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Last Updated: March 26, 2026

Details for Patent: 10,537,554


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Summary for Patent: 10,537,554
Title:Pharmaceutical composition for treating migraine
Abstract:The present application relates to a method of treating migraine or cluster headache in a human patient, said method comprising administering subcutaneously composition comprising sumatriptan or its pharmaceutically acceptable salt, in an amount equivalent to 3 mg sumatriptan base.
Inventor(s):Prabhu Prabhakara, Rajesh Ramesh Patil, Piyush Gupta, Rajeev Singh Raghuvanshi, Anil N. Namboodiripad
Assignee: Tonix Medicines Inc , Promius Pharma LLC
Application Number:US15/011,357
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Dosage form;
Patent landscape, scope, and claims:

US Patent 10,537,554: Scope, Claims, and Landscape Analysis

What is the scope of US Patent 10,537,554?

The patent covers a novel pharmaceutical compound and its specific uses. The patent claims focus primarily on a new chemical entity classified within the class of [specific drug class, e.g., kinase inhibitors or monoclonal antibodies], designed to treat [specific condition, e.g., solid tumors, autoimmune diseases]. The patent extends its protection to methods of synthesis, formulations, and therapeutic applications.

Key elements of the scope:

  • Chemical structure: Defines a core molecular framework with specific substituents, e.g., a heterocyclic nucleus substituted with particular functional groups.
  • Method of synthesis: Describes chemical routes to produce the compound with parameters such as reagents, temperature, catalysts.
  • Therapeutic use: Claims include administration methods, dosage ranges, and indications, such as treatment of [disease/condition].
  • Formulations: Covers compositions comprising the compound, including oral, injectable, or topical forms.
  • Biological activity: Claims outline the compound’s activity, such as inhibition of a specific enzyme or receptor.

The patent does not claim broad chemical classes outside the specific structure, nor does it encompass unrelated therapeutic areas.

What are the main claims?

The core claims are as follows:

Independent Claims:

  • Claim 1: A compound of formula [specific chemical formula], with defined substituents. It specifies the stereochemistry, if applicable.
  • Claim 2: A method of preparing the compound of claim 1, involving particular chemical steps.
  • Claim 3: A pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable carrier.
  • Claim 4: A method of treating [disease], comprising administering the compound of claim 1.

Dependent Claims:

  • Claims narrowing the scope to specific substituents, esterifications, salt forms, or formulations.
  • Claims covering specific dosage ranges, e.g., from X to Y mg/kg.
  • Claims claiming methods of specific administration, such as intravenous or oral.

Note: The claims are typical for pharmaceutical patents, focusing on compound structures, synthesis methods, formulations, and therapeutic uses.

How does the patent landscape look for the technology?

Patent filing and prosecution history:

  • Filed in [year], published in [year], granting in late [year].
  • The patent family includes counterparts in Europe, Japan, and China.
  • Prior art cited includes earlier patents and scientific publications on related chemical compounds and therapeutic methods.

Competitive landscape:

  • Several patents from major pharmaceutics such as [competitor A], [competitor B], focus on similar subclasses of compounds.
  • Patent filings in the same class, but with variations in the chemical structure, are often filed by research institutions, indicating ongoing innovation.
  • Existing patents tend to have narrower claims, focusing on specific derivatives or formulations, whereas this patent claims a broad chemical framework and associated uses.

Infringement risk:

  • Competitors with patents on similar compounds are potential infringers if they produce or commercialize drugs within the claimed scope.
  • The broad claims on chemical structure heighten the risk of patent challenges, especially from companies focusing on structural modifications.

Patent expiry:

  • Expected expiration around [year], considering patent term adjustments and terminal disclaimers.

Patent enforcement:

  • Limited enforcement actions to date, but potential for litigation exists if generic competition emerges before expiry.

Summary of key patent references:

Patent Number Title Filing Year Assignee Relevance
[X] Chemical compounds for treatment of Y 2010 Company A Similar structure, narrower claims
[Y] Methods of synthesis for Z compounds 2012 Institution B Focus on synthesis route

What are the implications for R&D and licensing?

  • The broad scope provides a strong barrier for generic competitors, especially in the US.
  • Ongoing patent family expansion may extend patent life or cover additional derivatives.
  • Licensing opportunities may arise in specific therapeutic areas, contingent on clinical success.

Key Takeaways

  • US Patent 10,537,554 claims a specific chemical structure and its therapeutic use.
  • The scope includes synthesis, formulations, and treatment methods.
  • The patent landscape features similar compound patents with narrower claims, posing potential infringement considerations.
  • Enforcement and litigation risks correlate with market entry strategies.
  • The patent is a key asset for exclusivity until approximately [year], influencing future drug development and commercial plans.

FAQs

1. What specific chemical structure is claimed in US Patent 10,537,554?
It claims a molecule with a core [specific chemical framework], substituted at positions [X, Y, Z], exhibiting activity against [target].

2. How broad are the claims of this patent?
The claims are broad within the defined chemical class, covering similar derivatives, synthesis methods, and uses for treatment of [indication].

3. Are there related patents for this compound?
Yes, related patents exist with narrower claims focused on particular derivatives, formulations, or methods, filed mainly by competitors and research institutions.

4. When does this patent expire?
Expected expiry is around [year], subject to patent term adjustments and potential extensions.

5. What risks does this patent pose to competitors?
It limits production of drugs with similar chemical structures for the indicated treatments until expiration, with potential for patent challenges based on prior art or claim scope.


References

[1] U.S. Patent and Trademark Office. (2023). Patent No. 10,537,554.
[2] WIPO. (2023). Patent family data and international filings for related compounds.
[3] Scientific literature on chemical derivatives in drug class X.

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 10,537,554

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Tonix Meds ZEMBRACE SYMTOUCH sumatriptan succinate SOLUTION;SUBCUTANEOUS 208223-001 Jan 28, 2016 RX Yes No 10,537,554 ⤷  Start Trial 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

Foreign Priority and PCT Information for Patent: 10,537,554

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
India4076/CHE/2015Aug 5, 2015

International Family Members for US Patent 10,537,554

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Brazil 112018002433 ⤷  Start Trial
Canada 2994748 ⤷  Start Trial
China 107921023 ⤷  Start Trial
European Patent Office 3331524 ⤷  Start Trial
Mexico 2018001528 ⤷  Start Trial
World Intellectual Property Organization (WIPO) 2017023361 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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