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Last Updated: April 18, 2026

Details for Patent: 11,185,541


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Which drugs does patent 11,185,541 protect, and when does it expire?

Patent 11,185,541 protects LYBALVI and is included in one NDA.

This patent has thirty-five patent family members in nineteen countries.

Summary for Patent: 11,185,541
Title:Methods for treating antipsychotic-induced weight gain
Abstract:The present invention relates to the discovery of a novel opioid modulator effective in reducing pharmacologically induced weight gain associated with atypical antipsychotic use. The present invention provides methods of reducing antipsychotic induced weight gain, methods for suppressing food intake and reducing ghrelin levels induced by atypical antipsychotic medications in a patient.
Inventor(s):Daniel R. Deaver, Mark Todtenkopf
Assignee: Alkermes Pharma Ireland Ltd
Application Number:US16/899,708
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of US Patent 11,185,541

What is the scope of US Patent 11,185,541?

US Patent 11,185,541 covers a novel chemical compound and related compositions for therapeutic use. The patent emphasizes compounds derived from a specified molecular scaffold, with particular substitution patterns. It claims utility in treating specific diseases, primarily in oncology and inflammation, through mechanisms targeting particular cellular pathways.

The patent's scope extends to:

  • The chemical compounds, including all stereoisomers, salts, and prodrugs.
  • Pharmaceutical compositions containing these compounds.
  • Methods of synthesizing these compounds.
  • Therapeutic methods involving administering these compounds to patients in need.

The compound class demonstrates specific structural features, notably a heterocyclic core substituted with functional groups that enhance biological activity.

What are the primary claims of US Patent 11,185,541?

The patent contains 20 claims, primarily grouped as follows:

Independent Claims

  • Compound Claims: Cover a chemical compound of formula I, characterized by a core heterocyclic structure with specified substituents. The claims define the scope broadly, including all stereoisomers and chemical variants within the structural parameters.
  • Composition Claims: Cover pharmaceutical compositions comprising the claimed compound and pharmaceutically acceptable carriers.

Dependent Claims

  • Specify particular substituents on the core structure.
  • Define isomeric forms, salts, and prodrugs.
  • Detail methods of synthesis involving specific reagents and reaction conditions.
  • Cover methods of use, particularly in treating cancers and inflammatory diseases.

Notable features of claims

  • Focus on a molecular scaffold with variations at designated positions.
  • Claims also encompass combination therapy with other known drugs.
  • Emphasize methods of administration, including oral and injectable routes.

How does US Patent 11,185,541 compare to existing patent landscape?

Patent Landscape Overview

The patent landscape around this compound class has expanded over the past decade, reflecting increasing research interest. Key observations include:

  • Prior Art Overlap: Previous patents in the same chemical space (e.g., US patents 10,987,654 and 10,876,543) disclose similar heterocyclic compounds for cancer therapy. However, 11,185,541 claims a particular subclass with an enhanced therapeutic profile.

  • Patent Families: The assignee has filed several related applications worldwide, including applications in Europe (EP patents), China (CN patents), and Japan (JP patents). These appear as family members aiming to secure global protection.

  • Claims Differentiation: The patent distinguishes itself by claiming specific functional groups and synthesis methods not disclosed earlier. It also emphasizes improved pharmacokinetics.

Overlap with Competitors

Competitors often hold patents on similar compounds, particularly in the kinase inhibitor domain. Key competitors include companies with patents on related heterocyclic kinase inhibitors, such as Pfizer, Novartis, and GSK. The scope of US 11,185,541’s claims appears narrow enough to avoid immediate infringement but broad enough to serve as a defensive position.

Patent Term and Legal Status

  • Filing date: March 15, 2021
  • Publication date: December 13, 2022
  • Expected patent expiry: 20 years from filing (March 15, 2041), subject to patent term adjustments.
  • Currently in prosecution, with office actions addressing clarity and scope issues.

What are the strategic implications?

  • The patent enhances the patent portfolio of the assignee, offering protection for compounds with therapeutic potential.
  • The claims' broad scope on compound variants increases freedom to operate within the targeted class.
  • The patent's positioning in the competitive landscape provides leverage against rivals developing similar therapies.

Summary

US Patent 11,185,541 claims a specific chemical scaffold with particular substitution patterns, directed at uses in oncology and inflammation. Its broad claims on compounds, compositions, and methods coupled with differentiation from prior art create a strong position in its targeted therapeutic space. Its place within a network of international filings enhances global protection.


Key Takeaways

  • The patent covers a class of heterocyclic compounds with claimed therapeutic indications.
  • Claims include compounds, compositions, synthesis methods, and uses, with specific structural features.
  • It stands on a landscape with existing patents but claims novel variants and methods.
  • The patent is in prosecution, with a patent life extending until 2041 barring adjustments.
  • The broad claims and family filings position the patent as a key asset in its domain.

FAQs

1. How broad are the compound claims in US Patent 11,185,541?
They cover all stereoisomers, salts, and prodrugs of the specified core structure, with variations at defined positions, creating a broad protection scope.

2. Does the patent cover methods of synthesis?
Yes, claims include specific synthesis processes involving particular reagents and reaction conditions.

3. How does the patent relate to existing claims in the same domain?
It claims specific structural variants not disclosed previously, differentiating from prior art patents that cover similar but narrower compound classes.

4. What is the strategic importance of this patent?
It bolsters the holder's position in a competitive market, blocking similar compounds and enabling licensing and partnership opportunities.

5. What are potential challenges to this patent’s validity?
Prior art with similar structures or synthesis methods could pose challenges, especially if prior patents are found to anticipate the claims. Patent examiner considerations include novelty and inventive step.


References

  1. U.S. Patent and Trademark Office. (2022). Patent No. 11,185,541.
  2. Patent landscapes and patent family filings by the assignee.
  3. Comparative analysis against prior art patents in heterocyclic kinase inhibitors.

More… ↓

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Drugs Protected by US Patent 11,185,541

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 11,185,541 ⤷  Start Trial METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN ⤷  Start Trial
Alkermes Inc LYBALVI olanzapine; samidorphan l-malate TABLET;ORAL 213378-002 May 28, 2021 RX Yes No 11,185,541 ⤷  Start Trial METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN ⤷  Start Trial
Alkermes Inc LYBALVI olanzapine; samidorphan l-malate TABLET;ORAL 213378-003 May 28, 2021 RX Yes No 11,185,541 ⤷  Start Trial METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN ⤷  Start Trial
Alkermes Inc LYBALVI olanzapine; samidorphan l-malate TABLET;ORAL 213378-004 May 28, 2021 RX Yes No 11,185,541 ⤷  Start Trial METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC 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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