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Last Updated: April 18, 2024

REMIFENTANIL HYDROCHLORIDE - Generic Drug Details

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What are the generic sources for remifentanil hydrochloride and what is the scope of patent protection?

Remifentanil hydrochloride is the generic ingredient in two branded drugs marketed by Fresenius Kabi Usa, Hikma, and Mylan Institutional, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for remifentanil hydrochloride. Three suppliers are listed for this compound.

Summary for REMIFENTANIL HYDROCHLORIDE

US Patents:	0
Tradenames:	2
Applicants:	3
NDAs:	3
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	27
Clinical Trials:	710
Patent Applications:	492
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in REMIFENTANIL HYDROCHLORIDE?	REMIFENTANIL HYDROCHLORIDE excipients list
DailyMed Link:	REMIFENTANIL HYDROCHLORIDE at DailyMed

Recent Clinical Trials for REMIFENTANIL HYDROCHLORIDE

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

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

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan Institutional	ULTIVA	remifentanil hydrochloride	INJECTABLE;INJECTION	020630-002	Jul 12, 1996	AP	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Fresenius Kabi Usa	REMIFENTANIL HYDROCHLORIDE	remifentanil hydrochloride	INJECTABLE;INJECTION	206223-001	Jan 16, 2018	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mylan Institutional	ULTIVA	remifentanil hydrochloride	INJECTABLE;INJECTION	020630-001	Jul 12, 1996	AP	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mylan Institutional	ULTIVA	remifentanil hydrochloride	INJECTABLE;INJECTION	020630-003	Jul 12, 1996	AP	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for REMIFENTANIL HYDROCHLORIDE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mylan Institutional	ULTIVA	remifentanil hydrochloride	INJECTABLE;INJECTION	020630-001	Jul 12, 1996	⤷ Try a Trial	⤷ Try a Trial
Mylan Institutional	ULTIVA	remifentanil hydrochloride	INJECTABLE;INJECTION	020630-002	Jul 12, 1996	⤷ Try a Trial	⤷ Try a Trial
Mylan Institutional	ULTIVA	remifentanil hydrochloride	INJECTABLE;INJECTION	020630-002	Jul 12, 1996	⤷ Try a Trial	⤷ Try a Trial
Mylan Institutional	ULTIVA	remifentanil hydrochloride	INJECTABLE;INJECTION	020630-001	Jul 12, 1996	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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