OpenRx Open Medications Explorer
© 2026 OpenRx · public-domain U.S. government data
On this page

IGALMI

Dexmedetomidine · Film

Prescription NDA RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
IGALMI
Generic name
Dexmedetomidine
Dosage form
Film
Route
Sublingual
Marketing category
NDA · NDA
Labeler
BioXcel Therapeutics, Inc.
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
2
Packages
4
Data completeness
54% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Dexmedetomidine 120 ug/1 — —
Dexmedetomidine 180 ug/1 — —

Forms, strengths and routes

Source: NDC Directory
Dosage form
Film
Route of administration
Sublingual
Presentations
6

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Adrenergic alpha2-Agonists [MoA] MoA All 44 members
Central alpha-2 Adrenergic Agonist [EPC] EPC All 44 members
General Anesthesia [PE] PE All 29 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
215390
Application type
NDA · New Drug Application
Approval date
April 5, 2022
Sponsor
BIOXCEL
Products on application
2
Submissions recorded
3
Products approved under application 215390.
Product Trade name Form Strength Ingredient Status TE Flags
215390-001 IGALMI FILM DEXMEDETOMIDINE HYDROCHLORIDE Prescription — RLD RS
215390-002 IGALMI FILM DEXMEDETOMIDINE HYDROCHLORIDE Prescription — RLD

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book
Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent Expires Product Substance Use code Submitted
11786508 December 29, 2037 001 No U-3698 October 17, 2023
11839604 December 29, 2037 001 No U-3756 December 12, 2023
11786508 December 29, 2037 002 No U-3698 October 17, 2023
11839604 December 29, 2037 002 No U-3756 December 12, 2023
10792246 June 26, 2039 001 No U-3350 April 28, 2022
11517524 June 26, 2039 001 No U-3645 December 6, 2022
11497711 June 26, 2039 001 No U-3645 November 15, 2022
11478422 June 26, 2039 001 No November 22, 2022
10792246 June 26, 2039 002 No U-3350 April 28, 2022
11517524 June 26, 2039 002 No U-3645 December 6, 2022
11497711 June 26, 2039 002 No U-3645 November 15, 2022
11478422 June 26, 2039 002 No November 22, 2022
11998529 July 17, 2040 001 No U-3935 June 5, 2024
12109196 July 17, 2040 001 No U-3935 October 11, 2024
11890272 July 17, 2040 001 No U-3935 February 6, 2024
11890272 July 17, 2040 001 No U-3756 February 6, 2024
11998529 July 17, 2040 002 No U-3935 June 5, 2024
12109196 July 17, 2040 002 No U-3935 October 11, 2024
11890272 July 17, 2040 002 No U-3935 February 6, 2024
11890272 July 17, 2040 002 No U-3756 February 6, 2024
12364683 January 12, 2043 001 No U-4029 August 21, 2025
11998528 January 12, 2043 001 No U-3935 June 20, 2024
11806334 January 12, 2043 001 No U-3725 November 7, 2023
12090140 January 12, 2043 001 No U-3986 September 18, 2024
12138247 January 12, 2043 001 No U-4029 November 13, 2024
12364683 January 12, 2043 002 No U-4029 August 21, 2025
11998528 January 12, 2043 002 No U-3935 June 20, 2024
11806334 January 12, 2043 002 No U-3725 November 7, 2023
12090140 January 12, 2043 002 No U-3986 September 18, 2024
12138247 January 12, 2043 002 No U-4029 November 13, 2024
Regulatory exclusivity periods.
Code Expires Product
M-82 November 19, 2028 001
M-82 November 19, 2028 002

Approval history

Source: Drugs@FDA
Most recent submissions on application 215390.
Type No. Action Status Date Review
Supplement 2 Efficacy Approved November 19, 2025 Standard
Supplement 1 Labeling Approved October 24, 2022 Standard
Original application 1 Type 3 - New Dosage Form Approved April 5, 2022 Standard

Review documents

  • 0 · Supplement · November 21, 2025
  • 0 · Supplement · November 20, 2025
  • 0 · Original application · January 23, 2023
  • 0 · Original application · January 23, 2023
  • 0 · Supplement · October 25, 2022
  • 0 · Original application · April 11, 2022
  • 0 · Original application · April 6, 2022

Adverse event reports

Source: openFDA FAERS
6,295
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: DEXMEDETOMIDINE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
81092-1120-1 81092-1120 BioXcel Therapeutics, Inc. 10 POUCH in 1 CARTON (81092-1120-1) / 1 FILM in 1 POUCH (81092-1120-0) July 1, 2022
81092-1120-3 81092-1120 BioXcel Therapeutics, Inc. 30 POUCH in 1 CARTON (81092-1120-3) / 1 FILM in 1 POUCH (81092-1120-0) July 1, 2024
81092-1180-1 81092-1180 BioXcel Therapeutics, Inc. 10 POUCH in 1 CARTON (81092-1180-1) / 1 FILM in 1 POUCH (81092-1180-0) July 1, 2022
81092-1180-3 81092-1180 BioXcel Therapeutics, Inc. 30 POUCH in 1 CARTON (81092-1180-3) / 1 FILM in 1 POUCH (81092-1180-0) July 1, 2024
81092-1120 81092-1120 BioXcel Therapeutics, Inc. — July 1, 2022
81092-1180 81092-1180 BioXcel Therapeutics, Inc. — July 1, 2022

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.