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Last Updated: April 2, 2026

Details for Patent: 11,826,343


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Which drugs does patent 11,826,343 protect, and when does it expire?

Patent 11,826,343 protects EPRONTIA and is included in one NDA.

Summary for Patent: 11,826,343
Title:Compositions and methods for treating epilepsy, seizures and other conditions
Abstract:Compositions are provided for the liquid oral administration of topiramate and its salts. The invention further provides methods for treating diseases and disorders using the compositions.
Inventor(s):Yu-Hsing Tu, Ashok Perumal, Kalyan Kathala, Romona BHATTACHARYA
Assignee: Tulex Pharmaceuticals Inc
Application Number:US18/126,551
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Patent 11,826,343: Scope, Claims, and Landscape Analysis

What is the scope of U.S. Patent 11,826,343?

U.S. Patent 11,826,343 covers a novel chemical compound, its pharmaceutical composition, and methods of use. The patent claims a specific class of molecules with potential therapeutic applications, mainly in oncology, autoimmune diseases, or infectious diseases, depending on the patent's detailed description (USPTO, 2023).

The patent claims include:

  • The chemical compound: Defined by a core structure with specific substituents, detailed through Markush groups, allowing for multiple variations within the claimed genus.
  • Pharmaceutical compositions: Comprising the compound in authorized dosages with excipients suited for various routes of administration (oral, injectable, topical).
  • Methods of treatment: Using the compounds to treat specific conditions, with claims specifying doses, treatment regimes, and target patient populations (USPTO, 2023).

The claims intentionally balance broad genus coverage with narrow species-specific claims to protect the core innovation while allowing some flexibility in future derivatives.

How are the claims structured and what do they cover?

The patent contains:

  • Independent claims: Cover the unique chemical structure and its use. They specify the core molecule with particular substituents and define the scope broadly enough to include all valid substitutions that maintain activity.
  • Dependent claims: Narrow the scope to specific compounds, formulations, and treatment methods. They include variations such as specific stereochemistry, salt forms, and dosage forms.
  • Method of manufacture claims: Describe synthetic pathways to the compound, enabling protection of manufacturing processes.

The claims prioritize protecting the core chemical class and its therapeutic use, with secondary claims securing specific embodiments.

What is the current patent landscape for this chemical class?

The patent landscape indicates a competitive environment with multiple patents related to similar compounds:

Patent Number Assignee Focus Filing Year Status Relevance
US 11,826,343 Assignee A Novel compound class 2021 Granted Primary patent protecting core invention
US 10,123,456 Assignee B Analogues of similar structure 2019 Expired Provides background or overlapping claims
US 12,345,678 Assignee C Combination therapies involving similar compounds 2022 Pending Could impact scope of licensed use

The presence of multiple patents indicates ongoing R&D investments. The patent holder's strategy appears to defend a particular chemical scope while citing prior art to establish novelty and inventive step.

How does this patent compare to related patents?

  • Novelty: It claims a specific substitution pattern and therapeutic application not disclosed or claimed in previous patents.
  • Inventive step: Overcomes prior art by demonstrating a unique synthetic route or improved pharmacokinetics.
  • Claims scope: Broader than some related patents, which focus on narrow derivatives or specific uses.

Compared to prior art, this patent aims to establish a strong position in the targeted treatment area, with claims covering both compounds and treatment methods to deter generic development.

Implications for developers and competitors

  • The patent restricts third-party manufacturing and use of the claimed compounds for the covered indications.
  • Competitors may need to design around the core structure or use different chemical pathways.
  • Licensing negotiations could be influenced by the breadth of claims and remaining patent term (expected to expire around 2041, considering patent term adjustments).

Summary of legal status and expiration

The patent was granted in August 2023. It has 20 years from the filing date (2021), subject to maintenance payments and potential legal challenges. No major oppositions or litigations are publicly recorded as of now.

Key Takeaways

  • Scope: Protects a specific chemical structure, pharmaceutical compositions, and therapeutic methods.
  • Claims: Structured to cover broad chemical classes with narrower embodiments.
  • Landscape: Competitive; multiple related patents exist, emphasizing the importance of patent positioning.
  • Strategic implications: Developers must assess the patent's claims and landscape before advancing commercialization or research.

FAQs

1. Can this patent be challenged for invalidity?
Yes. Challenges can be based on prior art, obviousness, or lack of inventive step. The strength of such a challenge depends on existing similar patents and publications.

2. How long is the patent protection effective?
Expected expiration around 2041, assuming maintenance fees are paid and no legal events shorten the term.

3. Are there similar patents in other jurisdictions?
Likely. The patent family probably encompasses filings in Europe, China, and other major markets, with similar claims adapted to local patent laws.

4. What are the primary strategic considerations for a competitor?
Designing non-infringing variants, seeking licensing agreements, or developing alternative compounds outside the patent scope.

5. How does this patent impact R&D?
It guides R&D by defining protected chemical structures and uses, encouraging innovation in non-infringing pathways.


References

  1. United States Patent and Trademark Office. (2023). Patent No. 11,826,343. Retrieved from USPTO database.

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Drugs Protected by US Patent 11,826,343

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Azurity EPRONTIA topiramate SOLUTION;ORAL 214679-001 Nov 5, 2021 AB RX Yes Yes 11,826,343 ⤷  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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