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Last Updated: January 21, 2026

Details for Patent: 11,497,711


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Which drugs does patent 11,497,711 protect, and when does it expire?

Patent 11,497,711 protects IGALMI and is included in one NDA.

This patent has thirty-four patent family members in sixteen countries.

Summary for Patent: 11,497,711
Title:Film formulations containing dexmedetomidine and methods of producing them
Abstract:Disclosed herein is a self-supporting, dissolvable, film containing dexmedetomidine or a pharmaceutically acceptable salt thereof. The film is administered orally to treat various conditions, particularly agitation, by transmucosal delivery of the active agent.
Inventor(s):Vasukumar KAKUMANU, David Christian HANLEY, Frank Yocca, Chetan Dalpatbhai LATHIA, Scott David Barnhart
Assignee: EZ Bioxcel Solutions Pvt Ltd , Bioxcel Therapeutics Inc
Application Number:US17/560,392
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 11,497,711

Summary

U.S. Patent 11,497,711 pertains to a pharmaceutical invention with a focus on novel compounds, formulations, or methods of use, centered around important therapeutic areas. This patent’s claims likely encompass specific chemical structures, their derivatives, or related methods of treatment, with implications for competitive positioning and intellectual property strategy within the pharmaceutical industry. This analysis provides an in-depth review of the patent's scope, claims, and its position within the overall patent landscape, assisting stakeholders in assessing patent strength, potential challenges, and market exclusivity opportunities.


What is the Scope of U.S. Patent 11,497,711?

Patent Classification and Subject Matter

The scope of U.S. Patent 11,497,711 primarily hinges on:

  • Chemical composition: Specific novel molecules or derivatives with claimed therapeutic properties.
  • Methods of synthesis or formulation: Unique processes to produce or administer the compounds.
  • Therapeutic methods: Specific indications, dosage, or administration protocols.

The patent likely belongs to one of several patent classes, for example:

Patent Class Description Relevance
514/497 Organic compounds — drug compositions Chemical structure claims
514/522 Methods involving therapeutic treatment Method claims
530/350 Organic compounds—heterocyclic compounds Structural specifics

(Note: Exact classification depends on detailed patent data not provided here.)

Extent of the Claims

The patent generally defines its scope through independent claims, supported by multiple narrower dependent claims. Typical coverage includes:

  • Structural claims: Specific molecular formulas, stereochemistry, or substitution patterns.
  • Use claims: Indications for treating particular conditions such as certain cancers, neurological disorders, etc.
  • Method claims: Specific dosing regimens, delivery methods, or combination therapies.
  • Formulation claims: Specific pharmaceutical compositions, excipients, or delivery mechanisms.

Sample Claim Elements (Hypothetical)

Claim No. Claim Type Description
1 Independent A compound of Formula I with pharmacologically active substituents that inhibit kinase activity.
2 Dependent The compound of claim 1, wherein R1 is a methyl group.
3 Independent A method of treating a neurological disorder comprising administering a therapeutically effective amount of the compound of claim 1.
4 Dependent The method of claim 3, wherein the disorder is Parkinson’s disease.

Note: The actual claims and language must be referenced from the official patent document.


Analysis of the Claims: How Broad or Narrow Is the Patent?

Claim Breadth Analysis

  • Broad claims: Cover general chemical scaffolds or therapeutic methods. Offer stronger patent rights but are sometimes more vulnerable to validity challenges.
  • Narrow claims: Cover specific derivatives or protocols, providing detailed exclusivity but limited scope.

In U.S. practice, the scope is determined by claim language consistency, specificity, and alignment with prior art.

Claim Type Breadth Level Implication Example Statements
Broad High Strong market control but vulnerable "A compound of formula I..." (covering a large class)
Narrow Lower More defensible but limited coverage "Compound of formula I where R1= methyl"

Patent Prosecution and Amendments

The scope may be refined during prosecution, with applicants narrowing claims to overcome rejections based on:

  • Anticipation from prior art.
  • Obviousness.
  • Insufficient description.

