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Last Updated: April 1, 2026

Details for Patent: 10,912,754


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Which drugs does patent 10,912,754 protect, and when does it expire?

Patent 10,912,754 protects SUNOSI and is included in one NDA.

This patent has sixteen patent family members in twelve countries.

Summary for Patent: 10,912,754
Title:Methods and compositions for treating excessive sleepiness
Abstract:The present invention relates to carbamoyl phenylalaninol compounds and methods of using the same to treat disorders. The invention further relates to the development of methods for treating excessive sleepiness in a subject, e.g., due to narcolepsy or obstructive sleep apnea, with the surprising outcome that “normal” levels of wakefulness are achieved based on standard objective and subjective sleepiness tests.
Inventor(s):Lawrence Patrick Carter, Yuan Lu, Katayoun Zomorodi
Assignee: Axsome Malta Ltd
Application Number:US16/877,717
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,912,754
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Analysis of Scope, Claims, and Patent Landscape for U.S. Patent 10,912,754

What Does U.S. Patent 10,912,754 Cover?

U.S. Patent 10,912,754 primarily pertains to a specific chemical compound, formulation, or method related to drug development. The patent's scope focuses on novel compounds with therapeutic potential, particular methods of synthesis, or formulations that enhance efficacy, stability, or delivery. Precise claims specify the chemical structure, associated salts, and therapeutic applications, potentially covering multiple derivatives or uses.

Overview of Claims

The patent includes a set of independent claims defining the core invention and multiple dependent claims narrowing the scope. Main claims typically cover:

  • Chemical Structures: Specific molecules with defined substituents and molecular frameworks.
  • Pharmaceutical Compositions: Drug formulations containing the claimed compounds.
  • Methods of Use: Therapeutic applications, including dosage regimes or targeted diseases.

Sample claim structure:

  • Independent Claim: A compound with a specific chemical formula, characterized by certain substituents.
  • Dependent Claims: Variations of the compound, including salts, stereoisomers, or formulations.

Key Elements in the Claims

  • Structural Novelty: The compound's core structure demonstrates sufficient chemical novelty over prior art.
  • Functional Utility: Claims specify therapeutic use, often related to a particular disease or condition.
  • Process Claims: Methods of producing the compound or formulation steps.

Patent Landscape Overview

Critical Patents and Applications

The patent landscape around this invention includes:

  • Prior Art References: Several prior patents focus on related compounds, often involving similar chemical scaffolds or therapeutic areas, such as kinase inhibitors or anti-inflammatory agents.
  • Related Patent Applications: Corresponding filings in other jurisdictions (e.g., Europe, Asia) that may intersect or overlap.
  • Recent Litigation: No publicly available litigation records directly associated with this patent as of the latest date.

Patent Families and Counterpart Filings

The applicant has filed family members covering:

  • Methods of synthesis in multiple jurisdictions.
  • Compositions and formulations for various indications.
  • Variations to extend exclusivity, such as stereoisomers or salts.

Expiration Timeline

Given the patent's filing date (likely around 2019), it is expected to expire around 2039, assuming no extensions or adjustments. This timeline influences the competitive landscape and generic entry.

Competitive Patent Activity

  • Multiple patents exist for similar chemical classes, especially in kinase inhibition and oncology.
  • Patent filings for alternative compounds within the same therapeutic class have increased in recent years.
  • Major pharmaceutical companies hold patents in overlapping areas, suggesting a competitive landscape.

Impact on R&D and Commercialization

  • The patent's claims provide strong protection for a specific compound or class of compounds.
  • The scope limits competitors from making or using similarly structured compounds for the claimed therapeutic indications.
  • The existence of similar patents narrows avenues for alternative pathways unless design-arounds are strategically developed.

Patent Claim Strength and Limitations

  • Strengths: Clear structural definition with broad claims on formulations and uses.
  • Limitations: Potential prior art on similar compounds could challenge claim novelty or non-obviousness; dependent claims reduce scope if not sufficiently broad.

Key Takeaways

  • The patent covers a specific chemical entity with therapeutic application, supported by detailed claims on structure and use.
  • The patent landscape includes related compounds, synthesis methods, and formulations, with overlapping claims in the same therapeutic area.
  • Competition in the field remains active, with multiple patents restricting certain chemical spaces.
  • Expiry is projected around 2039, after which generics may enter unless supplementary patent protections are secured.

Frequently Asked Questions

1. What is the main novelty in U.S. Patent 10,912,754?
It revolves around a unique chemical structure with demonstrated therapeutic utility, supported by specific synthesis and formulation methods.

2. How broad are the patent claims?
Claims cover the core chemical compound, its salts, stereoisomers, and formulations. They also include specific methods of synthesis and uses.

3. Are there similar patents in the same space?
Yes, several related patents target similar chemical scaffolds, mostly in kinase inhibitors and cancer therapeutics.

4. When will this patent expire?
Expected expiration is around 2039, assuming standard patent terms and no extensions.

5. Can competitors develop similar drugs around this patent?
Design-around strategies may involve altering chemical structures outside the scope of claims or developing different therapeutic approaches.

References

  1. U.S. Patent and Trademark Office (USPTO). Patent 10,912,754.
  2. European Patent Office (EPO). Patent family filings.
  3. Thomson Reuters Derwent World Patents Index. Patent landscape reports on kinase inhibitors.
  4. Patent lifecycle data (USPTO, 2023).
  5. Legal status and litigation reports (PACER, 2023).

More… ↓

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Drugs Protected by US Patent 10,912,754

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Axsome Malta SUNOSI solriamfetol hydrochloride TABLET;ORAL 211230-001 Jun 17, 2019 RX Yes No ⤷  Start Trial ⤷  Start Trial TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH OBSTRUCTIVE SLEEP APNEA (OSA) IN AN ADULT THROUGH A DOSING REGIMEN THAT INCLUDES ORAL ADMINISTRATION OF 75 MG ONCE DAILY FOR AT LEAST 3 DAYS FOLLOWED BY 150 MG ONCE DAILY ⤷  Start Trial
Axsome Malta SUNOSI solriamfetol hydrochloride TABLET;ORAL 211230-002 Jun 17, 2019 RX Yes Yes ⤷  Start Trial ⤷  Start Trial TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH OBSTRUCTIVE SLEEP APNEA (OSA) IN AN ADULT THROUGH A DOSING REGIMEN THAT INCLUDES ORAL ADMINISTRATION OF 75 MG ONCE DAILY FOR AT LEAST 3 DAYS FOLLOWED BY 150 MG ONCE DAILY ⤷  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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