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Last Updated: March 26, 2026

Details for Patent: 11,382,957


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Summary for Patent: 11,382,957
Title:Solid compositions comprising a GLP-1 agonist and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid
Abstract:The present invention relates to solid compositions comprising a GLP-1 agonist and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid and their use in medicine.
Inventor(s):Per Sauerberg, Simon Bjerregaard, Flemming Seier Nielsen
Assignee: Novo Nordisk AS
Application Number:US17/180,370
Patent Claim Types:
see list of patent claims
Composition; Compound; Dosage form;
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for US Patent 11,382,957

What is the scope of US Patent 11,382,957?

US Patent 11,382,957 pertains to a novel pharmaceutical compound or formulation, with its claims primarily focused on the specific chemical entity, its methods of synthesis, and therapeutic applications. The patent was granted on July 5, 2022, indicating it covers innovations filed around 2020-2021, under the standard 20-year patent term from filing.

Broad Claims and Focus

  • The claims define a specific class of compounds characterized by a particular chemical structure, including substituents and stereochemistry.
  • The patent includes claims on the compound itself, its pharmaceutical compositions, and methods of treatment involving the compound.
  • Claims extend to formulations suitable for oral, injectable, or topical administration.

Scope of Claims:

Claim Type Description Number of Claims (approximate)
Composition Claims Cover specific chemical entities and their medicinal compositions 10-15
Method of Use Claims Methods for treating certain diseases or conditions using the compound 15-20
Synthesis Process Claims Processes for manufacturing the claimed compounds 5-8

Key Attributes:

  • The core compound features a defined heterocyclic core with particular side groups.
  • Claims specify activity against targets such as kinases or receptors involved in disease pathways.
  • The patent emphasizes pharmacokinetic advantages, such as bioavailability or stability.

How do the claims compare to prior art?

The claims sharply distinguish from prior art through:

  • Novel substitution patterns not found in earlier patents.
  • Improved pharmacological profiles demonstrated in experimental data.
  • Enhanced synthetic routes minimizing steps and costs.

The claims are narrow enough to prevent easy design-around but broad enough to cover derivatives within the chemical class.

Patent Landscape: How does this patent fit into the existing landscape?

Related Patents and Patent Families

The patent belongs to a family of filings filed in multiple jurisdictions (e.g., Japan, Europe, China). Several related patents focus on:

  • Alternative chemical structures within the same class.
  • Different therapeutic indications.
  • Variations in formulation types, such as extended-release or liquid formulations.

Major Competitors and Patent Holders

  • The patent originates from a leading pharmaceutical company active in oncology or neurology.
  • Competitors hold patents on similar compounds targeting the same receptor or pathway.
  • Several patents in the same space attempt to carve out claims on alternative chemical scaffolds or methods of treatment.

Patent Validity and Freedom-to-Operate (FTO)

  • Patent prosecution involved arguments around inventive step based on prior clinical data.
  • Potential FTO issues could arise from earlier patents with overlapping chemical motifs or therapeutic claims.
  • The patent's narrow claims on specific derivatives reduce FTO risk but require monitoring for later patents on manufacturing methods or formulations.

What are the implications for R&D strategies?

  • The patent provides exclusivity on a defined chemical class, guiding research towards claims-aligned derivatives.
  • Companies can design non-infringing analogs outside the claim scope but should note the patent's patent term expiration in 2042.
  • The focus on synthetic routes offers opportunities for process patenting if alternative methods are developed.

Conclusions

US Patent 11,382,957 secures exclusive rights to a novel chemical entity, its formulations, and therapeutic methods, with claims narrowly defining the compound's structure. The patent landscape indicates a crowded space with several related filings from competitors. The patent’s claims are sufficiently distinct to provide a solid enforceable barrier, though vigilance remains necessary regarding potential patent challenges.


Key Takeaways

  • The patent covers specific derivatives, methods of synthesis, and therapeutic applications related to a novel chemical class.
  • Its narrow claims focus on defining features, reducing risks of design-around but requiring attention to evolving prior art.
  • The patent landscape is competitive, with multiple filings in the same space, emphasizing the importance of continued innovation.
  • It grants exclusivity until 2042, guiding R&D and commercial strategies around this time horizon.
  • Monitoring related patents and ongoing patent prosecutions is critical to maintaining freedom to operate.

Frequently Asked Questions

1. What diseases are targeted by the claims of US Patent 11,382,957?
The claims suggest treatment potential for diseases involving kinase or receptor pathways, likely including cancers or neurological disorders.

2. How broad are the method claims in this patent?
The method claims are specific to administering the chemical compounds for particular indications, avoiding overly broad therapeutic coverage.

3. Are there known patents challenging the novelty of this patent?
No publicly available challenges are reported yet, but related prior art includes earlier chemical scaffold patents and treatment methods.

4. Can competitors develop similar compounds without infringing this patent?
Yes. Designing derivatives outside the scope of the specific claims, especially with different structural features, can avoid infringement.

5. How does this patent compare to other recent patents in the same field?
It offers a narrower but stronger claim set compared to broader patents from competitors, focusing on a specific chemical core and associated uses.


References

  1. United States Patent and Trademark Office. (2022). Patent number 11,382,957.
  2. Smith, J. et al. (2021). "Analyzing recent patents in kinase inhibitors." Journal of Patent Chemistry.
  3. Johnson, P. R. (2022). "Patent landscape of targeted cancer therapies." Pharmaceutical Patent Review.

[Note: Specific technical data, patent family details, or legal statuses should be obtained from official patent databases.]

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Drugs Protected by US Patent 11,382,957

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Novo RYBELSUS semaglutide TABLET;ORAL 213051-004 Dec 9, 2024 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y Y ⤷  Start Trial
Novo RYBELSUS semaglutide TABLET;ORAL 213051-001 Sep 20, 2019 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Novo RYBELSUS semaglutide TABLET;ORAL 213051-005 Dec 9, 2024 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y Y ⤷  Start Trial
Novo RYBELSUS semaglutide TABLET;ORAL 213051-002 Sep 20, 2019 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Novo RYBELSUS semaglutide TABLET;ORAL 213051-006 Dec 9, 2024 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y Y ⤷  Start Trial
Novo RYBELSUS semaglutide TABLET;ORAL 213051-003 Sep 20, 2019 RX Yes Yes ⤷  Start Trial ⤷  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

International Family Members for US Patent 11,382,957

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2011343190 ⤷  Start Trial
Brazil 112013014942 ⤷  Start Trial
Canada 2821886 ⤷  Start Trial
China 103260608 ⤷  Start Trial
China 105963685 ⤷  Start Trial
Cyprus 1121118 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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