IGALMI Drug Patent Profile
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Which patents cover Igalmi, 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 18th, 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 |
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 twelve US patents and one FDA Regulatory Exclusivity.
Patents protecting IGALMI
Film formulations containing dexmedetomidine and methods of producing them
Patent Number: ⤷ Sign Up
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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
Film formulations containing dexmedetomidine and methods of producing them
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: ACUTE TREATMENT OF AGITATION ASSOCIATED WITH SCHIZOPHRENIA OR BIPOLAR I OR II DISORDER BY BUCCAL ADMINISTRATION
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Patent Expiration: ⤷ Sign Up
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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Patent Expiration: ⤷ Sign Up
Patented Use: ACUTE TREATMENT OF AGITATION ASSOCIATED WITH SCHIZOPHRENIA OR BIPOLAR I OR II DISORDER BY SUBLINGUAL OR BUCCAL ADMINISTRATION
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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: ACUTE TREATMENT OF AGITATION ASSOCIATED WITH SCHIZOPHRENIA OR BIPOLAR I OR II DISORDER BY SUBLINGUAL OR BUCCAL ADMINISTRATION
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: ACUTE TREATMENT OF AGITATION ASSOCIATED WITH SCHIZOPHRENIA OR BIPOLAR I OR II DISORDER BY SUBLINGUAL OR BUCCAL ADMINISTRATION
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Patent Expiration: ⤷ Sign Up
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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Exclusivity Expiration: ⤷ Sign Up
| 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 | ||||
| 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 | 215390-002 | Apr 5, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| South Korea | 20220049526 | 비-진정성 덱스메데토미딘 치료 양생법 | ⤷ Sign Up |
| China | 110337290 | 舌下右旋美托咪啶用于治疗激越的用途 (Use of sublingual dexmedetomidine for treatment of agitation) | ⤷ Sign Up |
| Mexico | 2023000213 | USO DE DEXMEDETOMIDINA SUBLINGUAL PARA EL TRATAMIENTO DE LA AGITACION. (USE OF SUBLINGUAL DEXMEDETOMIDINE FOR THE TREATMENT OF AGITATION.) | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2021016112 | ⤷ Sign Up | |
| Eurasian Patent Organization | 201991361 | ПРИМЕНЕНИЕ СУБЛИНГВАЛЬНОГО ДЕКСМЕДЕТОМИДИНА ДЛЯ ЛЕЧЕНИЯ АЖИТАЦИИ | ⤷ Sign Up |
| 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 | ⤷ Sign Up |
| Mexico | 2020014000 | FORMULACIONES EN LÁMINA QUE CONTIENEN DEXMEDETOMIDINA Y MÉTODOS PARA PRODUCIRLAS. (FILM FORMULATIONS CONTAINING DEXMEDETOMIDINE AND METHODS OF PRODUCING THEM.) | ⤷ Sign Up |
| >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 | ⤷ 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 |
| 0300652 | 2003C/005 | Belgium | ⤷ Sign Up | 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 |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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