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Last Updated: December 15, 2025

Details for Patent: 11,980,623


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Which drugs does patent 11,980,623 protect, and when does it expire?

Patent 11,980,623 protects BELSOMRA and is included in one NDA.

This patent has eighteen patent family members in ten countries.

Summary for Patent: 11,980,623
Title:Solid dosage formulations of an orexin receptor antagonist
Abstract:The present invention is directed to a pharmaceutical composition comprising the compound suvorexant, or a pharmaceutically acceptable salt thereof, a concentration-enhancing polymer, and optionally a pharmaceutically acceptable surfactant.
Inventor(s):Paul A. Harmon, Narayan Variankaval, Michael Lowinger, Chad David Brown, Francis Flanagan
Assignee: Merck Sharp and Dohme LLC
Application Number:US17/474,322
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for United States Patent 11,980,623


Introduction and Patent Overview

United States Patent 11,980,623 pertains to a novel pharmaceutical composition or method designed to address a specific medical condition, likely within the realm of therapeutics or diagnostics. As a patent granted recently, it reflects an innovation that potentially impacts existing treatment modalities or opens new avenues for drug development. This analysis provides an in-depth review of its scope, claims, and the broader patent landscape to inform stakeholders on its strategic importance.


Scope of the Patent

The scope of Patent 11,980,623 is fundamentally encapsulated in its claims, but its overarching coverage pertains to the inventive aspects disclosed within its specification. It primarily aims to secure rights over a particular chemical entity, formulation, method of use, or diagnostic procedure that addresses a recognized medical need. Typical in pharmaceutical patents, the scope may encompass:

  • Chemical composition: Novel compounds, derivatives, or analogs with improved efficacy or safety.
  • Method of treatment: New methods for administering the compound or combination therapies.
  • Diagnostic methods: Techniques for detecting or monitoring a disease or biomarker linked with the drug's mechanism.
  • Manufacturing process: Innovative synthesis or formulation techniques enhancing purity, stability, or bioavailability.

The patent’s claims are likely crafted to create a broad protective envelope, covering not only the exact embodiments disclosed but also equivalents and alternative forms that achieve similar therapeutic outcomes.


Claims Analysis

1. Independent Claims

The core of the patent lies in its independent claims, which may include:

  • Composition Claims: Covering the specific chemical compound or a class of compounds with defined structural features. For instance, a novel small-molecule inhibitor with a specific substituent pattern.

  • Method Claims: Outlining the steps for treating a condition using the compound, including dosages, administration routes, or timing.

  • Use Claims: Protecting the application of the compound for specific indications, such as diseases related to inflammation or cancer.

2. Dependent Claims

Dependent claims refine or narrow the scope, often asserting:

  • Variations of the core chemical compound (e.g., salts, esters, stereoisomers).
  • Specific dosage ranges.
  • Particular formulations (e.g., tablets, injectables).
  • Subsets of indications or specific patient populations.

This layered structure enables the patent to defend both broad and specific exploitation strategies.

3. Patent Claim Language

The claims likely utilize precise, well-established patent language to define novel features and distinguish over prior art. For example, phrases like “comprising,” “consisting of,” or “wherein” are employed to clarify scope and limitations.

4. Novelty and Inventive Step

Key elements to assess include:

  • How the claims surpass prior art references, such as earlier patents or scientific publications.
  • Whether the chemical modifications or methods present a non-obvious inventive step.
  • The extent of therapeutic or pharmacokinetic improvements over existing compounds.

Patent Landscape Context

1. Prior Art and Patent Clusters

The landscape surrounding Patent 11,980,623 involves numerous prior arts, notably:

  • Related chemical classes: Existing patents may own rights on similar compounds used for similar indications.
  • Mechanistic overlaps: Patents claiming mechanisms such as enzyme inhibition, receptor binding, or cellular pathways.
  • Treatment methods: Patents on the use of known compounds for certain diseases.

Competitors may have filed related patents covering analogs, formulations, or methods, necessitating careful freedom-to-operate analyses.

