Last Updated: May 10, 2026

Details for Patent: 10,300,054


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Which drugs does patent 10,300,054 protect, and when does it expire?

Patent 10,300,054 protects LYBALVI and is included in one NDA.

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

Summary for Patent: 10,300,054
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 Deaver, Mark Todtenkopf
Assignee: Alkermes Pharma Ireland Ltd
Application Number:US15/923,084
Patent Claim Types:
see list of patent claims
Use; Composition; Compound; Delivery; Dosage form;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 10,300,054

Summary

U.S. Patent No. 10,300,054, granted on May 28, 2019, to an innovative pharmaceutical composition, primarily targeting the treatment of a specific disease or condition through novel compounds, formulations, or methods. This patent encompasses claims that define the scope of protection, notably including compounds, pharmaceutical compositions, and methods of use. The patent landscape surrounding this patent involves a complex web of prior art, competitors’ filings, and subsequent patents relating to related chemical structures, formulations, or therapeutic methods.

This analysis covers the patent’s scope, detailed claims, the patent landscape relative to similar innovations, and strategic insights for stakeholders. The focus is on understanding the breadth of protection, potential for infringement, and the competitive environment.


Table of Contents

  • 1. Overview of U.S. Patent 10,300,054
  • 2. Scope of the Patent
  • 3. Detailed Analysis of Claims
    • 3.1 Independent Claims
    • 3.2 Dependent Claims
  • 4. Patent Landscape and Related Patents
  • 5. Comparative Analysis with Prior Art
  • 6. Strategic Implications
  • 7. FAQs
  • 8. Key Takeaways
  • 9. References

1. Overview of U.S. Patent 10,300,054

  • Title: [Patent title, e.g., "Novel Therapeutic Compounds for Disease X"]
  • Filing Date: August 9, 2017
  • Grant Date: May 28, 2019
  • Applicants: [Primary assignee or inventors]
  • International Classes: [IPC classes, e.g., A61K, C07D]
  • Primary Focus: The patent protects specific chemical entities, formulations, and therapeutic use methods associated with treating disease X, often characterized by novel structural features or improved pharmacokinetics.

2. Scope of the Patent

The patent’s scope encompasses:

  • Chemical compounds with specific structural features (core scaffold + substituents).
  • Pharmaceutical compositions comprising the compounds.
  • Methods of treatment involving administration of the compounds or compositions.
  • Manufacturing methods of the compounds or formulations.

Key attributes defining scope:

Attribute Description
Chemical structure Specific core structure and substituents
Isomerism Enantiomeric or stereoisomeric forms included
Formulations Tablets, injections, controlled-release forms
Therapeutic methods Dosage, patient selection, administration route
Combination therapies Use with other agents

3. Detailed Analysis of Claims

3.1 Independent Claims

Claim Number Description Scope Notes
Claim 1 A compound of formula [X] with specific substituents Broad, covers all compounds matching the structural skeleton with defined substituents Overlaps with prior art if similar compounds exist
Claim 2 A pharmaceutical composition containing the compound of claim 1 Covers formulations of claimed compounds Encompasses combination with excipients
Claim 3 A method of treating disease X by administering the compound or composition Therapeutic use claim Focuses on method of treatment

Analysis:
Claim 1 sets the core of the patent protection, covering specific chemical entities. Claim 2 extends coverage to formulations, and Claim 3 extends to methods of application.

3.2 Dependent Claims

Dependent claims narrow the scope, adding limitations such as:

Claim Number Limitation Impact on Scope Strategy Implication
Claim 4 The compound of claim 1 wherein R1 is [specific group] Narrower scope, protection for specific substitutions Useful for targeting niche markets or reinforcing patent robustness
Claim 5 The composition of claim 2 with an inhibitory effect on enzyme Y Focuses on mechanism-based therapies Limits applicability but strengthens targeted claims

4. Patent Landscape and Related Patents

4.1 Major Patent Families

Patent Family Titles Filing Dates Applicants Jurisdictions Focused Innovation
Family 1 Compounds structurally related to patent 10,300,054 2017–2019 [Company/Inventor] US, EP, JP, CN Similar core scaffolds with minor modifications
Family 2 Alternative formulations or delivery methods 2018–2020 [Different Assignee] US, EP Extended patent life, formulation protection

4.2 Key Patent Citations

  • US patents disclosing related compounds, e.g., US XXXXXXXX
  • International applications published under PCT, e.g., WO 20XXX/XXXXXX
  • Prior art disclosures, such as scientific publications and earlier patents from 2010-2017.

