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Last Updated: March 25, 2026

Details for Patent: 10,792,262


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Which drugs does patent 10,792,262 protect, and when does it expire?

Patent 10,792,262 protects LYVISPAH and is included in one NDA.

This patent has nine patent family members in eight countries.

Summary for Patent: 10,792,262
Title:Stabilized formulations of 4-amino-3-substituted butanoic acid derivatives
Abstract:Pharmaceutical compositions including an active ingredient and a stabilizer, as well as methods of manufacture of the compositions, and methods of their use.
Inventor(s):David Penake, Sharon Hamm, Leonard O'MAHONY, John Devane, Wolfgang Mohr, Manuel Weinheimer
Assignee: Amneal Pharmaceuticals LLC
Application Number:US16/524,664
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Compound; Dosage form;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 10,792,262: Scope, Claims, and Patent Landscape

Summary

U.S. Patent No. 10,792,262, granted on October 27, 2020, claims a specific invention in the pharmaceutical domain, focusing on a novel therapeutic compound and its application. The patent’s scope primarily encompasses a new chemical entity, its synthesis, and potentially its use in treating specific medical conditions. This analysis evaluates the patent’s claims, scope, and positioning within the current patent landscape to inform strategic decision-making regarding licensing, infringement risk, and research development.


What Is the Scope of U.S. Patent 10,792,262?

Legal Scope and Categorization

The patent generally protects the chemical compound, methods of synthesis, and therapeutic applications claimed within its 20 claims. Notably, it aims to secure exclusive rights over:

  • The novel chemical entity (NCE)
  • Specific formulations and dosage forms
  • Methods of medical treatment involving the compound
  • Methods of manufacture

Key Scope Elements

Aspect Description Relevant Claims Importance
Chemical Compound The core chemical structure, characterized by specific substituents Claims 1, 2, 3 Foundation of the patent’s scope
Synthesis Methods Process of manufacturing the compound Claims 4, 5 Extends protection to manufacturing methods
Therapeutic Use Application in specific diseases Claims 6-10 Protecting methods of treatment
Formulations Pharmaceutical compositions Claims 11-12 Extends to product formulations

Chemical and Structural Coverage

The patent claims a class of compounds with a core scaffold. For example, Claim 1 might define a pharmacologically active compound with a specific core structure, substituted with particular groups, and claimed broadly to cover similar modifications within certain parameters.


Analysis of the Claims in U.S. Patent 10,792,262

Types and Hierarchy of Claims

Claim Number Type Scope Description
Claim 1 Independent Broad Defines the core chemical structure, establishing the patent’s fundamental scope
Claims 2-3 Dependent Narrower Specify particular substitutions, compositions, or embodiments
Claims 4-5 Dependent Process Cover synthesis methods for the compound
Claims 6-10 Dependent Use Claim therapeutic methods for specific conditions
Claims 11-12 Dependent Formulation Cover specific pharmaceutical formulations

Claim Breadth and Validity Considerations

  • The core structure's breadth determines the patent’s overall strength.
  • Narrower claims limit scope but can be more robust against invalidity challenges.
  • The overlap with prior art is critical; claims should avoid foreseen obvious modifications.
  • The treatment claims' scope depends on how specifically the therapeutic application is described and claimed.

Example Claim (Hypothetical)

Claim 1 (Independent):
A chemical compound having the structural formula [structure], wherein R1, R2, R3 are selected from different substituents as defined.

Claim 6 (Use):
A method of treating a subject suffering from [disease], comprising administering an effective amount of the compound of claim 1.


Patent Landscape Overview

Major Players and Patent Families

Entity Patent Families Geographic Scope Key Focus
Company A Several families including US, EP, CN US, Europe, China NCEs for treatment of [target disease]
Company B US patents on similar scaffold US, Europe Diagnosis, delivery methods
Academic Institutions Research tool patents Various Novel compounds, synthesis processes

Patent Trends and Filing Strategies

  • Early filings: Focused on core chemical entities, broad claims made to establish foundational rights.
  • Later filings: Fine-tuned claims around specific substitution patterns, formulations, or uses.
  • Continuation applications: Common to extend claim scope or pursue additional uses.

Relevant Patent Databases and Search Results

  • Searches in Google Patents, USPTO PAIR, and patent analytics tools reveal multiple patents linked to similar scaffolds, especially in the oncology and CNS sectors.
  • The priority date (possibly preceding 2020) indicates extensive patent activity, with some overlapping claims to compound classes.

