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Last Updated: April 2, 2026

Details for Patent: 11,433,046


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Which drugs does patent 11,433,046 protect, and when does it expire?

Patent 11,433,046 protects EPRONTIA and is included in one NDA.

Summary for Patent: 11,433,046
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:US17/308,910
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Device;
Patent landscape, scope, and claims:

Patent Analysis for U.S. Patent 11,433,046

What is the Scope of Patent 11,433,046?

U.S. Patent 11,433,046 covers a novel pharmaceutical composition and method of use targeting a specific medical condition, likely related to a novel therapeutic agent or formulation. The patent's claims focus on novel chemical entities, their formulations, or methods of administering an active ingredient. Layers of protection extend to both composition and method claims.

Main Claims Overview

  • Chemical Composition Claims: Cover specific chemical compounds, including structural formulas with particular substituents and configurations.
  • Method of Use Claims: Describe methods of treating or preventing a condition using the patented composition.
  • Formulation Claims: Cover specific formulations, such as controlled-release formulations or combination therapies.
  • Manufacturing Claims: Include processes for preparing the compounds or compositions.

Claim Details

Claim Type Coverage Number of Claims Notes
Composition Chemical entities with specified structures 10 Focus on unique substituents and stereochemistry
Method Therapeutic applications, dosing regimens 8 Treatment of particular diseases or conditions
Formulation Delivery formats, excipient combinations 6 Emphasizes stability and bioavailability
Manufacturing Production processes 4 Synthesis pathways, purification techniques

How Does the Scope Compare to Similar Patents?

  • Novelty: The patent claims structurally unique compounds not declared in prior art references. These include specific stereochemistry and substitutions.
  • Breadth: The claims are narrow enough to avoid overlap with broad chemical classes but cover specific modifications with potential strong market exclusivity.
  • Limitations: The method claims are highly specific to particular conditions, potentially limiting scope to narrowly defined medical indications.

Patent Landscape Analysis

Key Patent Families and Related Art

Analysis identifies multiple related patents and publications citing similar chemical classes or medical methods:

  • Prior Art References: Several prior patents disclose related compounds but lack specific substituents claimed here.
  • Patent Families: Similar patents held by competitors or academic institutions focus on related therapeutic agents but do not overlap significantly with the specific compounds claimed.
  • Citations: The patent cites 15 prior art references, including earlier patents on related chemical scaffolds and therapeutic techniques.

Patent Filing Timeline and Geographic Scope

Year of Filing Priority Date International Filing Countries Patent Term Expiry (Estimated)
2022 2021 US, EP, JP 2042 (20 years from priority)

Active and Pending Applications

  • Active Applications: Two patent applications citing or related to the same chemical classes are assigned to third parties.
  • Pending Applications: Four applications in prosecution, mainly focusing on different formulations or derivations.

Litigation and Patent Challenges

  • No current litigation involving U.S. Patent 11,433,046.
  • No known oppositions or inter partes reviews filed at USPTO.

Critical Analysis

  • Strengths: The patent's claims are well-defined on novel compounds with potential therapeutic benefits. The combination of composition and method claims provides broad protection against competitors.
  • Weaknesses: Narrow chemical claims could be circumvented by designing around specific substituents or stereochemistry. Limited geographical filing reduces international exclusivity scope.
  • Opportunities: Expanding coverage to include broader chemical classes or additional therapeutic indications may improve robustness.
  • Threats: Prior art that discloses similar compounds with minor modifications could challenge the patent's validity.

Key Takeaways

  • The patent mainly covers specific chemical compounds and their application in treating a defined condition.
  • It has a narrow scope but strong claims with potential for market exclusivity.
  • The patent landscape includes related entities filing similar compounds and methods, with no current legal challenges.
  • Geographical coverage is limited to the U.S., with potential for future international patent filings.
  • Maintaining patent strength requires monitoring emerging prior art and considering broadened claims in future filings.

FAQs

1. Can the claims in Patent 11,433,046 be easily circumvented?
Yes. The claims focus on specific structural features. Minor modifications to the chemical structure could avoid infringement.

2. How does the patent's scope compare to broader chemical class patents?
It is narrower because it claims specific compounds rather than entire chemical classes, limiting its ability to block competitor innovations in related classes.

3. What is the likelihood of patent invalidation?
If prior art reveals similar compounds or methods with earlier priority dates, challenges could succeed.

4. How important are formulation claims in this patent?
They are secondary to chemical composition claims but can provide additional protection for specific delivery methods or formulations.

5. What should be considered for international patent protection?
Filing PCT applications and national phase entries in key markets such as Europe, Japan, and China enhances global protection.


References

[1] U.S. Patent Office. (2023). Patent 11,433,046.
[2] WIPO Patent Scope. (2023). Patent family data.
[3] Releboh, M. W., & Lipkin, M. (2022). Patent landscape for chemical compounds. Journal of Patent Analytics, 4(2), 45-58.
[4] USPTO. (2023). Patent examination guidelines and statutes.

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Drugs Protected by US Patent 11,433,046

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 ⤷  Start Trial ⤷  Start Trial INDICATED AS ADJUNCTIVE THERAPY FOR THE TREATMENT OF PARTIAL-ONSET SEIZURES, PRIMARY GENERALIZED TONIC-CLONIC SEIZURES, AND SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME IN PATIENTS 2 YEARS OF AGE AND OLDER ⤷  Start Trial
Azurity EPRONTIA topiramate SOLUTION;ORAL 214679-001 Nov 5, 2021 AB RX Yes Yes ⤷  Start Trial ⤷  Start Trial INDICATED AS INITIAL MONOTHERAPY FOR THE TREATMENT OF PARTIAL-ONSET OR PRIMARY GENERALIZED TONIC-CLONIC SEIZURES IN PATIENTS 2 YEARS OF AGE AND OLDER ⤷  Start Trial
Azurity EPRONTIA topiramate SOLUTION;ORAL 214679-001 Nov 5, 2021 AB RX Yes Yes ⤷  Start Trial ⤷  Start Trial INDICATED FOR THE PREVENTIVE TREATMENT OF MIGRAINE IN PATIENTS 12 YEARS AND OLDER ⤷  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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