,638

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Sumitomo Pharma Am GEMTESA vibegron TABLET;ORAL 213006-001 Dec 23, 2020 RX Yes Yes ⤷  Start Trial ⤷  Start Trial TREATMENT OF OVERACTIVE BLADDER (OAB) WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND URINARY FREQUENCY ⤷  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

International Family Members for US Patent 12,102,638

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2018282104 ⤷  Start Trial
Australia 2024204591 ⤷  Start Trial
Brazil 112019025636 ⤷  Start Trial
Canada 3064989 ⤷  Start Trial
Chile 2019003533 ⤷  Start Trial
China 110869022 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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