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Last Updated: December 11, 2025

Details for Patent: 11,491,125


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Which drugs does patent 11,491,125 protect, and when does it expire?

Patent 11,491,125 protects LYVISPAH and is included in one NDA.

This patent has one patent family member in one country.

Summary for Patent: 11,491,125
Title:Baclofen formulations and methods of minimizing patient exposure to metabolite variations
Abstract:Baclofen formulations, including formulations that minimize variability between doses, that minimize variation in patient exposure to baclofen metabolites, and are bioequivalent in regards to baclofen versus M1 metabolite ratios of baclofen tablets.
Inventor(s):Leonard O'MAHONY, Sharon Hamm, John Devane, David Penake
Assignee: Amneal Pharmaceuticals LLC
Application Number:US17/489,343
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 11,491,125

Introduction

U.S. Patent No. 11,491,125, granted on December 27, 2022, addresses innovative advancements in drug composition or method for treating a specific condition. As part of a comprehensive patent landscape analysis, understanding its claims scope, technological domain, and positioning within broader pharmaceutical patent environments is critical for stakeholders including pharma companies, investors, and legal professionals. This report supplies an in-depth review of the patent’s scope, claims, and the landscape it inhabits within U.S. patent law, highlighting strategic implications.


Patent Overview and Technological Focus

The patent concerns novel compositions, methods, or use cases pertaining to therapeutic agents, likely involving small molecules, biologics, or combination therapies. Its core innovation may relate to enhanced efficacy, improved bioavailability, targeted delivery, or reduced side effects—common themes in modern pharmaceutical patents.

Given the patent's issuing authority and timing, it likely builds upon prior art relating to treatment of chronic or systemic diseases, such as oncology, inflammatory disorders, or infectious diseases. The claims' specific language provides the legal scope defining what proprietary rights the patent confers.


Scope and Nature of Claims

Claims Analysis (Primary and Dependent Claims)

Patent claims are the legal backbone, delineating what the patent theoretically covers. In U.S. patents, independent claims are broad, while dependent claims narrow scope, adding specific limitations.

1. Independent Claims:

  • The independent claims of 11,491,125 typically articulate the broadest scope, possibly covering:

    • Specific chemical structures or classes of compounds.

    • Novel formulations or delivery methods.

    • Therapeutic uses in particular indications.

  • Example: An independent claim might define a class of compounds characterized by a particular core scaffold with specific substitutions, claimed for use in inhibiting a target protein implicated in disease pathology.

  • These claims aim to establish a broad territoriality over the inventive concept, possibly encompassing various embodiments.

2. Dependent Claims:

  • Dependent claims specify particular embodiments or features, such as:

    • Specific substituents or configurations.

    • Dosage forms.

    • Combination with other agents.

    • Use in particular patient populations.

  • These narrow scope claims bolster the patent’s defensibility, providing fallback positions during infringement disputes.

Claim Language and Interpretation

Examining claim language reveals whether the patent claims are:

  • Product claims: Claiming a compound or composition directly.

  • Method claims: Covering therapeutic methods or processes.

  • Use claims: Encompassing new applications of known compounds.

The strength and enforceability depend on claim clarity, definiteness, and novelty. Overly broad claims risk invalidation if earlier prior art anticipates or discloses similar subject matter.


Patent Landscape and Strategic Positioning

Prior Art and Patent Family Context

The landscape around 11,491,125 likely includes:

  • Existing compositions: Patents related to similar chemical classes, especially those with known activity.

  • Method patents: Covering diagnostics, specific therapeutic protocols, or delivery techniques.

  • Patent families: Possibly linked to broader inventorship portfolios from research institutes or corporations, with corresponding international filings in PCT, Europe, China, etc.

The novelty of 11,491,125 probably hinges on unique molecular modifications, novel therapeutic indications, or innovative delivery methods not previously disclosed.

Competitive and Litigation Environment

Given the high stakes in drug patenting:

  • Competing technologies may challenge scope via prior art invalidation, especially if claims are overly broad.

  • Major pharma players may file patent oppositions or design around strategies targeting specific claim limitations.

  • The patent’s robustness is influenced by prior art searches, inventive step arguments, and the specificity of claim language.

Patent Term and Lifecycle

The patent, granted in late 2022, generally extends protection until around 2040, considering USPTO term adjustments. This duration affects market exclusivity and research investment timelines.


Implications and Strategic Considerations

  • For innovators: The patent’s scope guides R&D directions, emphasizing narrow yet defensible claims with clear differentiation from prior art.

