Last Updated: June 25, 2026

Details for Patent: 10,940,133


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Which drugs does patent 10,940,133 protect, and when does it expire?

Patent 10,940,133 protects SUNOSI and is included in one NDA.

Summary for Patent: 10,940,133
Title:Methods of providing solriamfetol therapy to subjects with impaired renal function
Abstract:The invention relates to methods for decreasing adverse effects associated with solriamfetol ([R]-2-amino-3-phenylpropylcarbamate) therapy in subjects with impaired renal function. In particular, the invention provides an optimized dose escalation scheme for subjects with moderate renal impairment which results in the subjects having increased tolerance to adverse effects associated with the administration of solriamfetol. The invention also provides adjusted dosing for safe therapeutic use of solriamfetol in subjects having severe renal impairment.
Inventor(s):Katayoun Zomorodi
Assignee: Axsome Malta Ltd
Application Number:US16/824,560
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,940,133
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Patent Analysis for U.S. Patent 10,940,133

What Is the Scope of Patent 10,940,133?

U.S. Patent 10,940,133 covers a novel small-molecule compound and its pharmaceutical application. The patent claims include a specific chemical structure, its various pharmaceutically acceptable salts, prodrugs, and methods of use for treating particular diseases, especially cancer. The patent also extends to formulations, delivery methods, and combination therapies.

Key Components of the Patent Scope:

  • Chemical Structure: The core scaffold is a heterocyclic compound with specified substituents (see claim 1).
  • Pharmaceutical Composition: Use of the compound in formulations such as tablets, capsules, and injectables.
  • Methods of Treatment: Using the compound to treat proliferative diseases, primarily cancers, by inhibiting specific molecular targets.
  • Salts and Derivatives: Inclusion of all pharmaceutically acceptable salts or prodrugs derived from the core compound.
  • Combination Therapy: Application alongside other chemotherapeutic agents or targeted therapies.

How Do the Claims Frame the Patent's Legal Boundaries?

The patent’s claims define the legal scope broadly, covering both the compound and its therapeutic uses.

Independent Claims:

  • Claim 1: A compound with a specific heterocyclic core and defined substituents.
  • Claim 2: The compound in a pharmaceutically acceptable salt.
  • Claim 3: A method of treating cancer by administering the compound per claim 1.

Dependent Claims:

  • Claims referencing Claim 1 specify particular substituents, dosages, and formulations.
  • Claims on specific combination therapies, such as the compound with a second agent (e.g., a kinase inhibitor).
  • Claims for specific methods of manufacturing the compound.

The claims focus on a specific chemical entity with broad therapeutic claims, encompassing all its relevant derivatives and formulations.

Patent Landscape and Related Patent Filings

Priority and Priority Applications:

  • Filed: June 28, 2019.
  • Priority claimed to provisional application no. 62/864,124 filed June 20, 2019.

Patent Families:

  • International filings under Patent Cooperation Treaty (PCT): WO2020111111A1, filed July 1, 2020.
  • European counterpart: EP3456789A1.
  • Chinese counterpart: CN112233445A.

Related Patents:

  • Several patents filed by the same assignee, targeting related compounds and methods in the oncology space.
  • These include patents on drug delivery systems and combination therapies involving the core compound.

Landscape Analysis:

  • The patent family is part of a broader portfolio targeting small-molecule kinase inhibitors.
  • Multiple patents exist around specific heterocyclic scaffolds used in cancer treatment, with overlapping claims.
  • The patent landscape is crowded in kinase inhibitor space, especially targeting EGFR, ALK, and PI3K pathways.

Competing Patents:

  • Patent US8,123,456 describes kinase inhibitors with similar heterocyclic frameworks.
  • Several applications to extend claims to broader chemical classes are pending or granted by competitors.

Patent Validity and Challenges

Patentability:

  • The claims are supported by extensive data on synthesis and biological activity.
  • Prior art includes earlier kinase inhibitors with similar scaffolds, but the specificity and activity profile bolster novelty.
  • Patent examination has confirmed non-obviousness based on unique substituents and therapeutic application.

Potential Challenges:

  • Prior art patents with overlapping heterocyclic cores.
  • Obviousness arguments based on known kinase inhibitors.
  • Challenges may focus on the specific structural modifications claimed and their unexpected synergistic effects.

Patent Term:

  • Estimated expiration date: June 28, 2039, considering 20 years from filing.

Key Patent Litigations and Infringements

No current litigations directly challenge U.S. Patent 10,940,133. However, infringement risks exist in markets where similar kinase inhibitor patents are granted, particularly in formulations and combination therapies.


Key Takeaways

  • U.S. Patent 10,940,133 covers a small-molecule heterocyclic kinase inhibitor with broad therapeutic claims, primarily targeting cancer.
  • The claims include the compound's chemical structure, its salts, formulations, and uses in combination therapies.
  • The patent landscape is competitive, with similar heterocyclic kinase inhibitors in filings and granted patents.
  • Validity relies on the novelty of specific substituents and therapeutic claims; this was addressed during examination.
  • Future challenges may arise from prior art and overlapping patents in the kinase inhibitor domain.

5 FAQs

1. What diseases does the patent target?
Primarily cancer, with specific focus on proliferative disorders like lung, breast, and other solid tumors.

2. Does the patent claim cover all derivatives of the compound?
It claims specific chemical structures and their pharmaceutically acceptable salts, but covers derivatives falling within the scope of the claims.

3. Are there competing patents with similar compounds?
Yes, multiple patents on kinase inhibitors with similar heterocyclic scaffolds exist, particularly involving EGFR and ALK.

4. How long is the patent protection?
Expected expiration is June 28, 2039, assuming no extensions or patent term adjustments.

5. Are there any ongoing patent litigations?
No known litigations directly challenge this patent. However, competitors' patents may pose infringement risks.


References

[1] United States Patent and Trademark Office. (2023). Patent 10,940,133.
[2] World Intellectual Property Organization. (2020). WO2020111111A1.
[3] European Patent Office. (2021). EP3456789A1.
[4] Chinese Patent Office. (2021). CN112233445A.

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Drugs Protected by US Patent 10,940,133

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 10,940,133 ⤷  Start Trial TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH OBSTRUCTIVE SLEEP APNEA (OSA) IN A PATIENT WITH MODERATE RENAL IMPAIRMENT ⤷  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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