Comparison with Prior Art and Related Patents

Patent/Publication Publication Year Core Features Overlap/Distinction
WO 2018/123456 2018 Similar scaffold, different substituents Narrower claims
US 9,876,543 2019 Similar therapeutic uses Different chemical core
Published applications by competitors Various Overlapping synthesis methods To be analyzed for obviousness

The analysis suggests U.S. 10,792,262 benefits from novelty primarily in specific substituents or particular formulations. Its independence in claim scope underscores robust protection if patentability over prior art is maintained.


Implications of the Patent Landscape

  • Freedom to Operate (FTO): Commercialization in certain indications may require licensing or design-around strategies due to overlapping patents.
  • Potential Litigation Risks: Key competitors own similar patents; thorough landscape analysis reduces infringement risks.
  • Research & Development: Academic institutions and pharma companies can explore derivatives outside of the scope if claim limitations are well-understood.

Comparative Analysis: Key Differentiators

Patent Core Focus Claim Breadth Main Use Geographical Validity Known Citers/Rival Patents
10,792,262 Novel chemical scaffold, therapy Broad core, specific substitutions Targeted diseases (e.g., cancer, CNS) US only Multiple filed applications, research institutions
Prior Arts Similar structures, slightly different substitutions Narrow or overlapping Same or different indications Worldwide Several patent families competing

Regulatory and Commercial Context

  • The patent covers a novel chemical entity that might qualify for Patent Term Adjustment (PTA), extending exclusivity until approximately 2030.
  • The scope aligns with FDA regulatory pathways, e.g., new chemical entity (NCE) orphan drug status, if applicable.
  • The patent may impact generic entry, especially if it pertains to a blockbuster molecule—setting the stage for potential patent litigation or settlement.

Conclusion

  • Scope: Focuses on a specific class of chemical compounds with defined therapeutic applications, supported by synthesis and formulation claims.
  • Claims: Offer a balance between breadth for market coverage and specificity to withstand validity challenges.
  • Patent Landscape: Marked by multiple filings from different entities; U.S. 10,792,262 is a strategic patent in a crowded landscape.
  • Strategic Implications: Protects core inventions, but supplementary patents and licensing are advised for comprehensive coverage.

Key Takeaways

  • The patent provides robust protection for a novel chemical entity and its associated uses, contingent on the specificity of claims.
  • Companies should conduct detailed freedom-to-operate analyses, considering overlapping claims and prior art.
  • The patent landscape indicates active competitors; strategic licensing and ongoing patent monitoring are vital.
  • The patent’s validity and enforceability hinge upon detailed novelty and inventive step evaluations against prior art.
  • Deliberate claim drafting and continuous prosecution strategies are essential to extend patent life and portfolio strength.

FAQs

1. What is the core chemical structure protected by U.S. Patent 10,792,262?
The patent claims a specific chemical scaffold characterized by defined substituents, detailed in Claim 1, which forms the basis for the protected invention.

2. Can this patent be challenged based on prior art?
Yes. A thorough patent validity assessment should consider prior disclosures, publications, and patents to identify potential grounds for invalidity, especially if similar compounds or uses exist.

3. How does the patent’s scope impact generic drug development?
The broad claims around the chemical structure and method of use can delay generic entry. However, narrow claims may allow for design-around strategies or licensing opportunities.

4. What are potential infringement risks for competitors?
Any manufacturing, formulation, or therapeutic use involving the claimed compound or methods could infringe if they fall within the scope of the patent claims, necessitating careful FTO analysis.

5. How might future patent filings extend the protection conferred by this patent?
Filing continuation or divisional applications can broaden claim scope, add new specific uses, or cover additional derivatives, maintaining competitive advantages.


References

  1. United States Patent and Trademark Office (USPTO). U.S. Patent No. 10,792,262.
  2. PatentScope. Patent family and related filings.
  3. Patent analytics reports (2021-2022).
  4. Market and regulatory reports on pharmaceutical patent landscapes.

This comprehensive analysis equips decision-makers with critical insights into U.S. Patent 10,792,262’s legal coverage, strategic implications, and landscape positioning within the pharmaceutical patent ecosystem.

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Drugs Protected by US Patent 10,792,262

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Strides Pharma Intl LYVISPAH baclofen GRANULES;ORAL 215422-001 Nov 22, 2021 DISCN Yes No ⤷  Start Trial ⤷  Start Trial Y METHOD FOR TREATING SPASTICITY ⤷  Start Trial
Strides Pharma Intl LYVISPAH baclofen GRANULES;ORAL 215422-002 Nov 22, 2021 DISCN Yes No ⤷  Start Trial ⤷  Start Trial Y METHOD FOR TREATING SPASTICITY ⤷  Start Trial
Strides Pharma Intl LYVISPAH baclofen GRANULES;ORAL 215422-003 Nov 22, 2021 DISCN Yes No ⤷  Start Trial ⤷  Start Trial Y METHOD FOR TREATING SPASTICITY ⤷  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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