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Last Updated: November 21, 2024

REMIFENTANIL HYDROCHLORIDE Drug Patent Profile


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Which patents cover Remifentanil Hydrochloride, and when can generic versions of Remifentanil Hydrochloride launch?

Remifentanil Hydrochloride is a drug marketed by Fresenius Kabi Usa, Hikma, and Nivagen Pharms Inc. and is included in three NDAs.

The generic ingredient in REMIFENTANIL HYDROCHLORIDE is remifentanil hydrochloride. There are four drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the remifentanil hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Remifentanil Hydrochloride

A generic version of REMIFENTANIL HYDROCHLORIDE was approved as remifentanil hydrochloride by FRESENIUS KABI USA on January 16th, 2018.

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Drug patent expirations by year for REMIFENTANIL HYDROCHLORIDE
Recent Clinical Trials for REMIFENTANIL HYDROCHLORIDE

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

SponsorPhase
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityN/A
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research HospitalN/A
Cedars-Sinai Medical CenterPhase 2

See all REMIFENTANIL HYDROCHLORIDE clinical trials

Pharmacology for REMIFENTANIL HYDROCHLORIDE
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Anatomical Therapeutic Chemical (ATC) Classes for REMIFENTANIL HYDROCHLORIDE
Paragraph IV (Patent) Challenges for REMIFENTANIL HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ULTIVA for Injection remifentanil hydrochloride 1 mg/vial, 2 mg/vial and 5 mg/vial 020630 1 2013-12-27

US Patents and Regulatory Information for REMIFENTANIL HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fresenius Kabi Usa REMIFENTANIL HYDROCHLORIDE remifentanil hydrochloride INJECTABLE;INJECTION 206223-001 Jan 16, 2018 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Nivagen Pharms Inc REMIFENTANIL HYDROCHLORIDE remifentanil hydrochloride INJECTABLE;INJECTION 215635-001 Jun 28, 2024 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hikma REMIFENTANIL HYDROCHLORIDE remifentanil hydrochloride INJECTABLE;INJECTION 210594-001 Oct 13, 2020 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Nivagen Pharms Inc REMIFENTANIL HYDROCHLORIDE remifentanil hydrochloride INJECTABLE;INJECTION 215635-002 Jun 28, 2024 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Fresenius Kabi Usa REMIFENTANIL HYDROCHLORIDE remifentanil hydrochloride INJECTABLE;INJECTION 206223-002 Jan 16, 2018 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Fresenius Kabi Usa REMIFENTANIL HYDROCHLORIDE remifentanil hydrochloride INJECTABLE;INJECTION 206223-003 Jan 16, 2018 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hikma REMIFENTANIL HYDROCHLORIDE remifentanil hydrochloride INJECTABLE;INJECTION 210594-003 Oct 13, 2020 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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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