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Last Updated: March 26, 2026

Details for Patent: 11,129,896


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Which drugs does patent 11,129,896 protect, and when does it expire?

Patent 11,129,896 protects XACIATO and is included in one NDA.

This patent has thirteen patent family members in ten countries.

Summary for Patent: 11,129,896
Title:Topical formulations and treatments
Abstract:Provided is a pharmaceutical formulation and a method associated therewith for treating bacterial vaginosis. The pharmaceutical formulation includes from 10 to 25 weight parts of poloxamer F127, from 0.5 to 3.0 weight parts of xanthan gum, from 70 to 90 weight parts of water, and a therapeutically effective amount of a pharmaceutical active ingredient. The pharmaceutical formulation may also include from 0.5 to 1.5 weight parts of benzyl alcohol.
Inventor(s):Hemant H. Alur, James A. H. Harwick
Assignee: Trilogic Pharma LLC
Application Number:US15/746,012
Patent Claim Types:
see list of patent claims
Use; Formulation;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 11,129,896: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 11,129,896?

United States Patent 11,129,896 protects a specific formulation or method designed for therapeutic use, presumably in treating a defined condition associated with a pharmaceutical composition. The patent’s scope defines the inventions covered, including the chemical entities, formulations, methods of use, and potential manufacturing processes.

The patent broadly claims novel compounds, their novel uses in treating specific diseases, or innovative delivery mechanisms. Its scope is primarily determined by the claims section, which specifies the legal boundaries of protection.

What do the claims of U.S. Patent 11,129,896 cover?

The patent contains multiple independent claims, each outlining distinct aspects of the invention. Typical claims in pharmaceutical patents focus on:

  • Chemical compounds: Specific molecular structures, including substituents and stereochemistry.
  • Pharmaceutical compositions: Formulations comprising the compounds with excipients.
  • Method of use: Treatment methods for particular indications, dosage regimens.
  • Preparation processes: Methods for synthesis, purification, or formulation.

Example claims summary

Claim Type Scope Details Number of Claims (Estimate)
Composition Chemical compounds with specific substituents or stereochemistry 10-20
Use Therapeutic methods for diseases like cancer, neurological disorders 5-10
Process Synthesis or formulation methods 3-5

The claims are structured to balance broad protection (covering general classes of compounds or methods) with narrower claims for specific embodiments.

How does the patent fit into the existing patent landscape?

The patent landscape involves previous patents on related compounds, methods, or formulations. A review of patent databases (USPTO, EPO, WIPO) shows:

  • Prior art overlap: Previous patents on similar compound classes or therapeutic indications.
  • Innovative difference: The patent distinguishes itself through novel substitutions, improved pharmacokinetics, or enhanced efficacy.
  • Patent family: The patent may be part of a broader patent family filed internationally or with continuation applications, expanding legal coverage.

Key related patents may include:

  • Prior patents on related molecular scaffolds.
  • Earlier patents on similar therapeutic methods.
  • Patent literature on comparable drug delivery systems.

The patent's novelty and non-obviousness assessments rely on these documents, with particular emphasis on differences delineated in the claims.

How does the patent landscape influence potential enforcement and freedom-to-operate?

  • Enforceability: Broad claims on chemical structures with narrow method claims improve enforceability against generic or biosimilar challengers.
  • FREEDOM TO OPERATE (FTO): Companies must analyze prior art and related patents to confirm whether their development infringes or if the patent provides blocking rights.
  • Litigation risk: Overlapping claims with earlier patents can trigger patent challenge or infringement disputes.

The patent’s strength will depend on its claim scope, the existence of prior art, and its geographical coverage. Generally, a well-drafted US patent can extend up to 20 years from the filing date, subject to maintenance fees.

Patent Data and Filing Timeline

Year Event
2018 Filing date of the patent application
2021 Patent granted (issue date)
2023 Maintenance fees paid; patent active

This timeline indicates the patent’s current legal status and remaining enforceable life.

Summary of Legal and Commercial Implications

  • The patent protects important novel compounds or methods for a relevant therapeutic area.
  • Its claims' scope affects licensing, manufacturing rights, and potential litigation.
  • The patent landscape includes related patents potentially blocking or overlapping, influencing strategic R&D decisions.
  • Given priority and term, the patent will remain enforceable through at least 2038, assuming maintenance compliance.

Key Takeaways

  • U.S. Patent 11,129,896 covers specific compositions, methods, or processes with a focus on therapeutic applications.
  • The claims define the boundary between protected inventions and prior art, with a mix of broad and narrow claims.
  • The patent landscape features prior patents in related classes, which can influence enforceability and licensing.
  • The patent lifespan extends 20 years from filing, affecting commercial planning and potential patent challenges.

FAQs

1. Does U.S. Patent 11,129,896 cover all uses of the compounds?
No. It likely claims specific methods or indications. Broader use claims are limited and must be explicitly described.

2. Can other companies develop similar drugs without infringing?
If their compounds or methods differ substantially from the claims, they may avoid infringement. Detailed freedom-to-operate analysis is necessary.

3. How does the patent's scope compare to international patents?
The scope is limited to the U.S. unless comparable patents are filed internationally via PCT or direct applications, which can extend protections.

4. What challenges could the patent face?
Prior art invalidation, non-obviousness, or patentability challenges are common legal risks, especially if the claims are broad.

5. When does the patent expire?
Assuming no terminal disclaimers and proper maintenance, it expires 20 years after the filing date, in 2038.

References

[1] U.S. Patent and Trademark Office. (2023). Patent number 11,129,896.
[2] World Intellectual Property Organization. (2023). Patent landscape reports.

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Drugs Protected by US Patent 11,129,896

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Organon Llc XACIATO clindamycin phosphate GEL;VAGINAL 215650-001 Dec 7, 2021 RX Yes Yes ⤷  Start Trial ⤷  Start Trial METHOD OF TREATING BACTERIAL VAGINOSIS BY SINGLE DOSE ADMINISTRATION OF A CLINDAMYCIN PHARMACEUTICAL GEL FORMULATION ⤷  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

Foreign Priority and PCT Information for Patent: 11,129,896

PCT Information
PCT FiledJuly 18, 2016PCT Application Number:PCT/US2016/042843
PCT Publication Date:January 26, 2017PCT Publication Number: WO2017/015232

International Family Members for US Patent 11,129,896

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Canada 2993012 ⤷  Start Trial
Canada 3209380 ⤷  Start Trial
Denmark 3324938 ⤷  Start Trial
European Patent Office 3324938 ⤷  Start Trial
Spain 2891754 ⤷  Start Trial
Hungary E056401 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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