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 eight patents protecting this drug.
This drug has fifty patent family members in fourteen 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 MYLAN INSTITUTIONAL on August 18th, 2014.
Summary for IGALMI
International Patents: | 50 |
US Patents: | 8 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 100 |
Patent Applications: | 233 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for IGALMI |
What excipients (inactive ingredients) are in IGALMI? | IGALMI excipients list |
DailyMed Link: | IGALMI at DailyMed |
Pharmacology for IGALMI
Drug Class | Central alpha-2 Adrenergic Agonist |
Mechanism of Action | Adrenergic alpha2-Agonists |
Physiological Effect | General Anesthesia |
Anatomical Therapeutic Chemical (ATC) Classes for IGALMI
US Patents and Regulatory Information for IGALMI
IGALMI is protected by eight US patents and one FDA Regulatory Exclusivity.
Patents protecting IGALMI
Film formulations containing dexmedetomidine and methods of producing them
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: ACUTE TREATMENT OF AGITATION ASSOCIATED WITH SCHIZOPHRENIA OR BIPOLAR I OR II DISORDER BY SUBLINGUAL ADMINISTRATION
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: ACUTE TREATMENT OF AGITATION ASSOCIATED WITH SCHIZOPHRENIA OR BIPOLAR I OR II DISORDER BY BUCCAL ADMINISTRATION
Film formulations containing dexmedetomidine and methods of producing them
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: ACUTE TREATMENT OF AGITATION ASSOCIATED WITH SCHIZOPHRENIA OR BIPOLAR I OR II DISORDER BY BUCCAL ADMINISTRATION
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: ACUTE TREATMENT OF AGITATION ASSOCIATED WITH SCHIZOPHRENIA BY SUBLINGUAL OR BUCCAL ADMINISTRATION
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: ACUTE TREATMENT OF AGITATION ASSOCIATED WITH BIPOLAR I OR II DISORDER BY SUBLINGUAL OR BUCCAL ADMINISTRATION
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: ACUTE TREATMENT OF AGITATION ASSOCIATED WITH BIPOLAR I OR II DISORDER BY SUBLINGUAL OR BUCCAL ADMINISTRATION
FDA Regulatory Exclusivity protecting IGALMI
NEW PRODUCT
Exclusivity Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Bioxcel | IGALMI | dexmedetomidine hydrochloride | FILM;BUCCAL, SUBLINGUAL | 215390-002 | Apr 5, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Bioxcel | IGALMI | dexmedetomidine hydrochloride | FILM;BUCCAL, SUBLINGUAL | 215390-001 | Apr 5, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Bioxcel | IGALMI | dexmedetomidine hydrochloride | FILM;BUCCAL, SUBLINGUAL | 215390-001 | Apr 5, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Bioxcel | IGALMI | dexmedetomidine hydrochloride | FILM;BUCCAL, SUBLINGUAL | 215390-002 | Apr 5, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Bioxcel | IGALMI | dexmedetomidine hydrochloride | FILM;BUCCAL, SUBLINGUAL | 215390-001 | Apr 5, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
>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.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
China | 114983980 | 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) | ⤷ Try a Trial |
Taiwan | I791479 | ⤷ Try a Trial | |
Japan | 2024014900 | 激越の治療のための舌下デクスメデトミジンの使用 | ⤷ Try a Trial |
Taiwan | 201829018 | Use of sublingual DEXMEDETOMIDINE for the treatment of agitation | ⤷ Try a Trial |
Japan | 2022040229 | 激越の治療のための舌下デクスメデトミジンの使用 | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 2020006092 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for IGALMI
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0300652 | C300117 | Netherlands | ⤷ Try a Trial | 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 |
0300652 | 2003C/005 | Belgium | ⤷ Try a Trial | PRODUCT NAME: CHLORHYDRATE DE DEXMEDETOMIDINE; REGISTRATION NO/DATE: EU/2/02/033/001 20020903 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |