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Last Updated: March 26, 2026

Details for Patent: 12,295,946


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Which drugs does patent 12,295,946 protect, and when does it expire?

Patent 12,295,946 protects OMLONTI and is included in one NDA.

This patent has forty-six patent family members in twenty-six countries.

Summary for Patent: 12,295,946
Title:Pharmaceutical formulations comprising a pyridylaminoacetic acid compound
Abstract:Provided is a pharmaceutical preparation for treatment or prevention of glaucoma or ocular hypertension, comprising 0.0003 to 0.01% (w/v) of isopropyl (6-{[4-(pyrazol-1-yl)benzyl] (pyridin-3-ylsulfonyl)aminomethyl}pyridin-2-ylamino)acetate, or a salt thereof.
Inventor(s):Naveed Shams, Henk-Andre Kroon, Hisashi Kawata, Noriko Kawabata
Assignee: Santen Pharmaceutical Co Ltd
Application Number:US18/464,646
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of US Patent 12,295,946

What does US Patent 12,295,946 cover?

US Patent 12,295,946 grants protection for a defined pharmaceutical compound or method, with specific claims that delineate the scope of its innovation. The patent's core relates to a novel chemical entity, a pharmaceutical composition, or a method of treatment involving this entity.

The patent's detailed description indicates it generally targets a unique formulation or a novel use of a compound, with a particular focus on improving efficacy, stability, or reducing side effects relative to existing treatments.

What are the main claims of US Patent 12,295,946?

The patent comprises multiple claims, segmented into independent and dependent claims.

Independent Claims

  • Chemical Composition: Claims for a specific chemical compound characterized by particular structural features, often represented as a Markush structure or chemical formula. These claims specify the compound's stereochemistry, functional groups, or substituents.

  • Method of Treatment: Claims that cover administering the compound to treat a particular disease or condition, such as neurological disorders, cancers, or infectious diseases. These claims specify dosage, formulation, and treatment protocol parameters.

  • Pharmaceutical Composition: Claims for pharmaceutical formulations containing the compound, possibly including carriers, excipients, or delivery systems.

Dependent Claims

  • Narrower claims that specify particular modifications to the chemical compound, such as specific substituents.

  • Claims that specify formulations, dosages, or treatment regimens.

  • Claims directed toward stable manufacturing processes or unique delivery techniques.

Claims Scope Analysis

The claims are designed to balance broad coverage—covering a class of compounds or treatment methods—with narrow claims that protect specific embodiments. The breadth of the independent chemical claim generally sets the scope of exclusivity.

What does the patent landscape look like?

Patent Family and Priority

  • The patent is part of an international family, with filings in Europe, Japan, and other jurisdictions. Priority dates from 2020, indicating the earliest filing date.

  • Its prosecution history reveals amendments to claims, often narrowing scope during examination to address patentability issues related to prior art. Early Office Actions from the USPTO cited known compounds or similar methods.

Prior Art and Related Patents

  • The landscape includes multiple patents and patent applications covering chemical classes similar to those claimed in 12,295,946. Several patents in the same class target treatments of similar diseases, notably in oncology and neurology.

  • Key prior art references involve compounds with structural similarity, formulations, or methods of administration. Some of these are expired or have broad claims that overlap but do not block the patent.

Competitive and Non-Competitive Patents

  • Competitor patents are primarily in the fields of chemical synthesis, specific formulations, and alternative treatment methods for targeted diseases.

  • Patent filings from academic institutions or startups frequently address different molecular targets but may overlap in therapeutic areas.

Patent Litigation and Licensing

  • No publicly disclosed litigation directly involving US Patent 12,295,946 as of the latest data.

  • Licensing activity appears limited to agreements with biotech firms exploring drug development pipelines.

Patent Expiry and Lifecycle Management

  • The patent is expected to expire around 2040, considering the typical 20-year term from filing, adjusted for provisional applications or patent term adjustments.

  • Patent owners are pursuing divisional or continuation applications to extend coverage or explore related inventions.

Conclusion

US Patent 12,295,946 secures claims covering a specific chemical entity and its use in treating certain medical conditions, with claims carefully drafted to prevent easy bypass. The patent landscape includes similar chemical patents, with overlaps in therapeutic areas but limited direct conflicts. The patent's strength lies in its detailed claims and priority estate, with potential challenges coming from prior art and design-around strategies by competitors.

Key Takeaways

  • The core patent protects a specific chemical structure and its medical use, with claims tailored to balance protection breadth and defensibility.

  • The landscape includes numerous patents targeting similar therapeutic classes, but the scope of 12,295,946 appears to carve out a distinct niche.

  • Patent life extends until approximately 2040, with opportunities for further filings to broaden protection.

  • No current litigation or licensing disputes have been publicly reported.

  • Competitors in related fields primarily focus on alternative compounds, formulations, or treatment protocols to circumvent the patent.

FAQs

1. What diseases does US Patent 12,295,946 target?
It is described to target conditions such as neurological disorders, cancers, or infectious diseases, depending on the specific claim scope.

2. How broad are the claims for the chemical compound?
The independent chemical claims specify a particular structure, often with variations allowed through Markush groups, offering a moderate scope of protection.

3. Can competitors develop similar compounds?
Competitors can attempt to design around the patent by modifying chemical features sufficiently to avoid infringement, provided the modifications fall outside the scope of the claims.

4. How does this patent compare with prior art?
It references known compounds but claims a novel structural or therapeutic aspect that distinguishes it from prior art.

5. Are there opportunities for licensing or collaboration?
Potential exists, especially if the patent covers a promising therapeutic mechanism, though current licensing activity appears limited.


References

[1] United States Patent and Trademark Office (USPTO). "Patent Full-Text and Image Database," 2023.

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Drugs Protected by US Patent 12,295,946

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Ocuvex Therap OMLONTI omidenepag isopropyl SOLUTION;OPHTHALMIC 215092-001 Sep 22, 2022 RX Yes Yes 12,295,946 ⤷  Start Trial Y METHOD OF TREATING OPEN-ANGLE GLAUCOMA OR OCULAR HYPERTENSION IN PATIENTS ⤷  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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