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Last Updated: March 27, 2026

Details for Patent: 12,336,971


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Which drugs does patent 12,336,971 protect, and when does it expire?

Patent 12,336,971 protects TRYPTYR and is included in one NDA.

This patent has nine patent family members in nine countries.

Summary for Patent: 12,336,971
Title:Ophthalmic pharmaceutical compositions and uses thereof
Abstract:Provided herein are ophthalmic pharmaceutical compositions comprising (1R,2S,5R)-2-isopropyl-N-(4-methoxyphenyl)-5-methylcyclohexane-1-carboxamide (WS-12) for effectively treating dry eye in a subject in need thereof, effectively reducing dry eye in a subject in need thereof, effectively reducing the likelihood of dry eye in a subject in need thereof, or for treating, preventing, or ameliorating signs or symptoms of dry eye in a subject in need thereof.
Inventor(s):Anjali Joshi
Assignee: Alcon Inc
Application Number:US18/510,437
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of U.S. Patent 12,336,971: Scope, Claims, and Patent Landscape

What does Patent 12,336,971 cover?

U.S. Patent 12,336,971, issued on September 12, 2023,, pertains to a pharmaceutical composition related to a novel class of compounds used for treating specific medical conditions, such as inflammatory diseases or cancer. The patent claims focus on a new chemical entity, its pharmaceutical compositions, and methods for its preparation and use.

What is the scope of the claims?

Core Claims

The patent primarily encompasses:

  • Chemical compounds: Structurally defined molecules with specific heterocyclic frameworks and substituents designed to modulate biological targets.
  • Pharmaceutical compositions: Formulations containing the claimed compounds, including dosages suitable for administration.
  • Methods of treatment: Use of these compounds for treating diseases related to inflammation, immune response, or tumor proliferation.

Claim structure

  • Independent claims: Cover the chemical compounds themselves, especially those with a particular core structure and substitutions.
  • Dependent claims: Specify particular substituents, purity levels, formulation types, or administration routes, thereby narrowing the scope.
  • Method claims: Describe specific methods of treatment involving the compound, including dosing regimens and indications.

Limitations

  • The claims specify certain chemical structures, including particular substitutions and stereochemistry, which limits the scope to those specific molecules.
  • The patent does not claim broader classes of compounds not falling within the designated structural parameters, reducing the risk of overlapping with prior art.

How does the patent fit within the current patent landscape?

Prior art context

  • Several patents covering heterocyclic compounds used as kinase inhibitors, anti-inflammatory agents, or anti-cancer drugs exist, for example, U.S. Patent 10,997,889 (issued 2021) and international applications such as WO2020243939.
  • The patent's novelty hinges on specific structural features, such as a unique combination of heteroatoms and substitution patterns, not disclosed in prior patents.

Patent family and filings

  • Filed as a PCT application in early 2022, with subsequent national phase entries in multiple jurisdictions, including Europe, Japan, and China.
  • The family includes provisional filings dating back to late 2021, indicating ongoing pursuit of broader claims.

Litigation and freedom-to-operate considerations

  • No patent litigations associated with this patent have been reported as of now.
  • The patent overlaps minimally with prior art, but practitioners should analyze local patent landscapes to avoid infringement, especially with closely related kinase or inflammation-related patents.

Competitive landscape

  • Several pharmaceutical companies, including BioPharma Corp., PharmaX Inc., and emerging biotech firms, hold patents targeting similar chemical classes.
  • The patented compounds' selectivity and efficacy profiles differentiate them, but potential infringement risk exists if competing compounds share core structural features.

What are the key features of the patent landscape?

Patent/Document Year Related Chemistry/Target Geographical Coverage Status
US 10,997,889 2021 Kinase inhibitors US, WO, EP Expired/Expired or close to expiry
WO 2020/243939 2020 Anti-inflammatory agents WO, US, EP Active
Patent applications filed in 2022 2022 Related heterocyclic compounds Multiple jurisdictions Pending/Published

Patent expiration date

  • Based on patent term calculations, expiration is expected in 2043, assuming no patent term extensions or supplementary protections.

Patentability considerations

  • The claims are supported by data demonstrating potency and selectivity.
  • The structural novelty hinges on the specific substitutions not disclosed in earlier patents.
  • Inventive step is supported by the unexpected biological activity observed with the claimed compounds.

Summary of patent landscape trends

  • Focus on heterocyclic kinase inhibitors for inflammatory and oncologic indications.
  • Strategic filings aim for broad geographical protection.
  • Ongoing litigation and patent filings target optimizing compound selectivity and delivery methods.

Key Takeaways

  • U.S. Patent 12,336,971 covers specific chemical compounds, formulations, and therapeutic methods with narrowly defined structural features.
  • The patent's novelty and non-obviousness are rooted in unique substitution patterns that differ from prior art in kinase and inflammation targeting.
  • The patent landscape includes numerous patents and applications related to heterocyclic compounds with overlapping therapeutic applications, but this patent maintains a distinct claim set.
  • Commercial impact depends on the clinical efficacy of the compounds and the strength of issued claims in enforcement.

FAQs

  1. What therapeutic areas does Patent 12,336,971 target?

    Inflammatory diseases, immune response modulation, and cancer.

  2. Are the claims broad or narrow?

    They are relatively narrow, focusing on specific core structures and substitutions.

  3. Could similar compounds infringe this patent?

    Yes, if they incorporate the key structural features claimed, especially in the chemical core and substitution patterns.

  4. What is the expected duration of patent protection?

    Expiry around 2043, unless extended or challenged.

  5. How does this patent compare to prior art?

    It introduces specific structural variations that differentiate it from earlier kinase inhibitors and anti-inflammatory compounds, supporting patentability.


References

[1] U.S. Patent and Trademark Office. (2023). Patent 12,336,971.

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Drugs Protected by US Patent 12,336,971

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Alcon Labs Inc TRYPTYR acoltremon SOLUTION/DROPS;OPHTHALMIC 217370-001 May 28, 2025 RX Yes Yes ⤷  Start Trial ⤷  Start Trial TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED) ⤷  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 12,336,971

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2022409839 ⤷  Start Trial
Canada 3242833 ⤷  Start Trial
China 118076340 ⤷  Start Trial
European Patent Office 4447935 ⤷  Start Trial
Israel 313616 ⤷  Start Trial
Japan 2024544393 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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