Is BioXcel Therapeutics, Inc. FDA approved?

BioXcel Therapeutics, Inc. holds no registered establishment of its own; 2 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does BioXcel Therapeutics, Inc. make?

2 products are listed under BioXcel Therapeutics, Inc. in the openFDA NDC Directory, most often as film. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

BioXcel Therapeutics, Inc.

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 0
Active NDC listings: 2
Live patents: 28
Exclusivities: 1
Countries: 0

Catalogue

Drug listings by form and route

2 active NDC listings: 2 human prescription drug. By marketing category: NDA 2.

Dosage form	NDCs
film	2

Route	NDCs
sublingual	2

Labeller name on the listing	NDCs
bioxcel therapeutics, inc.	2

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
11786508	IGALMIdexmedetomidine hydrochloride	use	Dec 2037
11839604	IGALMIdexmedetomidine hydrochloride	use	Dec 2037
10792246	IGALMIdexmedetomidine hydrochloride	product	Jun 2039
11478422	IGALMIdexmedetomidine hydrochloride	product	Jun 2039
11497711	IGALMIdexmedetomidine hydrochloride	product	Jun 2039
11517524	IGALMIdexmedetomidine hydrochloride	product	Jun 2039
11890272	IGALMIdexmedetomidine hydrochloride	use	Jul 2040
11998529	IGALMIdexmedetomidine hydrochloride	use	Jul 2040
12109196	IGALMIdexmedetomidine hydrochloride	use	Jul 2040
11806334	IGALMIdexmedetomidine hydrochloride	use	Jan 2043
11998528	IGALMIdexmedetomidine hydrochloride	use	Jan 2043
12090140	IGALMIdexmedetomidine hydrochloride	use	Jan 2043
12138247	IGALMIdexmedetomidine hydrochloride	use	Jan 2043
12364683	IGALMIdexmedetomidine hydrochloride	use	Jan 2043

Product	Exclusivity	Until
IGALMIDEXMEDETOMIDINE HYDROCHLORIDE	M-82 Miscellaneous	Nov 2028

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
IGALMI	DEXMEDETOMIDINE	film, sublingual	81092-1120NDA
IGALMI	DEXMEDETOMIDINE	film, sublingual	81092-1180NDA

Compare

Other companies listing dexmedetomidine

ProPharma Distribution, LLC.3 sites · 100 NDC
Hubei Biocause Heilen Pharmaceutical Co., Ltd2 sites · 10 NDC
Meitheal Pharmaceuticals, Inc.0 sites · 171 NDC

Enquiry

Common questions

Is BioXcel Therapeutics, Inc. FDA approved?: BioXcel Therapeutics, Inc. holds no registered establishment of its own; 2 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does BioXcel Therapeutics, Inc. make?: 2 products are listed under BioXcel Therapeutics, Inc. in the openFDA NDC Directory, most often as film. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.