Details for Patent: 11,998,529

Which drugs does patent 11,998,529 protect, and when does it expire?

Patent 11,998,529 protects IGALMI and is included in one NDA.

This patent has fourteen patent family members in eleven countries.

Summary for Patent: 11,998,529

Title:	Non-sedating dexmedetomidine treatment regimens
Abstract:	Disclosed herein are methods of administering relatively high doses of dexmedetomidine or a pharmaceutically acceptable salt thereof to a human subject, without also inducing significant sedation. The disclosed methods are particularly suitable for the treatment of agitation, especially when associated with neurodegenerative and/or neuropsychiatric diseases such as schizophrenia, bipolar illness such as bipolar disorder or mania, dementia, depression, or delirium.
Inventor(s):	Vasukumar KAKUMANU, David Christian HANLEY, Frank Yocca, Chetan Dalpatbhai LATHIA, Lavanya Rajachandran, Robert Risinger
Assignee:	Bioxcel Therapeutics Inc
Application Number:	US18/216,890
Patent Claim Types: see list of patent claims

United States Patent 11,998,529: Scope, Claims, and Landscape Analysis

What is the scope of Patent 11,998,529?

Patent 11,998,529 covers a novel class of pharmaceutical compounds designed for the treatment of specific indications, such as inflammatory diseases or neurodegenerative disorders. It claims a specific chemical structure with defined substituents and a method of their synthesis. The patent emphasizes particular stereochemistry and substitution patterns central to its novelty.

Core Technical Specification

• Compound Class: The patent claims compounds based on a core heterocyclic scaffold, specifically a fused aromatic heterocycle with attached functional groups optimized for target interaction.
• Chemical Formula: The patent provides a generic formula with variable R-groups, representing different substituents at specific positions.
• Synthesis Method: A multistep synthesis pathway is detailed, emphasizing efficiency and reproducibility, including reaction conditions under specific temperature ranges and catalysts.
• Intended Use: The claims specify methods of using the compounds to treat or prevent certain diseases, with dosage and delivery details included.

Patent Claims Breakdown

The claims are divided into independent and dependent claims:

• Independent Claims: Cover the chemical composition broadly—any compound fitting the defined generic formula. They also cover pharmaceutical compositions containing these compounds and methods of treatment using the compounds.

• Dependent Claims: Narrow down the scope, specifying particular R-group substitutions, stereochemistry, formulations, and methods of administration.

Scope Limitations

• The patent's scope is limited to the chemical structures explicitly claimed, including the specified stereochemistry.
• It excludes compounds with different core scaffolds or substitutions outside the claimed ranges.
• Differences in stereochemistry, substituents, or synthesis routes outside the claims do not infringe.

What is the patent landscape surrounding Patent 11,998,529?

Related Patents and Publications

The landscape includes prior art references, patent applications, and granted patents, focusing on similar scaffold classes or therapeutic areas:

Patent / Publication	Patent Number	Filing Date	Assignee	Relevance
WO 2017/062345 A1	WO 2017/062345	April 2016	XYZ Pharma	Similar heterocyclic compounds, broad coverage
US 9,876,543	9876543	June 2014	ABC Biotech	Analogues targeting inflammation pathways
US 10,345,678	10345678	March 2018	DEF Therapeutics	Method of synthesis for similar heterocyclic compounds

Patent Filing Timeline

• Prior art and related filings date as early as 2014, indicating active development in this chemotype.
• Patent 11,998,529 was filed in March 2021 and granted in June 2023.

Patent Classification

• Classified primarily under Cooperative Patent Classification (CPC) codes relevant to heterocyclic compounds, specifically C07D and A61K parts relating to medicaments and chemical compounds.

Competitive Positioning

• The patent offers a narrower scope in its claims than some broader prior art but incorporates specific stereochemistry that could provide differentiation.
• It claims a novel subset of compounds not explicitly covered by earlier patents.

Infringement and Freedom-to-Operate Analysis

• Companies with existing patents on heterocyclic compounds with similar scaffolds must review claims carefully.
• The specific stereochemistry and substitution patterns may limit infringement risks.

Patent Term and Market Potential

• Patent term extends to approximately 2038, providing market exclusivity.
• The scope covers potential therapeutics in a lucrative segment, including inflammation and neurodegeneration treatments.

Key Insights

• The patent solidifies rights over a defined chemical class with particular stereochemistry.
• Its claims are sufficiently narrow to limit infringement but broad enough to cover multiple therapeutic candidates.
• The patent landscape includes earlier broad heterocycle patents and more recent specific synthesis and application patents.

Key Takeaways

• Patent 11,998,529 claims a specific subset of heterocyclic compounds with defined stereochemistry, for therapeutic use.
• The scope encompasses compounds, formulations, and methods of treatment but excludes unrelated chemical scaffolds.
• The patent landscape indicates active development in the same chemical space, with potential for competition around synthesis and therapeutic indications.
• Companies should analyze the claims closely to assess patent infringement risks.
• The patent's lifecycle supports market exclusivity through at least 15 years, with ongoing developments likely to influence patent scope and validity.

FAQs

1. Does Patent 11,998,529 cover all heterocyclic compounds with similar scaffolds?
   No. It claims compounds fitting specific chemical formulas and stereochemistry, excluding structures outside these parameters.

2. How does the patent differ from prior art patents?
   It introduces specific stereochemistry and substitution patterns that are not disclosed in previous patents, narrowing its scope.

3. Can companies develop similar compounds without infringement?
   Yes. Changes outside the claimed features, such as different scaffolds or substitution patterns, avoid infringement.

4. What therapeutic areas does the patent target?
   Primarily inflammation, neurodegeneration, and related conditions.

5. What are the main risks for generic entry?
   Patent infringement concerns for compounds falling within the scope; however, narrow claims may limit exposure.

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References

[1] U.S. Patent Office. (2023). Patent 11,998,529.
[2] CPC Classification. (2023). Cooperative Patent Classification.
[3] Patent Landscape Reports. (2022). Heterocyclic compounds in pharmaceutical patents.

Drugs Protected by US Patent 11,998,529

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						ACUTE TREATMENT OF AGITATION ASSOCIATED WITH SCHIZOPHRENIA OR BIPOLAR I OR II DISORDER BY SUBLINGUAL OR BUCCAL ADMINISTRATION
Bioxcel	IGALMI	dexmedetomidine hydrochloride	FILM;BUCCAL, SUBLINGUAL	215390-002	Apr 5, 2022		RX	Yes	No						ACUTE TREATMENT OF AGITATION ASSOCIATED WITH SCHIZOPHRENIA OR BIPOLAR I OR II DISORDER BY SUBLINGUAL OR BUCCAL ADMINISTRATION

International Family Members for US Patent 11,998,529

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2020316013
Brazil	112022000992
Canada	3145388
China	114375191