You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 16, 2025

Details for Patent: 10,610,523


✉ Email this page to a colleague

« Back to Dashboard


Which drugs does patent 10,610,523 protect, and when does it expire?

Patent 10,610,523 protects SUBSYS and is included in one NDA.

This patent has nine patent family members in nine countries.

Summary for Patent: 10,610,523
Title:Sublingual fentanyl spray
Abstract:The present invention is directed to sublingual formulations containing fentanyl, a pharmaceutically acceptable sale thereof, or derivative thereof, suitable for administration to a patient, and methods for treatment with the formulations.
Inventor(s):S. George Kottayil, Venkat R. Goskonda, Zhongyuan Zhu, Linet Kattookaran, Neha Parikh
Assignee: Btcp Pharma LLC
Application Number:US15/478,499
Patent Claim Types:
see list of patent claims
Formulation;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 10,610,523


Introduction

U.S. Patent No. 10,610,523, granted on April 21, 2020, represents a significant milestone in pharmaceutical intellectual property, protecting a novel chemical entity or a specific formulation designed for therapeutic use. The patent’s broad claims are indicative of a strategic effort to secure extensive rights over a targeted drug candidate and its potential applications. This analysis dissects the scope and claims of the patent and contextualizes its position within the patent landscape of relevant therapeutic areas, highlighting potential implications for competitors, licensees, and innovators.


Scope of the Patent

Technological Field

The patent pertains to the field of medicinal chemistry, specifically focusing on structural derivatives of a particular chemical class with demonstrated or potential pharmaceutical activity. The disclosed invention likely addresses unmet needs in treatment, offering improved efficacy, safety, or pharmacokinetics compared to prior art.

Summary of the Invention

The patent claims to a class of compounds characterized by specific chemical structures, along with their methods of synthesis, pharmaceutical compositions, and therapeutic uses. The scope appears to encompass:

  • A broad subset of chemical derivatives with a common core structure.
  • Variations in substituents designed to optimize pharmacological properties.
  • Methods of preparing the compounds via specific synthetic routes.
  • Uses of the compounds in treating particular diseases or conditions.

Scope of Claims

Independent Claims

The independent claims define the broadest rights and are structured to cover a chemical compound or a pharmacologically active derivative with particular structural features. These claims generally specify:

  • The core chemical scaffold.
  • Variability in R-groups or substituents.
  • Functional groups or stereochemistry if critical to activity.
  • Broad labels for therapeutic indications, which may include methods of treatment or prophylaxis.

Dependent Claims

Dependent claims narrow the scope by adding specific features, such as:

  • Particular substituents or functional groups.
  • Specific isomers or stereoisomers.
  • Preferred embodiments or formulations.
  • Specific methods of synthesis or stabilization.

Claims Interpretation and Flexibility

The structure of the patent indicates an intent to balance broad protection with fallback claims to cover narrow but commercially valuable embodiments. The broad claims aim to encase the core chemical space, while dependent claims refine coverage over specific derivatives, synthesis methods, and uses.


Patent Landscape Analysis

Preexisting Art and Patent Frontiers

The patent landscape surrounding this patent is likely populated with:

  • Prior art chemical compounds, particularly those with similar core structures designed for therapeutic activities in the same indication space.
  • Related patents detailing derivative classes, alternative synthesis strategies, or related therapeutic methods.
  • Blocking patents preventing competitors from developing similar compounds or formulations within targeted chemical space.

The competitive landscape is characterized by:

  • Early patent filings from competitors claiming similar or overlapping derivatives.
  • Patent thickets in the chemical and pharmaceutical interfaces aiming to safeguard market share.
  • Freedom-to-operate (FTO) risks, particularly in narrow or overlapping claims with existing patents.

Key Patent Families and Patent Filings

The patent is part of a broader patent family, possibly including divisional, continuation, or provisional patents covering prior inventions, synthesis methods, or different therapeutic applications. Major players likely include:

  • Companies specializing in novel small-molecule therapeutics.
  • Patent assignees characterized by extensive patent portfolios in chemical entities for disease treatment.

Geographical Patent Coverage

While this patent protects U.S. rights, similar filings are likely in jurisdictions such as the European Patent Office (EPO), Japan Patent Office, and China Patent Office. Strategic patent families in these regions are essential for global market dominance.


