Is there a generic for Remifentanil hydrochloride?

Yes. The FDA Orange Book lists 3 approved generic (ANDA) applications for Remifentanil hydrochloride, referencing the brand ULTIVA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Remifentanil hydrochloride?

ULTIVA (NDA 020630, MYLAN INSTITUTIONAL) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Remifentanil hydrochloride are approved?

Remifentanil hydrochloride is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Remifentanil hydrochloride

Remifentanil hydrochloride is approved as 1 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ULTIVA · NDA 020630

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
ULTIVARLD×3	MYLAN INSTITUTIONAL	NDA 020630	AP	Jul 12, 1996

Generic (ANDA) products (3)

Product	Applicant	Application	TE	Approved
REMIFENTANIL HYDROCHLORIDE×3	NIVAGEN PHARMS INC	ANDA 215635	AP	Jun 28, 2024
REMIFENTANIL HYDROCHLORIDE×3	HIKMA	ANDA 210594	AP	Oct 13, 2020
REMIFENTANIL HYDROCHLORIDE×3	FRESENIUS KABI USA	ANDA 206223	AP	Jan 16, 2018

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Remifentanil hydrochloride — frequently asked questions

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

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