Generic Igalmi Availability

Last updated on Apr 10, 2025.

Igalmi is a brand name of dexmedetomidine, approved by the FDA in the following formulation(s):

IGALMI (dexmedetomidine hydrochloride - film;buccal, sublingual)

Manufacturer: BIOXCEL
Approval date: April 5, 2022
Strength(s): EQ 0.12MG BASE ^[RLD], EQ 0.18MG BASE ^[RLD]

Is there a generic version of Igalmi available?

No. There is currently no therapeutically equivalent version of Igalmi available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Igalmi. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

Related patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

Film formulations containing dexmedetomidine and methods of producing them
Patent 10,792,246
Issued: October 6, 2020
Inventor(s): Kakumanu; Vasukumar et al.
Assignee(s): BIOXCEL THERAPEUTICS, INC. (New Haven, CT); ARX, LLC (Glen Rock, PA)
Disclosed herein is a self-supporting, dissolvable, film containing dexmedetomidine or a pharmaceutically acceptable salt thereof. The film is administered orally to treat various conditions, particularly agitation, by transmucosal delivery of the active agent.
Patent expiration dates:
- June 26, 2039
  ✓
  Patent use: ACUTE TREATMENT OF AGITATION ASSOCIATED WITH SCHIZOPHRENIA OR BIPOLAR I OR II DISORDER BY SUBLINGUAL ADMINISTRATION
  ✓
  Drug product
Film formulations containing dexmedetomidine and methods of producing them
Patent 11,478,422
Issued: October 25, 2022
Inventor(s): Kakumanu; Vasukumar et al.
Assignee(s): BioXcel Therapeutics, Inc. (New Haven, CT); ARx, LLC (Glen Rock, PA)
Disclosed herein is a self-supporting, dissolvable, film containing dexmedetomidine or a pharmaceutically acceptable salt thereof. The film is administered orally to treat various conditions, particularly agitation, by transmucosal delivery of the active agent.
Patent expiration dates:
- June 26, 2039
  ✓
  Drug product
Film formulations containing dexmedetomidine and methods of producing them
Patent 11,497,711
Issued: November 15, 2022
Inventor(s): Kakumanu; Vasukumar et al.
Assignee(s): BioXcel Therapeutics, Inc. (New Haven, CT); ARx, LLC (Glen Rock, PA)
Disclosed herein is a self-supporting, dissolvable, film containing dexmedetomidine or a pharmaceutically acceptable salt thereof. The film is administered orally to treat various conditions, particularly agitation, by transmucosal delivery of the active agent.
Patent expiration dates:
- June 26, 2039
  ✓
  Patent use: ACUTE TREATMENT OF AGITATION ASSOCIATED WITH SCHIZOPHRENIA OR BIPOLAR I OR II DISORDER BY BUCCAL ADMINISTRATION
  ✓
  Drug product
Film formulations containing dexmedetomidine and methods of producing them
Patent 11,517,524
Issued: December 6, 2022
Inventor(s): Kakumanu; Vasukumar et al.
Assignee(s): BioXcel Therapeutics, Inc. (New Haven, CT); ARx, LLC (Glen Rock, PA)
Disclosed herein is a self-supporting, dissolvable, film containing dexmedetomidine or a pharmaceutically acceptable salt thereof. The film is administered orally to treat various conditions, particularly agitation, by transmucosal delivery of the active agent.
Patent expiration dates:
- June 26, 2039
  ✓
  Patent use: ACUTE TREATMENT OF AGITATION ASSOCIATED WITH SCHIZOPHRENIA OR BIPOLAR I OR II DISORDER BY BUCCAL ADMINISTRATION
  ✓
  Drug product
Use of sublingual dexmedetomidine for the treatment of agitation
Patent 11,786,508
Issued: October 17, 2023
Inventor(s): Nandabalan; Krishnan et al.
Assignee(s): BioXcel Therapeutics, Inc. (New Haven, CT)
The present invention discloses a method of treating agitation or the signs of agitation in a subject comprising the sublingual administration of an effective amount of an alpha-2 adrenergic agonist, more particularly Dexmedetomidine, or a pharmaceutically acceptable salt thereof. The method is particularly suitable for the treatment of agitation associated with neurodegenerative and/or neuropsychiatric diseases. The present invention also discloses the sublingual administration of an alpha-2 adrenergic agonist, more particularly Dexmedetomidine or a pharmaceutically acceptable salt thereof at a dose that is effective to treat agitation or the signs of agitation in a subject, but does not cause significant sedation.
Patent expiration dates:
- December 29, 2037
  ✓
  Patent use: ACUTE TREATMENT OF AGITATION ASSOCIATED WITH SCHIZOPHRENIA BY SUBLINGUAL OR BUCCAL ADMINISTRATION
Non-sedating dexmedetomidine treatment regimens
Patent 11,806,334
Issued: November 7, 2023
Inventor(s): Kakumanu; Vasukumar et al.
Assignee(s): BioXcel Therapeutics, Inc. (New Haven, CT)
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.
Patent expiration dates:
- January 12, 2043
  ✓