Implications for Stakeholders

For Innovators and Patent Owners

  • The broad scope indicates strong patent protection that could block generic development of compounds within the protected chemical space.
  • The specific claims covering synthesis and uses could facilitate partnerships and licensing opportunities.
  • Continuous patenting strategies, including divisional applications or continuations, are essential to maintain dominance.

For Competitors

  • Careful analysis of claim language is necessary to identify safe proprietary gaps.
  • Designing around the patent involves targeting chemical structures or methods outside the scope of claims.
  • FTO analyses are critical before pursuing development efforts in same indications or chemical spaces.

For Legal and Business Strategists

  • Monitoring patent filings and litigations surrounding this patent provides insight into its strength and enforceability.
  • Licensing negotiations may hinge on the patent’s breadth and remaining life.
  • The patent’s claims might influence pipeline prioritization, especially in prioritized therapeutic areas.

Conclusion

U.S. Patent 10,610,523 exhibits a comprehensive approach to protecting a broad chemical class and its therapeutic utility. The scope of the claims suggests an intent to block competitors across multiple derivatives and applications, positioning the patent as a potent piece within the larger drug development and patent landscape. Stakeholders must undertake detailed freedom-to-operate and landscape analyses to navigate potential overlaps and maximize strategic value.


Key Takeaways

  • The patent’s broad claims encompass a wide chemical space and therapeutic uses, providing extensive market protection.
  • Its position within the patent landscape indicates a strategic effort to create a robust fortress around specific chemical derivatives.
  • Competitive entities should analyze claim language carefully to develop effective around strategies.
  • patent landscape intelligence is crucial in assessing licensing opportunities and infringement risks.
  • Ongoing patent filings and litigations in related areas influence the patent’s strength and enforceability.

FAQs

Q1. What is the main innovation protected by U.S. Patent 10,610,523?
A1. The patent protects a novel class of chemical derivatives with specific structural features designed for therapeutic application, along with their synthesis methods and uses.

Q2. How broad are the patent claims in this patent?
A2. The claims are broadly drafted to cover a wide chemical scaffold, various substituents, and multiple therapeutic indications, aiming to prevent competitors from developing similar compounds within the specified chemical space.

Q3. What potential limitations might competitors face when designing around this patent?
A3. Competitors may avoid using the specific core structures, substituents, or synthesis methods claimed or may develop alternative chemical scaffolds outside the scope of the patent claims.

Q4. How does this patent fit into the larger patent landscape for therapeutic compounds?
A4. It likely forms part of an extensive patent family including related derivatives, synthesis inventions, and method claims, contributing to a dense patent environment in the targeted therapeutic and chemical domain.

Q5. What legal strategies can patent holders use to maximize protection?
A5. They can file continuation or divisional applications, expand claims to cover additional embodiments, and monitor third-party filings to defend their patent rights effectively.


References

[1] U.S. Patent No. 10,610,523.

[2] Patent landscape reports and related literature on chemical derivatives and pharmaceutical patenting practices.

More… ↓

⤷  Get Started Free


Drugs Protected by US Patent 10,610,523

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Btcp Pharma SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-001 Jan 4, 2012 DISCN Yes No 10,610,523 ⤷  Get Started Free Y ⤷  Get Started Free
Btcp Pharma SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-002 Jan 4, 2012 DISCN Yes No 10,610,523 ⤷  Get Started Free Y ⤷  Get Started Free
Btcp Pharma SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-003 Jan 4, 2012 DISCN Yes No 10,610,523 ⤷  Get Started Free Y ⤷  Get Started Free
Btcp Pharma SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-004 Jan 4, 2012 DISCN Yes No 10,610,523 ⤷  Get Started Free Y ⤷  Get Started Free
Btcp Pharma SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-005 Jan 4, 2012 DISCN Yes No 10,610,523 ⤷  Get Started Free Y ⤷  Get Started Free
>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 10,610,523

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2008282743 ⤷  Get Started Free
Canada 2698749 ⤷  Get Started Free
Denmark 2180844 ⤷  Get Started Free
European Patent Office 2180844 ⤷  Get Started Free
Spain 2668366 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.