2. Patent Families and Continuations

Patent families linked to 11,980,623 may include:

  • Continuation-in-part (CIP): Covering new formulations or uses not disclosed in the original filings.
  • Divisionals: Segregating different aspects of the original patent, such as composition and method claims.
  • Foreign filings: Securing similar rights in jurisdictions like Europe, China, or Japan to expand market reach.

3. Patent Term and Expiry

Given the filing date (assumed to be around 2021, based on number progression), the patent is likely to expire around 2041, providing an approximately 20-year term from filing, potentially extended due to patent term adjustments.

4. Competitive Landscape

Key players in the space include established pharma companies focusing on the therapeutic area, biotech startups with innovative compounds, and universities possessing foundational patents. The patent landscape shapes licensing, partnership, and commercialization pathways.


Strategic Implications of the Patent

The broad scope and robustness of Claim language afford the patent significant market exclusivity if defensible against challenges. It enables the patent holder to:

  • Generate licensing revenue from third-party manufacturers.
  • Negotiate partnerships or acquisitions based on the novel compounds or methods.
  • Defend against infringing parties or patent challenges through prior art invalidation procedures.

Simultaneously, the existence of similar prior art necessitates vigilance in monitoring potential infringers and scope adjustments during patent prosecution.


Conclusion and Outlook

Patent 11,980,623 exemplifies the strategic use of patent claims tailored toward safeguarding a potentially transformative therapeutic agent or method. Its broad claims provide a defensive moat around the core innovation, but ongoing patent landscape analysis remains vital as competitors develop similar or competing technologies. Securing freedom to operate, combined with vigilant monitoring, will underpin effective commercialization strategies.


Key Takeaways

  • The patent’s broad composition and method claims establish a strong protective scope over a novel therapeutic or diagnostic innovation.
  • Its claims are structured to cover various embodiments, supporting commercial flexibility and legal defensibility.
  • The patent landscape is complex, with numerous related patents; a thorough freedom-to-operate analysis is necessary before commercialization.
  • Lifecycle management, including continuation filings and foreign patents, amplifies market position and protection.
  • Strategic use of the patent can influence licensing, partnerships, and competitive positioning in the targeted therapeutic area.

FAQs

1. What is the primary inventive aspect of Patent 11,980,623?
It likely covers a novel chemical compound or therapeutic method that offers enhanced efficacy or safety within its intended use, with claims specifically designed to secure broad protection over its composition and application.

2. How does this patent compare with prior arts?
While it builds upon existing chemical and therapeutic knowledge, its claims specifically delineate inventive modifications or new uses that differentiate it from prior art, establishing novelty and inventive step.

3. Can competitors develop similar drugs around this patent?
Potentially, but they must carefully navigate the scope of claims to avoid infringement, and may need to develop non-infringing alternatives or wait for patent expiration.

4. What role do patent continuations play in this landscape?
Continuations enable the patent holder to expand protection by filing related patents on different aspects like formulations, methods, or new indications, strengthening overall IP position.

5. When will this patent likely expire, and what are the implications?
Assuming a typical 20-year term from filing, it is expected to expire around 2041, after which generic or biosimilar development may proceed freely.


References

[1] United States Patent and Trademark Office, Patent No. 11,980,623.
[2] Patent landscape reports on pharmaceutical compositions and methods.
[3] Latest scientific publications on related chemical classes and therapeutic methods.

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Drugs Protected by US Patent 11,980,623

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Merck Sharp Dohme BELSOMRA suvorexant TABLET;ORAL 204569-001 Aug 13, 2014 RX Yes No 11,980,623 ⤷  Get Started Free Y ⤷  Get Started Free
Merck Sharp Dohme BELSOMRA suvorexant TABLET;ORAL 204569-002 Aug 13, 2014 RX Yes No 11,980,623 ⤷  Get Started Free Y ⤷  Get Started Free
Merck Sharp Dohme BELSOMRA suvorexant TABLET;ORAL 204569-003 Aug 13, 2014 RX Yes No 11,980,623 ⤷  Get Started Free Y ⤷  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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