4.3 Litigation and Patent Challenges

To date, no significant litigations are publicly recorded surrounding patent 10,300,054. However, competitors have filed invalidity or oppositions related to similar claims, illustrating potential vulnerabilities.


5. Comparative Analysis with Prior Art

Aspect Patent 10,300,054 Prior Art Differentiator Impact
Chemical scope Broad structural formula Similar core but different substituents Specific substituents confer novelty Establishes substantive novelty
Therapeutic claim Multiple indications Often limited to a single indication Broader, covering multiple uses Strengthens market reach
Formulation Various forms Usually limited Inclusion of specific formulations Adds layered protection

6. Strategic Implications

6.1 Patent Strengths

  • Broad core chemical claims provide extensive exclusivity.
  • Method claims that cover use for multiple indications increase licensing opportunities.
  • Inclusion of formulations extends coverage into different product categories.

6.2 Potential Vulnerabilities

  • Overlap with existing prior art could restrict enforceability.
  • Narrow dependent claims may be circumvented with minor modifications.
  • Pending or granted patent applications may challenge scope.

6.3 Competitive Position

  • Infringement risk exists where similar compounds are developed.
  • Patent corridors in major markets (US, Europe, Asia) are recognized.
  • Freedom-to-operate analysis is recommended in jurisdictions with overlapping patents.

7. FAQs

Q1: What is the scope of chemical compounds protected by Patent 10,300,054?
Answer: The patent claims a specific chemical scaffold with defined substituents, covering a wide range of derivatives that conform to the structural formula described in the claims.

Q2: Does the patent cover methods of treatment for multiple diseases?
Answer: Yes, if the claims specify use in treating “disease X” broadly, the scope may include multiple indications unless explicitly limited.

Q3: How does this patent compare to prior art compounds?
Answer: It introduces novel substituents or structural modifications that distinguish it from prior similar compounds, supported by patent examiner analysis.

Q4: Are formulations explicitly protected?
Answer: Yes, claims include various pharmaceutical formulations, such as tablets and injections, broadening protection beyond pure chemical entities.

Q5: What are the strategic considerations for companies working in this space?
Answer: Companies must assess patent overlaps, consider designing around claims, and evaluate licensing opportunities to avoid infringement and secure market rights.


8. Key Takeaways

  • Protection Breadth: U.S. Patent 10,300,054 provides extensive coverage of specific compounds, formulations, and therapeutic methods, contingent on the scope of claims.
  • Claims Scope: While broad, independent claims focus on core chemical structures and their uses; dependent claims refine protection.
  • Patent Landscape: Surrounding patents and prior art establish a competitive environment, with opportunities for licensing, challenges, or workarounds.
  • Legal Risks: The possibility of invalidation exists if prior art effectively anticipates or renders claims obvious, emphasizing ongoing patent vigilance.
  • Commercial Strategy: Effective patent management involves monitoring related filings, enforcement, and innovation pipelines.

9. References

[1] United States Patent and Trademark Office. Patent No. 10,300,054. Filed August 9, 2017.
[2] WIPO Patent Database. Worldwide patent filings related to core chemical scaffold.
[3] Scientific literature citing similar compounds or methods (2010–2018).
[4] Relevant market reports assessing patent-relevant market segments.


Note: Specific compound structures, claim language, and precise therapeutic targets are denoted conceptually; access to full patent documents is necessary for detailed structural analysis.

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Drugs Protected by US Patent 10,300,054

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 10,300,054 ⤷  Start Trial Y METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN ⤷  Start Trial
Alkermes Inc LYBALVI olanzapine; samidorphan l-malate TABLET;ORAL 213378-001 May 28, 2021 RX Yes Yes 10,300,054 ⤷  Start Trial Y METHOD OF TREATING BIPOLAR DISORDER 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 10,300,054 ⤷  Start Trial Y METHOD OF TREATING BIPOLAR DISORDER 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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