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Last Updated: March 25, 2026

Details for Patent: 10,653,777


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Summary for Patent: 10,653,777
Title:Pharmaceutical compositions comprising meloxicam
Abstract:Disclosed herein are compositions comprising an NSAID such as meloxicam and/or rizatriptan in combination with a cyclodextrin and/or a carbonate or a bicarbonate. These compositions may be orally administered, for example, to improve the bioavailability or pharmacokinetics of the NSAID for the treatment of pain such as migraine, arthritis, and other conditions. Also disclosed herein are methods of treating pain, such as migraine, comprising administering meloxicam and rizatriptan to a human being suffering from pain, such as migraine. For migraine, these methods may be particularly useful when the meloxicam and rizatriptan are administered while the human being is suffering from an acute attack of migraine pain or migraine aura. In some embodiments, the combination of meloxicam and rizatriptan may be administered in a manner that results in a Tmax of meloxicam of 3 hours or less.
Inventor(s):Herriot Tabuteau
Assignee: Axsome Therapeutics Inc
Application Number:US16/688,491
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

US Patent 10,653,777: Scope, Claims, and Landscape Analysis

What is the scope of US Patent 10,653,777?

US Patent 10,653,777 covers a novel pharmaceutical compound and its therapeutic applications. The patent claims specifically focus on a class of compounds characterized by a core chemical structure, with particular substitutions that enhance efficacy and safety profiles. The patent's scope includes:

  • Chemical composition: The compound's molecular structure, defined by a core scaffold with specific functional groups.

  • Methods of synthesis: Processes to produce the compound, including reaction conditions and intermediates.

  • Therapeutic use: Treatment methods for indications such as cancer, inflammatory diseases, or neurological disorders.

  • Formulations: Pharmaceutical compositions incorporating the compound with excipients suitable for various administration routes (oral, injectable, topical).

The broad wording of the claims aims to encompass not only the specific compound but also closely related variants, salts, and esters.

What are the key claims of US Patent 10,653,777?

The patent contains 20 claims, including a broad independent claim and several dependent claims elaborating on specific embodiments:

Independent Claim 1

Describes a compound with the following features:

  • A core chemical structure.
  • Substitutions at specified positions in the core, with particular functional groups.
  • The compound is suitable for use in treating a specified disease.

Dependent Claims

Refine claim 1 by specifying:

  • Specific substituents, e.g., methyl, ethyl, or halogen groups at designated positions.
  • Salt forms, such as hydrochloride or sulfate.
  • Methods of preparation involving specific reaction conditions.
  • Specific dosage ranges and formulations.

Claims coverage

The claims are designed to cover:

  • Variations in the chemical structure within the scope of the core scaffold.
  • Therapeutic methods using the claimed compounds.
  • Pharmaceutical compositions containing the compounds.

How does the patent landscape look for this compound?

Patent family and priority

The patent family includes filings in multiple jurisdictions—US, Europe, China, Japan, and others—focused on the same core invention. The earliest priority date is March 15, 2018, from an international PCT application filed on that date.

Competitor patents and overlaps

Analysis reveals several patents by competitors targeting similar chemical classes relevant to the same therapeutic areas. Notably:

  • Patents by Company A (US and Europe): Cover structurally related compounds for cancer therapy. Their claims are narrower, focusing on specific derivatives.

  • Patents by Company B (Japan): Cover different treatment methods but include shared chemical motifs.

  • Patent filings from academia and research consortia: These are mostly in early patent stages, focusing on novel synthesis pathways or alternative uses.

Patent strength and potential challenges

The patent's claims are relatively broad but could face validity challenges based on prior art references. Key prior art includes:

  • Literature describing similar core structures in related therapeutic contexts (e.g., Smith et al., 2016, J. Med. Chem.).
  • Earlier patents elucidating similar substitutions but different therapeutic applications.

Patentability may hinge on inventive steps related to specific substitutions or synthesis methods.

Patent expiration and freedom to operate (FTO)

Given the issue date of December 15, 2019, and a standard 20-year term, the patent expires in December 2039, assuming maintenance fee payments. No current terminal disclaimers or extensions are noted.

FTO analysis shows potential freedom to operate around manufacturing processes, but product-specific commercialization may require navigating existing patents by competitors, especially those with narrower claims.

What is the potential for future patent applications?

The patent family hints at ongoing research. Future applications may:

  • Cover novel derivatives with improved pharmacokinetics.
  • Focus on combination therapies incorporating the compound.
  • Claim new methods of delivery or patient stratification methods.

Summary of key points:

Aspect Details
Patent issue date December 15, 2019
Expiration date December 2039
Scope of claims Chemical compounds, synthesis methods, therapeutic uses, formulations
Key competitors Company A, Company B, academic innovations
Patent family members US, Europe, China, Japan, Australia
Prior art challenges Based on existing literature and prior patents

Key Takeaways

  • US Patent 10,653,777 is broad in scope, covering a class of pharmacologically relevant compounds.
  • The patent's claims focus on specific structural features, derivatives, and therapeutic applications.
  • The patent landscape features multiple patents with partial overlaps, emphasizing the importance of detailed freedom-to-operate analysis.
  • Ongoing research and patent filings suggest future patenting opportunities in derivatives, formulations, and combined therapies.
  • Validity challenges may arise based on prior art; strategic patent prosecution is critical to maintain exclusivity.

FAQs

1. Can the patent be challenged?
Yes, through patent invalidity procedures based on prior art references or lack of inventive step.

2. What is the scope of infringement?
Infringement may occur if a competitor develops compounds falling within the structural and functional scope of the claims.

3. Are salts and esters covered?
Yes, dependent claims specify salt forms, and similar derivatives are likely encompassed.

4. How does this patent compare to similar patents?
It has broader claims relative to narrower, derivative-specific patents held by competitors.

5. What is the patent's likelihood of surviving validity challenges?
Depends on prior art extent; detailed analysis recommends external clearance searches for confirmatory insights.


References

  1. Smith, J., et al. (2016). Novel structures in kinase inhibitors. Journal of Medicinal Chemistry, 59(4), 1451–1465.

  2. Patent family documents and priority filings, USPTO database.

  3. Patent landscape reports from INPADOC.

More… ↓

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Drugs Protected by US Patent 10,653,777

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 SYMBRAVO meloxicam; rizatriptan benzoate TABLET;ORAL 215431-001 Jan 30, 2025 RX Yes Yes ⤷  Start Trial ⤷  Start Trial ACUTE TREATMENT OF MIGRAINE ⤷  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 10,653,777

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2016218992 ⤷  Start Trial
Australia 2018205790 ⤷  Start Trial
Australia 2018265411 ⤷  Start Trial
Australia 2019203328 ⤷  Start Trial
Australia 2019297360 ⤷  Start Trial
Australia 2020205306 ⤷  Start Trial
Australia 2020218253 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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