REMIFENTANIL HYDROCHLORIDE Drug Patent Profile

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

Remifentanil Hydrochloride is a drug marketed by Fresenius Kabi Usa and Hikma and is included in two NDAs.

The generic ingredient in REMIFENTANIL HYDROCHLORIDE is remifentanil hydrochloride. There are four drug master file entries for this compound. Three 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 16^th, 2018.

Summary for REMIFENTANIL HYDROCHLORIDE

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	27
Clinical Trials:	710
Patent Applications:	324
Formulation / Manufacturing:	see details
DailyMed Link:	REMIFENTANIL HYDROCHLORIDE at DailyMed

Recent Clinical Trials for REMIFENTANIL HYDROCHLORIDE

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

Sponsor	Phase
National University of Malaysia	N/A
Xiaobo Yang, MD	Phase 2
Wonkwang University Hospital	N/A

See all REMIFENTANIL HYDROCHLORIDE clinical trials

Pharmacology for REMIFENTANIL HYDROCHLORIDE

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

Anatomical Therapeutic Chemical (ATC) Classes for REMIFENTANIL HYDROCHLORIDE

N01AH	Opioid anesthetics
N01A	ANESTHETICS, GENERAL
N01	ANESTHETICS
N	Nervous system

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
Hikma	REMIFENTANIL HYDROCHLORIDE	remifentanil hydrochloride	INJECTABLE;INJECTION	210594-001	Oct 13, 2020	AP	RX	No	No
Fresenius Kabi Usa	REMIFENTANIL HYDROCHLORIDE	remifentanil hydrochloride	INJECTABLE;INJECTION	206223-002	Jan 16, 2018	AP	RX	No	No
Fresenius Kabi Usa	REMIFENTANIL HYDROCHLORIDE	remifentanil hydrochloride	INJECTABLE;INJECTION	206223-003	Jan 16, 2018	AP	RX	No	No
Hikma	REMIFENTANIL HYDROCHLORIDE	remifentanil hydrochloride	INJECTABLE;INJECTION	210594-003	Oct 13, 2020	AP	RX	No	No
Hikma	REMIFENTANIL HYDROCHLORIDE	remifentanil hydrochloride	INJECTABLE;INJECTION	210594-002	Oct 13, 2020	AP	RX	No	No