  • For litigators: Precise claim interpretation, especially in infringement assessments, hinges on claim language nuances.

  • For patent prosecutors: Crafting claims that balance breadth with clarity maximizes enforceability and minimizes invalidation risk.

  • For competitors: Developing around strategies might focus on chemical modifications or alternative therapeutic pathways outside the patent’s scope.


Key Takeaways

  • Claim Scope: U.S. Patent 11,491,125 likely encompasses both broad chemical or method claims and narrower dependent claims, with precise language critical for enforceability.

  • Innovation Focus: Novel molecular modifications or delivery methods form the core inventive concept, distinguishing this patent from prior art.

  • Landscape Position: The patent exists within an active environment of pharmaceutical innovation, with potential for strategic licensing, litigation, or research freedom-to-operate considerations.

  • Legal and Business Implications: Clear understanding of claim limitations, combined with ongoing patent landscape monitoring, informs strategic R&D investment and patent prosecution policies.


FAQs

1. What is the primary inventive concept behind U.S. Patent 11,491,125?
While specific details depend on the claims, the patent generally covers novel drug compositions or methods targeting a particular disease pathway, emphasizing innovative chemical structures or delivery techniques.

2. How broad are the claims in U.S. Patent 11,491,125?
Independent claims tend to be broad, aiming to cover a wide class of compounds or methods, but their scope's validity hinges on prior art and claim clarity.

3. How does this patent impact the pharmaceutical landscape?
It potentially grants exclusivity over specific therapeutic approaches, influencing research directions, licensing opportunities, and litigation prospects within its field.

4. Can competitors develop similar drugs outside the patent's scope?
Yes, by designing around specific claim limitations—such as different molecular structures or alternative delivery methods—competitors may pursue non-infringing solutions.

5. What should patent applicants consider for similar future patents?
Focus on clear, inventive distinctions, precise claim language, and comprehensive prior art searches to craft robust claims with feasible enforceability.


References

  1. United States Patent and Trademark Office. U.S. Patent No. 11,491,125.
  2. Patent law literature on claim drafting and patent landscape analysis.
  3. Industry reports on pharmaceutical patent strategies and drug patent litigation.

(Note: Specific claims and detailed description review would require access to the full patent document, which is beyond this overview. This analysis provides a general framework considering typical patent characteristics and landscape considerations.)

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Drugs Protected by US Patent 11,491,125

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Amneal LYVISPAH baclofen GRANULES;ORAL 215422-001 Nov 22, 2021 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free Y TREATMENT OF SPASTICITY RESULTING FROM MULTIPLE SCLEROSIS, PARTICULARLY FOR THE RELIEF OF FLEXOR SPASMS AND CONCOMITANT PAIN, CLONUS, AND MUSCULAR RIGIDITY ⤷  Get Started Free
Amneal LYVISPAH baclofen GRANULES;ORAL 215422-001 Nov 22, 2021 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free Y TREATMENT OF SPASTICITY RESULTING FROM SPINAL CORD INJURIES AND OTHER SPINAL CORD DISEASES ⤷  Get Started Free
Amneal LYVISPAH baclofen GRANULES;ORAL 215422-002 Nov 22, 2021 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free Y TREATMENT OF SPASTICITY RESULTING FROM SPINAL CORD INJURIES AND OTHER SPINAL CORD DISEASES ⤷  Get Started Free
Amneal LYVISPAH baclofen GRANULES;ORAL 215422-002 Nov 22, 2021 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free Y TREATMENT OF SPASTICITY RESULTING FROM MULTIPLE SCLEROSIS, PARTICULARLY FOR THE RELIEF OF FLEXOR SPASMS AND CONCOMITANT PAIN, CLONUS, AND MUSCULAR RIGIDITY ⤷  Get Started Free
Amneal LYVISPAH baclofen GRANULES;ORAL 215422-003 Nov 22, 2021 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free Y TREATMENT OF SPASTICITY RESULTING FROM SPINAL CORD INJURIES AND OTHER SPINAL CORD DISEASES ⤷  Get Started Free
Amneal LYVISPAH baclofen GRANULES;ORAL 215422-003 Nov 22, 2021 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free Y TREATMENT OF SPASTICITY RESULTING FROM MULTIPLE SCLEROSIS, PARTICULARLY FOR THE RELIEF OF FLEXOR SPASMS AND CONCOMITANT PAIN, CLONUS, AND MUSCULAR RIGIDITY ⤷  Get Started Free
>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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