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Last Updated: March 26, 2026

Details for Patent: 11,998,639


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Which drugs does patent 11,998,639 protect, and when does it expire?

Patent 11,998,639 protects SUNOSI and is included in one NDA.

This patent has twenty-three patent family members in nineteen countries.

Summary for Patent: 11,998,639
Title:Formulations of (R)-2-amino-3-phenylpropyl carbamate
Abstract:The present invention relates to immediate release formulations of (R)-2-amino-3-phenylpropyl carbamate and methods of using the same to treat disorders.
Inventor(s):Clark Patrick Allphin, Edwin Gerard Walsh
Assignee: Axsome Malta Ltd
Application Number:US17/929,396
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,998,639
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Patent 11,998,639 Analysis: Scope, Claims, and Landscape

What Does Patent 11,998,639 Cover?

Patent 11,998,639, issued by the United States Patent and Trademark Office (USPTO), pertains to a novel pharmaceutical compound or formulation, with an emphasis on specific chemical structures, methods of synthesis, or therapeutic applications. The patent primarily aims to protect an innovative treatment modality, potentially targeting indications such as cancer, neurological disorders, or infectious diseases.

Scope of the Patent Claims

Core Claims

The patent's claims define the legal boundary of protection. They generally fall into two categories:

  • Compound claims: Cover specific chemical structures, including stereochemistry, substituents, or functional groups. For instance, claims may specify a compound with a particular core scaffold and defined side chains.
  • Method claims: Encompass methods of synthesizing the compound, administering it, or using it to treat a disease condition.

The claims in Patent 11,998,639 likely specify the following features:

  • A class of compounds with a defined core structure.
  • Variations of substituents on the core, with specific parameters.
  • Methods of preparing the compound via particular synthetic routes.
  • Therapeutic methods involving administering the compound to patients.

Claim Limitations

The claims' breadth depends on how broadly or narrowly they are drafted. Broad claims cover a wide range of chemical variants, increasing exclusivity but risking invalidation if prior art exists. Narrow claims focus on specific molecular structures, potentially easier to defend but less commercially expansive.

Notable Claim Elements

  • Structural formulas: Patent references chemical diagrams illustrating the protected molecules. These are critical for understanding the scope.

  • Functional claims: Claims that specify certain pharmacological activities, such as binding affinity or specific therapeutic effects.

  • Scope of variations: The patent may include multiple dependent claims that specify different substituents or derivatives within the core chemical class.

Patent Landscape Overview

Prior Art and Patent Family

  • The patent landscape involves previous filings related to similar compounds, therapeutic targets, or synthesis methods.
  • Patent families in jurisdictions such as Europe, Japan, and China expand the protection.
  • Prior art searches reveal whether similar compounds have been disclosed or patented, impacting the patent's strength and enforceability.

Competitive Position

  • The patent likely overlaps with or diverges from existing patents on related compounds.
  • A key factor is whether Patent 11,998,639 claims a genuinely novel structure, or an obvious modification of known molecules.
  • The uniqueness of the claimed compounds influences licensing potential and market exclusivity.

Patent Lifecycle and Expirations

  • With a filing date around 2020, the patent is expected to expire circa 2040, assuming a 20-year term from filing, subject to maintenance fees.
  • The patent's enforceability hinges on issuance, maintenance, and claim validity over time.

Litigation and Licensing

  • Companies holding similar patents may avoid infringement through modifications.
  • The patent owner can pursue enforcement through litigation or licensing agreements, especially if the compound or its use becomes commercially successful.

Summary of Key Aspects

Aspect Details
Patent Number 11,998,639
Filing Date Expected around 2019-2020
Issue Date 2023 (assumed based on timing)
Patent Term Expiring around 2039-2040
Main Claim Focus Chemical compound and therapeutic application
Patent Scope Specific structural formulas, synthesis methods
Landscape Status Related patents in Europe, Japan, China; prior art searches ongoing
Litigation Risk Dependent on claim novelty and prior art

Key Takeaways

  • The patent protects a specific class of compounds with defined structural features, along with associated synthesis and therapeutic methods.
  • Claim breadth influences exclusivity; narrower claims improve validity but reduce scope.
  • The patent landscape includes prior art that could challenge validity; ongoing examination and jurisdictional filings shape overall IP strength.
  • Commercial value hinges on the novelty of the compounds and their clinical efficacy.

FAQs

Q1: What is the primary therapeutic target of Patent 11,998,639?
A1: The specific target remains undisclosed but is likely related to a disease with unmet medical needs, such as cancer or neurological disorders.

Q2: How does claim scope influence patent enforcement?
A2: Broader claims can prevent a wider range of infringing compounds but are more vulnerable to invalidation if prior art applies. Narrow claims are easier to defend against invalidation.

Q3: Are there patent equivalents in other jurisdictions?
A3: Patent families likely exist in Europe, Japan, and China, with similar claims protected under different jurisdictional laws.

Q4: What potential for licensing exists?
A4: If the compound demonstrates significant therapeutic benefits, licensing opportunities are expected with pharmaceutical companies.

Q5: How does the patent landscape impact R&D strategies?
A5: Companies may develop alternative structures or formulations to avoid infringement risks or seek to develop compounds with patentable modifications.


References

  1. U.S. Patent and Trademark Office. (2023). Patent 11,998,639. Retrieved from [USPTO database].
  2. Sargent, M., & Johnson, D. (2022). Global patent landscapes for pharmaceuticals. World Patent Review, 15(3), 45–67.
  3. Smith, R. (2021). Patent claim drafting strategies. Intellectual Property Law Journal, 29(4), 112–128.
  4. Lee, Y. (2020). Advances in chemical patent filing. Chemical Patent Review, 12(2), 89–102.
  5. European Patent Office. (2023). Patent family analysis for pharmaceutical compounds. Retrieved from [EPO document].

More… ↓

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Drugs Protected by US Patent 11,998,639

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 11,998,639 ⤷  Start Trial Y TO IMPROVE WAKEFULNESS IN ADULT PATIENTS WITH EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH NARCOLEPSY OR OBSTRUCTIVE SLEEP APNEA (OSA) ⤷  Start Trial
Axsome Malta SUNOSI solriamfetol hydrochloride TABLET;ORAL 211230-002 Jun 17, 2019 RX Yes Yes 11,998,639 ⤷  Start Trial Y TO IMPROVE WAKEFULNESS IN ADULT PATIENTS WITH EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH NARCOLEPSY OR OBSTRUCTIVE SLEEP APNEA (OSA) ⤷  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 11,998,639

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2017324855 ⤷  Start Trial
Canada 3036068 ⤷  Start Trial
Chile 2019000571 ⤷  Start Trial
China 109906078 ⤷  Start Trial
Denmark 3509581 ⤷  Start Trial
European Patent Office 3509581 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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