Is there a generic for Dexmedetomidine hydrochloride?

Yes. The FDA Orange Book lists 32 approved generic (ANDA) applications for Dexmedetomidine hydrochloride, referencing the brand IGALMI. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Dexmedetomidine hydrochloride?

IGALMI (NDA 215390, BIOXCEL) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Dexmedetomidine hydrochloride?

The Orange Book lists 29 patents against Dexmedetomidine hydrochloride products, with the earliest listed expiry in 2032. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Does Dexmedetomidine hydrochloride have FDA marketing exclusivity?

Yes. The Orange Book records 2 marketing-exclusivity periods for Dexmedetomidine hydrochloride. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

What dosage forms of Dexmedetomidine hydrochloride are approved?

Dexmedetomidine hydrochloride is approved in the following dosage forms: film, injectable, solution.

FDA Orange Book · active-ingredient family

Dexmedetomidine hydrochloride

Dexmedetomidine hydrochloride is approved as 3 brand and 32 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:IGALMI · NDA 215390

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · film, injectable, solution

Product	Applicant	Application	TE	Approved
IGALMIRLD×2	BIOXCEL	NDA 215390	—	Apr 05, 2022
PRECEDEXRLD×5	HOSPIRA	NDA 021038	AP	Jan 31, 2020
DEXMEDETOMIDINE HYDROCHLORIDERLD×4	HQ SPCLT PHARMA	NDA 206628	AP	Oct 21, 2015

Generic (ANDA) products (32)

Product	Applicant	Application	TE	Approved
DEXMEDETOMIDINE HYDROCHLORIDE	BAXTER HLTHCARE CORP	ANDA 208103	AP	Apr 15, 2026
DEXMEDETOMIDINE HYDROCHLORIDE	KNACK	ANDA 218675	—	Mar 09, 2026
DEXMEDETOMIDINE HYDROCHLORIDE×2	DR REDDYS	ANDA 220315	AP	Feb 25, 2026
DEXMEDETOMIDINE HYDROCHLORIDE×3	HIKMA	ANDA 206407	AP	May 30, 2025
DEXMEDETOMIDINE HYDROCHLORIDE×2	SOMERSET	ANDA 218112	AP	Sep 24, 2024
DEXMEDETOMIDINE HYDROCHLORIDE×2	MILLA PHARMS	ANDA 217308	AP	Jun 07, 2023
DEXMEDETOMIDINE HYDROCHLORIDE×2	AMNEAL	ANDA 216604	AP	May 15, 2023
DEXMEDETOMIDINE HYDROCHLORIDE	PIRAMAL CRITICAL	ANDA 214794	—	Sep 03, 2021
DEXMEDETOMIDINE HYDROCHLORIDE×2	EUGIA PHARMA	ANDA 210321	AP	Dec 07, 2020
DEXMEDETOMIDINE HYDROCHLORIDE×3	TAGI	ANDA 212857	AP	Nov 23, 2020
DEXMEDETOMIDINE HYDROCHLORIDE×2	PH HEALTH	ANDA 208266	AP	Sep 15, 2020
DEXMEDETOMIDINE HYDROCHLORIDE×2	MYLAN LABS LTD	ANDA 212571	AP	Aug 27, 2020
DEXMEDETOMIDINE HYDROCHLORIDE×4	HENGRUI PHARMA	ANDA 209065	AP	Jun 12, 2020
DEXMEDETOMIDINE HYDROCHLORIDE×2	GLAND	ANDA 209307	AP	Jun 03, 2020
DEXMEDETOMIDINE HYDROCHLORIDE×2	AMNEAL PHARMS CO	ANDA 207551	AP	May 20, 2020
DEXMEDETOMIDINE HYDROCHLORIDE×3	WILSHIRE PHARMS INC	ANDA 212791	—	May 08, 2020
DEXMEDETOMIDINE HYDROCHLORIDE	MEITHEAL	ANDA 204843	AP	Jan 18, 2019
DEXMEDETOMIDINE HYDROCHLORIDE×3	FRESENIUS KABI USA	ANDA 208129	AP	Nov 29, 2018
DEXMEDETOMIDINE HYDROCHLORIDE×2	BAXTER HLTHCARE CORP	ANDA 208532	AP	Aug 21, 2018
DEXMEDETOMIDINE HYDROCHLORIDE	ZYDUS PHARMS	ANDA 206798	AP	Feb 27, 2018
DEXMEDETOMIDINE HYDROCHLORIDE	TEVA PHARMS USA	ANDA 205272	AP	Nov 28, 2017
DEXMEDETOMIDINE HYDROCHLORIDE	AM REGENT	ANDA 203773	—	May 12, 2017
DEXMEDETOMIDINE HYDROCHLORIDE	HIKMA	ANDA 205046	AP	Apr 26, 2017
DEXMEDETOMIDINE HYDROCHLORIDE	ACTAVIS INC	ANDA 204686	AP	Oct 17, 2016
DEXMEDETOMIDINE HYDROCHLORIDE	CAPLIN	ANDA 091465	—	Jun 14, 2016
DEXMEDETOMIDINE HYDROCHLORIDE	EUGIA PHARMA	ANDA 205867	AP	Mar 17, 2016
DEXMEDETOMIDINE HYDROCHLORIDE	ACCORD HLTHCARE	ANDA 204023	AP	Feb 09, 2016
DEXMEDETOMIDINE HYDROCHLORIDE	FRESENIUS KABI USA	ANDA 201072	AP	Sep 18, 2015
DEXMEDETOMIDINE HYDROCHLORIDE	GLAND	ANDA 202126	AP	Aug 20, 2015
DEXMEDETOMIDINE HYDROCHLORIDE	RISING	ANDA 202585	AP	Nov 24, 2014
DEXMEDETOMIDINE HYDROCHLORIDE	MYLAN INSTITUTIONAL	ANDA 202881	AP	Aug 18, 2014
DEXMEDETOMIDINE HYDROCHLORIDE	PH HEALTH	ANDA 203972	AP	Aug 18, 2014

