Igalmi is a drug owned by Bioxcel Therapeutics Inc. It is protected by 14 US drug patents filed from 2022 to 2025 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 12, 2043. Details of Igalmi's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US12138247 | Non-sedating dexmedetomidine treatment regimens |
Jan, 2043
(17 years from now) | Active |
| US12090140 | Non-sedating dexmedetomidine treatment regimens |
Jan, 2043
(17 years from now) | Active |
| US12364683 | NA |
Jan, 2043
(17 years from now) | Active |
| US11806334 | Non-sedating dexmedetomidine treatment regimens |
Jan, 2043
(17 years from now) | Active |
| US11998528 | Non-sedating dexmedetomidine treatment regimens |
Jan, 2043
(17 years from now) | Active |
| US11890272 | Non-sedating dexmedetomidine treatment regimens |
Jul, 2040
(14 years from now) | Active |
| US11998529 | Non-sedating dexmedetomidine treatment regimens |
Jul, 2040
(14 years from now) | Active |
| US12109196 | Non-sedating dexmedetomidine treatment regimens |
Jul, 2040
(14 years from now) | Active |
| US11478422 | Film formulations containing dexmedetomidine and methods of producing them |
Jun, 2039
(13 years from now) | Active |
| US10792246 | Film formulations containing dexmedetomidine and methods of producing them |
Jun, 2039
(13 years from now) | Active |
| US11517524 | Film formulations containing dexmedetomidine and methods of producing them |
Jun, 2039
(13 years from now) | Active |
| US11497711 | Film formulations containing dexmedetomidine and methods of producing them |
Jun, 2039
(13 years from now) | Active |
| US11786508 | Use of sublingual dexmedetomidine for the treatment of agitation |
Dec, 2037
(12 years from now) | Active |
| US11839604 | Use of sublingual dexmedetomidine for the treatment of agitation |
Dec, 2037
(12 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical
activities like
abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease
the life of a
patent hence affecting its expiry date and in turn affecting the generic launch date of that drug.
Tracking these
ongoing activities on a patent application helps to keep an eye on the latest developments in the
patent process of
the drug which can give an idea of how early a drug's generic could be available. The next section
provides a list of
recent legal activities on Igalmi's patents.
Latest Legal Activities on Igalmi's Patents
Given below is the list of recent legal activities going on the following patents of Igalmi.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Email Notification
Critical | 24 Apr, 2024 | US11890272 |
| Patent eCofC Notification | 23 Apr, 2024 | US11890272 |
| Email Notification
Critical | 23 Apr, 2024 | US10792246 |
| Recordation of Patent eCertificate of Correction | 23 Apr, 2024 | US11890272 |
| Mail Patent eCofC Notification | 23 Apr, 2024 | US11890272 |
| Patent eCofC Notification | 23 Apr, 2024 | US10792246 |
| Email Notification
Critical | 23 Apr, 2024 | US11890272 |
| Mail Patent eCofC Notification | 23 Apr, 2024 | US10792246 |
| Recordation of Patent eCertificate of Correction | 23 Apr, 2024 | US10792246 |
| Post Issue Communication - Certificate of Correction | 04 Apr, 2024 | US11890272 |
FDA has granted several exclusivities to Igalmi. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Igalmi, regardless of the status of it's patents. These exclusivities hence play a crucial role in
delaying the generic
launch. Given below are details of the exclusivities granted to
Igalmi.
Exclusivity Information
Igalmi holds 1 exclusivities. All of its exclusivities have expired in 2025. Details of Igalmi's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Apr 05, 2025 |
US patents provide insights into the exclusivity only within the United States, but
Igalmi is protected by patents in multiple countries.
Understanding
the full scope
of patent protection is crucial in strategizing market entry. By looking at the broader patent
landscape, you can
identify markets with weaker patent protection which could be ideal generic entry points. The
following section offers
details on Igalmi's family patents as well as insights into
ongoing legal events
on those patents.
Igalmi's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Igalmi's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 12, 2043 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Igalmi Generic API suppliers:
Dexmedetomidine Hydrochloride is the generic name for the brand Igalmi. 24 different companies have already filed for the generic of Igalmi, with Hikma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Igalmi's generic
Alternative Brands for Igalmi
Igalmi which is used for treating agitation associated with bipolar disorder or schizophrenia with sublingual or buccal administration., has several other brand drugs using the same active ingredient (Dexmedetomidine Hydrochloride). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | |
|---|---|---|
| Hospira |
| |
| Hq Spclt Pharma |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Dexmedetomidine Hydrochloride, Igalmi's active ingredient. Check the complete list of approved generic manufacturers for Igalmi
About Igalmi
Igalmi is a drug owned by Bioxcel Therapeutics Inc. It is used for treating agitation associated with bipolar disorder or schizophrenia with sublingual or buccal administration. Igalmi uses Dexmedetomidine Hydrochloride as an active ingredient. Igalmi was launched by Bioxcel in 2022.
Approval Date:
Igalmi was approved by FDA for market use on 05 April, 2022.
Active Ingredient:
Igalmi uses Dexmedetomidine Hydrochloride as the active ingredient. Check out other Drugs and Companies using Dexmedetomidine Hydrochloride ingredient
Treatment:
Igalmi is used for treating agitation associated with bipolar disorder or schizophrenia with sublingual or buccal administration.
Dosage:
Igalmi is available in film form for buccal, sublingual use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 0.18MG BASE | FILM | Prescription | BUCCAL, SUBLINGUAL |
| EQ 0.12MG BASE | FILM | Prescription | BUCCAL, SUBLINGUAL |