Last Updated: July 1, 2026

DEXMEDETOMIDINE Drug Patent Profile


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Which patents cover Dexmedetomidine, and what generic alternatives are available?

Dexmedetomidine is a drug marketed by Accord Hlthcare, Actavis Inc, Am Regent, Amneal, Amneal Pharms Co, Baxter Hlthcare Corp, Caplin, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Gland, Hengrui Pharma, Hikma, Knack, Meitheal, Milla Pharms, Mylan Institutional, Mylan Labs Ltd, Ph Health, Piramal Critical, Rising, Tagi, Teva Pharms Usa, Wilshire Pharms Inc, Zydus Pharms, Hq Spclt Pharma, and Somerset. and is included in thirty-three NDAs. There are two patents protecting this drug.

The generic ingredient in DEXMEDETOMIDINE is dexmedetomidine hydrochloride. There are fourteen drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the dexmedetomidine hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Dexmedetomidine

A generic version of DEXMEDETOMIDINE was approved as dexmedetomidine hydrochloride by MYLAN INSTITUTIONAL on August 18th, 2014.

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Summary for DEXMEDETOMIDINE
US Patents:0
Applicants:27
NDAs:33
Drug Prices: Drug price information for DEXMEDETOMIDINE
What excipients (inactive ingredients) are in DEXMEDETOMIDINE?DEXMEDETOMIDINE excipients list
DailyMed Link:DEXMEDETOMIDINE at DailyMed
Recent Clinical Trials for DEXMEDETOMIDINE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Istinye UniversityNA
University of Missouri-ColumbiaPHASE4
Sun FeiNA

See all DEXMEDETOMIDINE clinical trials

US Patents and Regulatory Information for DEXMEDETOMIDINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ph Health DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride INJECTABLE;INJECTION 208266-002 Sep 15, 2020 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Knack DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride INJECTABLE;INJECTION 218675-001 Mar 9, 2026 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Wilshire Pharms Inc DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride INJECTABLE;INJECTION 212791-001 Dec 4, 2019 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Tagi DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride INJECTABLE;INJECTION 212857-002 Nov 23, 2020 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Wilshire Pharms Inc DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride INJECTABLE;INJECTION 212791-002 Dec 4, 2019 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Hq Spclt Pharma DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride SOLUTION;INTRAVENOUS 206628-001 Oct 21, 2015 AP RX Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Hikma DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride INJECTABLE;INJECTION 206407-003 May 30, 2025 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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