Marketing exclusivity (2)

M-82New use / labeling-change exclusivity (3 years)
Nov 19, 2028
in 2 yr 5 mo
M-82New use / labeling-change exclusivity (3 years)
Nov 19, 2028
in 2 yr 5 mo

Listed patents (29)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8455527	Jan 04, 2032	in 5 yr 8 mo	U-421
9616049	Jan 04, 2032	in 5 yr 8 mo	Product
8242158	Jan 04, 2032	in 5 yr 8 mo	Product
8338470	Jan 04, 2032	in 5 yr 8 mo	Product
9320712	Jan 04, 2032	in 5 yr 8 mo	Product
8648106	Jan 04, 2032	in 5 yr 8 mo	Product
10016396	Jan 04, 2032	in 5 yr 8 mo	Product
8648106*PED	Jul 04, 2032	in 6 yr 2 mo
8242158*PED	Jul 04, 2032	in 6 yr 2 mo
8455527*PED	Jul 04, 2032	in 6 yr 2 mo
8338470*PED	Jul 04, 2032	in 6 yr 2 mo
9320712*PED	Jul 04, 2032	in 6 yr 2 mo
9616049*PED	Jul 04, 2032	in 6 yr 2 mo
9717796	Apr 20, 2036	in 10 yr	Product
9649296	Apr 20, 2036	in 10 yr	Product
11786508	Dec 29, 2037	in 11 yr 8 mo	U-3698
11839604	Dec 29, 2037	in 11 yr 8 mo	U-3756
10792246	Jun 26, 2039	in 13 yr 3 mo	ProductU-3350
11517524	Jun 26, 2039	in 13 yr 3 mo	ProductU-3645
11497711	Jun 26, 2039	in 13 yr 3 mo	ProductU-3645
11478422	Jun 26, 2039	in 13 yr 3 mo	Product
11998529	Jul 17, 2040	in 14 yr 3 mo	U-3935
12109196	Jul 17, 2040	in 14 yr 3 mo	U-3935
11890272	Jul 17, 2040	in 14 yr 3 mo	U-3935
12364683	Jan 12, 2043	in 16 yr 10 mo	U-4029
11998528	Jan 12, 2043	in 16 yr 10 mo	U-3935
11806334	Jan 12, 2043	in 16 yr 10 mo	U-3725
12090140	Jan 12, 2043	in 16 yr 10 mo	U-3986
12138247	Jan 12, 2043	in 16 yr 10 mo	U-4029

Dexmedetomidine hydrochloride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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