Generic Igalmi Availability
Last updated on Apr 10, 2024.
Igalmi is a brand name of dexmedetomidine, approved by the FDA in the following formulation(s):
IGALMI (dexmedetomidine hydrochloride - film;buccal, sublingual)
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Manufacturer: BIOXCEL
Approval date: April 5, 2022
Strength(s): EQ 0.12MG BASE [RLD], EQ 0.18MG BASE [RLD]
Has a generic version of Igalmi been approved?
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.
See also: Generic Drug FAQ.
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.
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Film formulations containing dexmedetomidine and methods of producing them
Patent 10,792,246
Issued: October 6, 2020
Inventor(s): Kakumanu Vasukumar & Hanley David Christian & Yocca Frank & Lathia Chetan Dalpatbhai & Barnhart Scott DavidDisclosed 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✓✓
- June 26, 2039
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Patent 11,478,422
Patent expiration dates:
- June 26, 2039✓
- June 26, 2039
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Patent 11,497,711
Patent expiration dates:
- June 26, 2039✓✓
- June 26, 2039
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Film formulations containing dexmedetomidine and methods of producing them
Patent 11,517,524
Issued: December 6, 2022
Inventor(s): Kakumanu Vasukumar & Hanley David Christian & Yocca Frank & Lathia Chetan Dalpatbhai & Barnhart Scott DavidDisclosed 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✓✓
- June 26, 2039
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Patent 11,786,508
Patent expiration dates:
- December 29, 2037✓
- December 29, 2037
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Patent 11,806,334
Patent expiration dates:
- January 12, 2043✓
- January 12, 2043
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Patent 11,839,604
Patent expiration dates:
- December 29, 2037✓
- December 29, 2037
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Patent 11,890,272
Patent expiration dates:
- July 17, 2040✓
- July 17, 2040
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)
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- Drug class: miscellaneous anxiolytics, sedatives and hypnotics
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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.