IGALMI Drug Patent Profile

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When do Igalmi patents expire, and what generic alternatives are available?

Igalmi is a drug marketed by Bioxcel and is included in one NDA. There are eleven patents protecting this drug.

This drug has sixty-seven patent family members in sixteen countries.

The generic ingredient in IGALMI is dexmedetomidine hydrochloride. There are fourteen drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the dexmedetomidine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Igalmi

A generic version of IGALMI was approved as dexmedetomidine hydrochloride by ENDO OPERATIONS on August 18^th, 2014.

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Summary for IGALMI

International Patents:	67
US Patents:	11
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	100
Clinical Trials:	3
Patent Applications:	222
Drug Prices:	Drug price information for IGALMI
What excipients (inactive ingredients) are in IGALMI?	IGALMI excipients list
DailyMed Link:	IGALMI at DailyMed

Drug patent expirations by year for IGALMI

Recent Clinical Trials for IGALMI

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
NYU Langone Health	Phase 2
BioXcel Therapeutics Inc	Phase 4
Lotus Clinical Research, LLC	Phase 4

See all IGALMI clinical trials

Pharmacology for IGALMI

Drug Class	Central alpha-2 Adrenergic Agonist
Mechanism of Action	Adrenergic alpha2-Agonists
Physiological Effect	General Anesthesia

US Patents and Regulatory Information for IGALMI

IGALMI is protected by twelve US patents and one FDA Regulatory Exclusivity.

Patents protecting IGALMI

Film formulations containing dexmedetomidine and methods of producing them
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Patented Use: ACUTE TREATMENT OF AGITATION ASSOCIATED WITH SCHIZOPHRENIA OR BIPOLAR I OR II DISORDER BY SUBLINGUAL ADMINISTRATION

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Patented Use: ACUTE TREATMENT OF AGITATION ASSOCIATED WITH SCHIZOPHRENIA OR BIPOLAR I OR II DISORDER BY BUCCAL ADMINISTRATION

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Patented Use: ACUTE TREATMENT OF AGITATION ASSOCIATED WITH SCHIZOPHRENIA BY SUBLINGUAL OR BUCCAL ADMINISTRATION

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Patented Use: ACUTE TREATMENT OF AGITATION ASSOCIATED WITH SCHIZOPHRENIA OR BIPOLAR I OR II DISORDER BY SUBLINGUAL OR BUCCAL ADMINISTRATION IN PATIENTS WITH SEVERE HEPATIC IMPAIRMENT

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Patented Use: ACUTE TREATMENT OF AGITATION ASSOCIATED WITH BIPOLAR I OR II DISORDER BY SUBLINGUAL OR BUCCAL ADMINISTRATION

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Patented Use: A METHOD OF TREATING AGITATION ASSOCIATED WITH SCHIZOPHRENIA OR BIPOLAR I OR II DISORDER

FDA Regulatory Exclusivity protecting IGALMI

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bioxcel	IGALMI	dexmedetomidine hydrochloride	FILM;BUCCAL, SUBLINGUAL	215390-001	Apr 5, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bioxcel	IGALMI	dexmedetomidine hydrochloride	FILM;BUCCAL, SUBLINGUAL	215390-002	Apr 5, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Bioxcel	IGALMI	dexmedetomidine hydrochloride	FILM;BUCCAL, SUBLINGUAL	215390-002	Apr 5, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bioxcel	IGALMI	dexmedetomidine hydrochloride	FILM;BUCCAL, SUBLINGUAL	215390-001	Apr 5, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Bioxcel	IGALMI	dexmedetomidine hydrochloride	FILM;BUCCAL, SUBLINGUAL	215390-001	Apr 5, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for IGALMI

See the table below for patents covering IGALMI around the world.

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Country	Patent Number	Title	Estimated Expiration
Japan	2020503323	激越の治療のための舌下デクスメデトミジンの使用	⤷ Sign Up
Denmark	3562486		⤷ Sign Up
Taiwan	I833550		⤷ Sign Up
Japan	2022540706	鎮静作用のないデクスメデトミジン治療レジメン	⤷ Sign Up
China	115154440	含右美托咪定的膜制剂及其制造方法 (Film formulations containing dexmedetomidine and methods of making same)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for IGALMI

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0300652	2003C/005	Belgium	⤷ Sign Up	PRODUCT NAME: CHLORHYDRATE DE DEXMEDETOMIDINE; REGISTRATION NO/DATE: EU/2/02/033/001 20020903
0300652	C300117	Netherlands	⤷ Sign Up	PRODUCT NAME: DEXMEDETOMIDINE, DESGEWENST IN DE VORM VAN EEN NIET-TOXISCH IN FARMACEUTISCH OPZICHT AANVAARDBAAR ZUURADDITIEZOUT, IN HET BIJZ ONDER DEXMEDETOMIDINE HYDROCHLORIDE; REGISTRATION NO/DATE: EU/2/02/033/001 20020830
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description