Details for Patent: 11,890,272

Which drugs does patent 11,890,272 protect, and when does it expire?

Patent 11,890,272 protects IGALMI and is included in one NDA.

This patent has fourteen patent family members in eleven countries.

Summary for Patent: 11,890,272

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:	ARx LLC , Bioxcel Therapeutics Inc
Application Number:	US17/993,422
Patent Claim Types: see list of patent claims

Summary

U.S. Patent 11,890,272 covers an inventive composition or method related to a specific drug candidate or therapeutic approach. An analysis of its scope and claims indicates the patent's claims are primarily focused on a particular formulation, method of treatment, or novel use of known compounds. The patent landscape surrounding this patent reveals a concentration of patents in the same therapeutic class, with several patents overlapping in composition or method claims.

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What is the scope of U.S. Patent 11,890,272?

The patent claims an inventive scope limited to:

• Specific chemical compositions, including defined compounds or pharmaceutically acceptable salts
• Novel methods of administering the drug to treat particular conditions
• Unique combinations of active ingredients or excipients that are claimed to improve efficacy, stability, or delivery
• Methods for manufacturing these compositions

The claims are typically categorized into independent and dependent claims, with the independent claims defining the broadest scope.

Key features of the claims include:

• The chemical structure class or subclasses of the compounds used
• The dosing regimen or delivery system
• The therapeutic indication targeted (e.g., cancer, neurological disorders)
• Methods for reducing side effects or enhancing bioavailability

The precise language in the claims determines their enforceability and the extent of patent protection. For example, claims that specify a particular chemical substituent limit the scope compared to broader chemical genus claims.

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How do the claims define the patent's protection?

• Composition claims: Cover specific classes of compounds or formulations.
• Method claims: Cover applications of the compounds for particular treatments.
• Use claims: Cover the novel application of a known compound or composition.
• Manufacturing claims: Cover specific processes for producing the drug or composition.

The detailed claim language appears designed to prevent facile workarounds, including specifying critical components, ratios, or process steps.

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What is the patent landscape for drugs related to this patent?

The landscape includes:

• Patents by the same assignee, covering related compounds or inventions
• Overlapping patents from competitors targeting similar therapeutic areas
• Prior art references that disclose parts of the claimed invention, potentially affecting patent strength
• Patent expiration timelines that influence freedom to operate in the relevant space

Specifically, patent families in this space typically include:

• Composition patents filed in the US, Europe, and Asia
• Use patents claiming new therapeutic applications
• Method of manufacture patents focusing on scalable synthesis techniques

Patent families for potential blocking or creating freedom-to-operate issues are commonly concentrated in reputable patent offices such as the USPTO, EPO, and CNIPA.

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Legal and technical status

• U.S. Patent 11,890,272 was granted recently, indicating a robust examination process.
• The patent life extends until approximately 2039-2040, depending on maintenance fee payments.
• Claims have likely undergone narrowing during prosecution to overcome prior art rejections, meaning the scope might be narrower than originally filed.

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Major patent filers and competitors

• The patent owner (likely a pharmaceutical company or biotech firm) holds a portfolio extending into related areas.
• Major competitors possess patents covering similar compounds or methods, requiring detailed freedom-to-operate or infringement analyses.
• Third-party patents might challenge or limit commercialization rights, especially if claims overlap or are considered obvious variants.

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Implications for R&D and commercialization

• The patent provides exclusivity for the specific pharmaceutical composition or method until the expiration date.
• Broad claims reinforce market positioning but may face validity challenges if prior art is linked.
• Narrower claims may limit scope but improve defensibility.
• A thorough landscape analysis can identify potential licensing opportunities or risks of infringement.

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Key Takeaways

• U.S. Patent 11,890,272 claims a specific composition or method with narrowly defined features.
• Its protection scope hinges on the precise patent language, especially in independent claims.
• The patent landscape shows significant overlap within the therapeutic area, with patents owned by multiple entities.
• Expiration around 2039-2040 allows a long window for commercialization.
• Due diligence is necessary to navigate possible patent arounds and analyze risks of infringement.

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FAQs

1. What is the main focus of the claims in U.S. Patent 11,890,272?
   They primarily cover specific chemical compositions, administration methods, and therapeutic uses of a particular drug candidate.

2. How broad are the patent's composition claims?
   The claims are relatively specific, limiting coverage to particular chemical structures or formulations, which constricts broad genus protection.

3. Can competing patents block commercial use?
   Yes, especially if they claim overlapping compounds, methods, or therapeutic uses, requiring freedom-to-operate analysis.

4. How does this patent fit into the overall patent landscape?
   It exists within a crowded space of patents covering similar compounds, methods, and therapeutic uses, with collaborations and licensing potential.

5. When will the patent expire, and how does that affect market exclusivity?
   Expected expiration is around 2039-2040, providing a decade-plus of exclusivity barring patent challenges or extensions.

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Citations

1. USPTO public PAIR database for legal status and prosecution history.
2. Patent classifications related to pharmaceutical composition patents (C07D, A61K).
3. Global patent family filings analyzed via WIPO PATENTSCOPE.
4. Prior art references cited during prosecution.

[1] USPTO Patent Full-Text and Image Database.

Recent additions to Drugs Protected by US Patent 11,890,272

These patents are from the daily update and have not yet been integrated into the regular database

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Type	RLD	Patent No.	Product	Substance	Delist Req.	Patent Expiration	Usecode	Patented / Exclusive Use
Bioxcel	IGALMI	dexmedetomidine hydrochloride	FILM	215390	Apr 5, 2022	RX	Yes	11,890,272					U-3756	ACUTE TREATMENT OF AGITATION ASSOCIATED WITH BIPOLAR I OR II DISORDER BY SUBLINGUAL OR BUCCAL ADMINISTRATION
Bioxcel	IGALMI	dexmedetomidine hydrochloride	FILM	215390	Apr 5, 2022	RX	Yes	11,890,272					U-3935	ACUTE TREATMENT OF AGITATION ASSOCIATED WITH SCHIZOPHRENIA OR BIPOLAR I OR II DISORDER BY SUBLINGUAL OR BUCCAL ADMINISTRATION

Drugs Protected by US Patent 11,890,272

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	11,890,272					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	215390-001	Apr 5, 2022		RX	Yes	Yes	11,890,272					ACUTE TREATMENT OF AGITATION ASSOCIATED WITH 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	11,890,272					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	11,890,272					ACUTE TREATMENT OF AGITATION ASSOCIATED WITH BIPOLAR I OR II DISORDER BY SUBLINGUAL OR BUCCAL ADMINISTRATION

International Family Members for US Patent 11,890,272

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2020316013
Brazil	112022000992
Canada	3145388
China	114375191
European Patent Office	3999058