  Patent 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
Use of sublingual dexmedetomidine for the treatment of agitation
Patent 11,839,604
Issued: December 12, 2023
Inventor(s): Nandabalan; Krishnan et al.
Assignee(s): Bioxcel Therapeutics, Inc. (New Haven, CT)
The present invention discloses a method of treating agitation or the signs of agitation in a subject comprising the sublingual administration of an effective amount of an alpha-2 adrenergic agonist, more particularly Dexmedetomidine, or a pharmaceutically acceptable salt thereof. The method is particularly suitable for the treatment of agitation associated with neurodegenerative and/or neuropsychiatric diseases. The present invention also discloses the sublingual administration of an alpha-2 adrenergic agonist, more particularly Dexmedetomidine or a pharmaceutically acceptable salt thereof at a dose that is effective to treat agitation or the signs of agitation in a subject, but does not cause significant sedation.
Patent expiration dates:
- December 29, 2037
  ✓
  Patent use: ACUTE TREATMENT OF AGITATION ASSOCIATED WITH BIPOLAR I OR II DISORDER BY SUBLINGUAL OR BUCCAL ADMINISTRATION
Non-sedating dexmedetomidine treatment regimens
Patent 11,890,272
Issued: February 6, 2024
Inventor(s): Kakumanu; Vasukumar et al.
Assignee(s): BioXcel Therapeutics, Inc. (New Haven, CT)
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.
Patent expiration dates:
- July 17, 2040
  ✓
  Patent use: ACUTE TREATMENT OF AGITATION ASSOCIATED WITH BIPOLAR I OR II DISORDER BY SUBLINGUAL OR BUCCAL ADMINISTRATION
- July 17, 2040
  ✓
  Patent use: ACUTE TREATMENT OF AGITATION ASSOCIATED WITH SCHIZOPHRENIA OR BIPOLAR I OR II DISORDER BY SUBLINGUAL OR BUCCAL ADMINISTRATION
Non-sedating dexmedetomidine treatment regimens
Patent 11,998,528
Issued: June 4, 2024
Inventor(s): Kakumanu; Vasukumar et al.
Assignee(s): BioXcel Therapeutics, Inc. (New Haven, CT)
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.
Patent expiration dates:
- January 12, 2043
  ✓
  Patent use: ACUTE TREATMENT OF AGITATION ASSOCIATED WITH SCHIZOPHRENIA OR BIPOLAR I OR II DISORDER BY SUBLINGUAL OR BUCCAL ADMINISTRATION
Non-sedating dexmedetomidine treatment regimens
Patent 11,998,529
Issued: June 4, 2024
Inventor(s): Kakumanu; Vasukumar et al.
Assignee(s): BioXcel Therapeutics, Inc. (New Haven, CT)
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.
Patent expiration dates:
- July 17, 2040
  ✓
  Patent use: ACUTE TREATMENT OF AGITATION ASSOCIATED WITH SCHIZOPHRENIA OR BIPOLAR I OR II DISORDER BY SUBLINGUAL OR BUCCAL ADMINISTRATION
Non-sedating dexmedetomidine treatment regimens
Patent 12,090,140
Issued: September 17, 2024
Inventor(s): Kakumanu; Vasukumar et al.
Assignee(s): BioXcel Therapeutics, Inc. (New Haven, CT)
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.
Patent expiration dates:
- January 12, 2043
  ✓
  Patent use: A METHOD OF TREATING AGITATION ASSOCIATED WITH SCHIZOPHRENIA OR BIPOLAR I OR II DISORDER
Non-sedating dexmedetomidine treatment regimens
Patent 12,109,196
Issued: October 8, 2024
Inventor(s): Kakumanu; Vasukumar et al.
Assignee(s): BioXcel Therapeutics, Inc. (New Haven, CT)
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.
Patent expiration dates:
- July 17, 2040
  ✓
  Patent use: ACUTE TREATMENT OF AGITATION ASSOCIATED WITH SCHIZOPHRENIA OR BIPOLAR I OR II DISORDER BY SUBLINGUAL OR BUCCAL ADMINISTRATION
Non-sedating dexmedetomidine treatment regimens
Patent 12,138,247
Issued: November 12, 2024
Inventor(s): Kakumanu; Vasukumar et al.
Assignee(s): BioXcel Therapeutics, Inc. (New Haven, CT)
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.
Patent expiration dates:
- January 12, 2043
  ✓
  Patent use: ACUTE TREATMENT OF AGITATION IN PATIENTS WITH SEVERE HEPATIC IMPAIRMENT

Related exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

Exclusivity expiration dates:
- April 5, 2025 - NEW PRODUCT

More about Igalmi (dexmedetomidine)

Patient resources

Igalmi buccal/sublingual drug information

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Professional resources

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Agitation

Glossary

Term	Definition
Drug Patent	A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug Exclusivity	Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLD	A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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Drug Status

Availability Prescription only Rx

Pregnancy & Lactation Risk data available

CSA Schedule* Not a controlled drug N/A

Approval History Drug history at FDA

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Pill medicine is Igalmi 120 mcg — Igalmi 120 mcg