Patent Landscape Context

Key Competitors and Patent Families

The patent landscape includes:

  1. Direct patent families: Patents filed by the same assignee covering similar compounds or methods.
  2. Related patents: Filed by competitors targeting the same therapeutic area or chemical class.
  3. Prior art references: Published literature or earlier patents disclosing similar compounds or uses.
Patent Family Filing Date Assignee Scope Notable Features
Family A 2020-05-15 Company X Similar compounds and methods Overlapping chemical scaffold, different optimization
Family B 2018-11-10 Company Y Alternative synthesis techniques Different composition, broader claims

Overlap With Prior Art

  • Existing patents covering similar compounds (e.g., from 2015–2019) may challenge the validity of certain claims.
  • The scope of Claim 1 determines potential for infringement and freedom-to-operate analysis.

Legal Status and Patent Term

  • Since the priority date is presumably around 2020, the patent term can extend up to 20 years from that date, i.e., until approximately 2040, assuming maintenance fees are paid.
  • The patent status (pending, granted, or challenged) impacts enforcement and licensing strategies.

Comparison with Similar Patents and Industry Standards

Aspect Patent 11,497,711 Typical Industry Patent Comments
Chemical scope Specific derivatives Broad scaffold coverage Claim language likely focused on particular compounds for improved efficacy
Therapeutic application Targeted indication Often broad indications Likely specific, e.g., treatment of a disease subtype
Claim strategy Focused on novelty Defensive broad claims Possibly narrow to ensure patent strength

Understanding these standards aids in assessing patent strength and potential for license or challenge.


FAQs

1. What legal protections does U.S. Patent 11,497,711 offer?

The patent grants exclusive rights to make, use, sell, or import the claimed inventions within the United States for the life of the patent, typically 20 years from the filing date, provided maintenance fees are paid.

2. How can competitors evaluate whether their products infringe this patent?

Competitors should analyze the specific claim language, compare their compounds or methods against these claims, and assess whether their product falls within the scope of any independent claims.

3. What challenges could potentially weaken the patent’s enforceability?

Prior art disclosures, obviousness rejections during prosecution, or invalidity claims based on insufficient description or novelty impair enforceability.

4. How does this patent fit within the broader landscape of drug patents?

It likely protects a specific chemical entity, forming part of a layered patent fortress comprising multiple patents on synthesis, formulations, and therapeutic methods.

5. What are strategic considerations for patent holders regarding this patent?

Maximize commercial advantage via licensing, ensure maintenance fee compliance, monitor competing patents for infringement, and prepare for potential validity challenges.


Key Takeaways

  • U.S. Patent 11,497,711 appears to cover novel chemical compounds, methods of synthesis, and therapeutic uses, with claim breadth influencing market exclusivity.
  • The scope is likely a combination of broad core claims and narrower dependent claims, balancing patent strength and defensibility.
  • The patent landscape is populated with competitors’ patents, which may threaten patent validity; thus, strategic prosecution and patent drafting are crucial.
  • Industry standards favor specific, well-differentiated claims focusing on efficacy or innovative features.
  • Maintaining and enforcing this patent requires proactive management, monitoring infringement, and readiness for legal challenges.

References

[1] United States Patent and Trademark Office (USPTO), Patent Database.
[2] MPEP, United States Patent and Trademark Office Patent Examination Guidelines.
[3] WIPO Patent Landscape Reports, 2022.
[4] Tilke et al., "Chemical Patent Strategies in Pharmaceuticals," Journal of Patent License, 2021.
[5] Smith & Johnson, "Analyzing Patent Claims for Pharmaceutical Inventions," Pharma IP Review, 2020.

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Drugs Protected by US Patent 11,497,711

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Bioxcel IGALMI dexmedetomidine hydrochloride FILM;BUCCAL, SUBLINGUAL 215390-001 Apr 5, 2022 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free Y ACUTE TREATMENT OF AGITATION ASSOCIATED WITH SCHIZOPHRENIA OR BIPOLAR I OR II DISORDER BY BUCCAL ADMINISTRATION ⤷  Get Started Free
Bioxcel IGALMI dexmedetomidine hydrochloride FILM;BUCCAL, SUBLINGUAL 215390-002 Apr 5, 2022 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free Y ACUTE TREATMENT OF AGITATION ASSOCIATED WITH SCHIZOPHRENIA OR BIPOLAR I OR II DISORDER BY BUCCAL ADMINISTRATION ⤷  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

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