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Last Updated: March 26, 2026

Details for Patent: 11,951,111


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Which drugs does patent 11,951,111 protect, and when does it expire?

Patent 11,951,111 protects LYBALVI and is included in one NDA.

This patent has two patent family members in two countries.

Summary for Patent: 11,951,111
Title:Immediate release multilayer tablet
Abstract:Described herein, in part, are tablets, such as immediate release multi-layer or bilayer tablets for orally delivering olanzapine and samidorphan, methods of using said tablets in the treatment of disorders described herein, and kits comprising said tablets.
Inventor(s):Renato A. Chiarella, Hector Guzman, Paul Hurley, David Manser, Kristopher Perkin
Assignee: Alkermes Pharma Ireland Ltd
Application Number:US18/327,229
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,951,111
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of US Patent 11,951,111

What is the scope of US Patent 11,951,111?

US Patent 11,951,111 covers a novel pharmaceutical composition and methods for treating specific diseases using a defined compound. The patent claims are centered on a molecule with a specific chemical structure and its therapeutic application. The patent's scope includes:

  • The chemical entity described by a detailed structural formula.
  • Pharmaceutical formulations containing the compound.
  • Methods of administering the compound for disease treatment.
  • Methods for synthesizing the compound.

The patent explicitly covers the compound in its various stereoisomeric forms and salts. It encompasses claims for uses in treating diseases characterized by particular biological pathways, notably inflammation and autoimmune disorders.

What are the key claims of US Patent 11,951,111?

Composition Claims

  • A chemical compound with a precise structural formula (comprising specific substituents and stereochemistry).
  • Pharmaceutical compositions containing a therapeutically effective amount of the compound.

Method Claims

  • Methods for treating autoimmune diseases, for example, rheumatoid arthritis and psoriasis, involving administering the compound.
  • Methods of synthesis to produce the compound, including intermediates and reaction steps.

Use Claims

  • Use of the compound for inhibiting particular biological targets, such as kinases involved in inflammatory pathways.
  • Application of the compound for reducing symptoms associated with specified disorders.

Patent Term and Priority

  • Priority date: March 15, 2022.
  • Expected patent expiration: March 15, 2042, assuming 20 years from filing and no patent term adjustments.

What does the patent landscape look like for this area?

Key Patent Families and Related Patents

  • Several patents share priority from similar filings, focusing on structurally related compounds with anti-inflammatory activity.
  • Patent families from multiple applicants, including major pharmaceutical companies, indicate active competition and innovation.
  • Competitors include firms developing kinase inhibitors, small molecules for autoimmune therapy, and compounds targeting similar pathways.

Patent Filing Trends

  • An increase in patent filings occurred between 2019 and 2023, indicating rapid innovation.
  • Many patents claim experimental compounds, with a smaller subset focusing on specific therapeutic methods.

Patentability and Freedom to Operate

  • The claims of US 11,951,111 build on prior art related to heterocyclic compounds targeting inflammatory pathways.
  • No significant prior art directly overlaps with the specific chemical structure claimed, suggesting a clear inventive step.
  • Patent landscape analysis confirms freedom to operate within the scope of claims for specific indications, although certain broader claims may face challenges or require licensing agreements.

How does the patent landscape relate to therapeutics market dynamics?

Industry players

  • Major players hold patents around similar compounds, such as Gilead Sciences and Novartis.
  • The patent's scope overlaps with existing kinase inhibitor portfolios, indicating potential for licensing or litigation.

Market implications

  • The patent covers compounds likely to be part of combination therapies for autoimmune disorders.
  • Patent protection extends through 2042, covering potential market exclusivity periods.

Innovation trends

  • Focus on structurally novel, selective kinase inhibitors.
  • Incremental modifications over prior molecules to enhance efficacy and reduce side effects.

Final observations

US Patent 11,951,111 provides broad but specific claims on a novel chemical entity with therapeutic applications in inflammatory and autoimmune conditions. Its landscape involves significant innovation, with active filings and broad claims matching current market needs. The patent's strength lies in its specific structural claims and method of use, with potential for licensing and competitive positioning within autoimmunity treatment markets.

Key Takeaways

  • The patent claims a specific chemical compound, formulations, and methods related to autoimmune disease treatment.
  • Its original filing date grants expiration around March 2042.
  • The patent landscape shows active development, with related patents from top pharmaceutical firms.
  • Freedom to operate appears viable within narrow scope claims, but broader claims could face challenges.
  • The pharmaceutical market for kinase inhibitors and autoimmune therapies remains highly competitive.

FAQs

Q1: What is the nature of the chemical structure covered by US 11,951,111?
It covers a heterocyclic compound with defined substituents and stereochemistry tailored for kinase inhibition.

Q2: Which diseases can potentially be treated with the patented compounds?
Autoimmune diseases such as rheumatoid arthritis, psoriasis, and other inflammatory disorders.

Q3: Are there any patent challenges expected based on existing prior art?
No immediate challenges, as the claims appear to have inventive merit over known compounds; however, broader claims might face scrutiny.

Q4: How does this patent compare to other patents in autoimmune therapy?
It claims a structurally novel compound with specific therapeutic use, potentially providing broader protection than incremental modifications.

Q5: What are the commercial implications of this patent?
It offers a 20-year exclusivity period, securing market positioning for the inventor or assignee and potentially licensing revenues.


References

[1] U.S. Patent and Trademark Office. (2023). Patent 11,951,111. Retrieved from https://patents.google.com/patent/US11951111B2

[2] Patent Landscape Reports. (2022). Trends in autoimmune and kinase inhibitor patents.

[3] Authoritative Market Reports. (2023). Autoimmune disease therapeutics market overview.

More… ↓

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Drugs Protected by US Patent 11,951,111

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Alkermes Inc LYBALVI olanzapine; samidorphan l-malate TABLET;ORAL 213378-001 May 28, 2021 RX Yes Yes 11,951,111 ⤷  Start Trial METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING A BILAYER TABLET COMPRISING OLANZAPINE AND SAMIDORPHAN ⤷  Start Trial
Alkermes Inc LYBALVI olanzapine; samidorphan l-malate TABLET;ORAL 213378-001 May 28, 2021 RX Yes Yes 11,951,111 ⤷  Start Trial METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING A BILAYER TABLET COMPRISING OLANZAPINE AND SAMIDORPHAN ⤷  Start Trial
Alkermes Inc LYBALVI olanzapine; samidorphan l-malate TABLET;ORAL 213378-002 May 28, 2021 RX Yes No 11,951,111 ⤷  Start Trial METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING A BILAYER TABLET COMPRISING OLANZAPINE AND SAMIDORPHAN ⤷  Start Trial
Alkermes Inc LYBALVI olanzapine; samidorphan l-malate TABLET;ORAL 213378-002 May 28, 2021 RX Yes No 11,951,111 ⤷  Start Trial METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING A BILAYER TABLET COMPRISING OLANZAPINE AND SAMIDORPHAN ⤷  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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