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 twelve 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 18th, 2014.
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Questions you can ask:
- What is the 5 year forecast for IGALMI?
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Summary for IGALMI
International Patents: | 67 |
US Patents: | 12 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 100 |
Clinical Trials: | 3 |
Patent Applications: | 242 |
Drug Prices: | Drug price information for IGALMI |
What excipients (inactive ingredients) are in IGALMI? | IGALMI excipients list |
DailyMed Link: | IGALMI at DailyMed |
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 |
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 thirteen US patents and one FDA Regulatory Exclusivity.
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 | 215390-002 | Apr 5, 2022 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Bioxcel | IGALMI | dexmedetomidine hydrochloride | FILM;BUCCAL, SUBLINGUAL | 215390-001 | Apr 5, 2022 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Bioxcel | IGALMI | dexmedetomidine hydrochloride | FILM;BUCCAL, SUBLINGUAL | 215390-002 | Apr 5, 2022 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Bioxcel | IGALMI | dexmedetomidine hydrochloride | FILM;BUCCAL, SUBLINGUAL | 215390-002 | Apr 5, 2022 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Bioxcel | IGALMI | dexmedetomidine hydrochloride | FILM;BUCCAL, SUBLINGUAL | 215390-001 | Apr 5, 2022 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Bioxcel | IGALMI | dexmedetomidine hydrochloride | FILM;BUCCAL, SUBLINGUAL | 215390-001 | Apr 5, 2022 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Bioxcel | IGALMI | dexmedetomidine hydrochloride | FILM;BUCCAL, SUBLINGUAL | 215390-001 | Apr 5, 2022 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
>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 | 114096880 | LIDAR系统中的波长选择 (WAVELENGTH SELECTION IN LIDAR SYSTEMS) | ⤷ Subscribe |
Mexico | 2019007923 | USO DE DEXMEDETOMIDINA SUBLINGUAL PARA EL TRATAMIENTO DE LA AGITACION. (USE OF SUBLINGUAL DEXMEDETOMIDINE FOR THE TREATMENT OF AGITATION.) | ⤷ Subscribe |
Mexico | 2022000709 | ⤷ Subscribe | |
Singapore | 10202107367S | USE OF SUBLINGUAL DEXMEDETOMIDINE FOR THE TREATMENT OF AGITATION | ⤷ Subscribe |
Canada | 3145388 | ⤷ Subscribe | |
Japan | 2021529756 | デクスメデトミジンを含むフィルム製剤、及びその作製方法 | ⤷ Subscribe |
Japan | 2022540706 | ⤷ Subscribe | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for IGALMI
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0300652 | 2003C/005 | Belgium | ⤷ Subscribe | PRODUCT NAME: CHLORHYDRATE DE DEXMEDETOMIDINE; REGISTRATION NO/DATE: EU/2/02/033/001 20020903 |
0300652 | C300117 | Netherlands | ⤷ Subscribe | 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 |
IGALMI Market Analysis and Financial Projection Experimental
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