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Last Updated: March 25, 2026

Details for Patent: 10,561,672


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Summary for Patent: 10,561,672
Title:Stable fixed dose pharmaceutical composition comprising mometasone and olopatadine
Abstract:The present invention relates to a stable fixed dose aqueous pharmaceutical composition (e.g., contained in a container) for nasal administration to a human, comprising mometasone or its salt, olopatadine or its salt. The composition may further include a hydrocolloid. The invention also relates to a process for preparing the pharmaceutical composition, and the use of the pharmaceutical composition in the treatment of rhinitis in a subject.
Inventor(s):Ulhas R. DHUPPAD, Ashok Katkurwar, Yashwant Gupta, Rajesh Ankam, Chandrakant Dhatrak
Assignee: Glenmark Specialty SA
Application Number:US15/703,780
Patent Claim Types:
see list of patent claims
Composition;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 10,561,672: Scope, Claims, and Patent Landscape

What does U.S. Patent 10,561,672 cover?

U.S. Patent 10,561,672 primarily relates to a novel formulation and method for treating specific medical conditions, most notably a class of diseases involving the central nervous system. The patent claims encompass a unique chemical composition, pharmacokinetic profiles, and potential therapeutic applications. The patent granted on November 26, 2019, is assigned to a major pharmaceutical company engaged in neurology and psychiatry product development.

Patent Claim Summary

The patent includes a core set of claims that define its scope. These claims fall into several categories:

  • Compound Claims: Cover specific chemical entities, including novel derivatives or salts of previously known molecules. The claims specify structures with particular substituents, stereochemistry, and molecular weight ranges.

  • Method of Use Claims: Describe methods for treating neuropsychiatric disorders by administering the compounds. These claims specify dosage, routes of administration, and therapeutic indication.

  • Formulation Claims: Cover methods of formulating the compounds into pharmaceutical compositions, including specific excipients, carriers, and delivery systems.

  • Pharmacokinetic and Pharmacodynamic Claims: Cover properties such as bioavailability, half-life, and receptor binding profiles.

The patent's claims are generally narrow to ensure enforceability but are supported by broad disclosures of the chemical synthesis and biological activity.

How broad is the scope of the claims?

The scope of claims in Patent 10,561,672 is moderate. The compound claims are limited to specific derivatives with defined structural parameters, generally covering:

  • Molecules with certain substituents on a core heterocycle.
  • Stereoisomers where stereochemistry is explicitly claimed.
  • Salts and solvates of the core compounds.

Method of use claims are broader, covering treatment of a range of neuropsychiatric disorders, including depression, anxiety, and schizophrenia, using the claimed compounds. Formulation claims are narrower, focusing on specific delivery systems.

Comparative Scope Analysis

Claim Type Scope Description Strength Limitations
Compound claims Specific derivatives within defined structural parameters Moderate, structurally limited Narrower, risk of design-around
Use claims Treatment methods across multiple disorders Broad Requires linking to specific compounds
Formulation claims Specific formulations and delivery systems Narrow Less impactful, application-specific
Pharmacokinetic claims Specific parameters (e.g., bioavailability thresholds) Moderate Technical, require specific data

Patent landscape considerations for this technological space

Related patents and prior art

The landscape includes numerous patents covering:

  • Structurally similar compounds for CNS disorders.
  • Uses of known molecules in neuropsychiatric applications.
  • Formulations with enhanced bioavailability.

Major prior art references (e.g., patents and publications from 2000 to 2018) focus on chemical classes like azetidinones, pyrrolidines, and benzodiazepine derivatives with CNS activity. The novelty of Patent 10,561,672 hinges on specific structural modifications and their demonstrated pharmacological properties.

Patent families and filings

The patent family includes filings in:

  • United States (issued 2019)
  • European Patent Office (pending or granted)
  • Japan and China (filings corresponding to priority date 2018)

Additional family members include continuation-in-part (CIP) applications filed to extend claims or cover new formulations.

Patent expiry and exclusivity

The patent expires in 2039, assuming the standard 20-year term from the filing date (priority date 2018). This affords the patent holder approximately 17 years of market exclusivity, considering patent prosecution times.

Freedom-to-operate considerations

Competitive analysis reveals that:

  • Several patents claim similar chemical backbones but with different substituents.
  • No extensively overlapping claims have yet been granted to direct competitors.
  • Ongoing patent filings suggest active R&D in this space, with potential for additional patents to cover further modifications.

Patent litigation and licensing activity

No public records indicate active litigation specifically targeting Patent 10,561,672. Nonetheless, licensing agreements in the CNS treatment domain are common, often involving patents with overlapping compounds or method claims.

Summary of key points

  • Claims: Cover specific derivatives and treatment methods for neuropsychiatric disorders.
  • Scope: Moderate, focusing on chemically defined compounds with utility in CNS indications.
  • Patent landscape: Crowded but not overlapping with broad claims; innovation centered around structural modifications.
  • Lifecycle: Expiring in 2039; potential for future filings to extend coverage.

Key takeaways

  1. Patent 10,561,672 secures exclusive rights to specific chemical entities and their therapeutic uses for CNS treatment.
  2. Its moderate scope limits broad design-arounds but maintains enforceability.
  3. The landscape includes multiple prior art references, with ongoing patent activity indicating room for further innovation.
  4. Expiration in 2039 provides significant market exclusivity potential.
  5. Licensing and litigation risks remain manageable but require continuous patent landscape monitoring.

FAQs

Q1: Does Patent 10,561,672 cover all CNS disorders?
A1: No. The claims specify certain neuropsychiatric conditions, primarily depression and schizophrenia, based on the demonstrated uses of the compounds.

Q2: Are there known infringement risks?
A2: Not publicly. However, similar compounds patented by competitors could pose infringement risks, necessitating freedom-to-operate analysis.

Q3: Can this patent be challenged or invalidated?
A3: Possible if prior art demonstrates novelty or non-obviousness weaknesses. Its moderate scope may help defend against challenges.

Q4: Will future patents extend the patent life?
A4: Yes. The patent family includes continuation applications that could lead to new filings, extending exclusivity.

Q5: How does this patent compare to others in the same class?
A5: It has narrower compound claims but broader treatment claims than some prior art, with a strategic focus on specific derivatives.


References

[1] United States Patent and Trademark Office. "U.S. Patent No. 10,561,672." (2019).

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Drugs Protected by US Patent 10,561,672

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Glenmark Speclt RYALTRIS mometasone furoate; olopatadine hydrochloride SPRAY, METERED;NASAL 211746-001 Jan 13, 2022 RX Yes Yes 10,561,672 ⤷  Start Trial Y ⤷  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: 10,561,672

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
India2975/MUM/2013Sep 13, 2013

International Family Members for US Patent 10,561,672

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 3043773 ⤷  Start Trial CA 2021 00050 Denmark ⤷  Start Trial
European Patent Office 3043773 ⤷  Start Trial 301154 Netherlands ⤷  Start Trial
European Patent Office 3043773 ⤷  Start Trial 122021000085 Germany ⤷  Start Trial
European Patent Office 3043773 ⤷  Start Trial 132021000000191 Italy ⤷  Start Trial
European Patent Office 3043773 ⤷  Start Trial 57/2021 Austria ⤷  Start Trial
European Patent Office 3043773 ⤷  Start Trial 2022C/520 Belgium ⤷  Start Trial
European Patent Office 3043773 ⤷  Start Trial C202130060 Spain ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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