Is there a generic for Rocuronium bromide?

Yes. The FDA Orange Book lists 21 approved generic (ANDA) applications for Rocuronium bromide, referencing the brand ROCURONIUM BROMIDE. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Rocuronium bromide?

ROCURONIUM BROMIDE (NDA 219108, B BRAUN MEDICAL) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Rocuronium bromide?

The Orange Book lists 1 patent against Rocuronium bromide products, with the earliest listed expiry in 2039. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Rocuronium bromide are approved?

Rocuronium bromide is approved in the following dosage forms: injectable, solution.

FDA Orange Book · active-ingredient family

Rocuronium bromide

Rocuronium bromide is approved as 3 brand and 21 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ROCURONIUM BROMIDE · NDA 219108

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable, solution

Product	Applicant	Application	TE	Approved
ROCURONIUM BROMIDERLD	B BRAUN MEDICAL	NDA 219108	—	Oct 24, 2025
ROCURONIUM BROMIDERLD×2	FRESENIUS KABI USA	NDA 217472	—	Jun 09, 2025
ZEMURONRLD×3	ORGANON USA INC	NDA 020214	—	Mar 17, 1994

Generic (ANDA) products (21)

Product	Applicant	Application	TE	Approved
ROCURONIUM BROMIDE×2	ASPIRO	ANDA 220124	AP	Mar 04, 2026
ROCURONIUM BROMIDE×2	KNACK	ANDA 213476	—	Jan 06, 2026
ROCURONIUM BROMIDE×2	MANKIND PHARMA	ANDA 219674	AP	May 29, 2025
ROCURONIUM BROMIDE	STERISCIENCE	ANDA 217092	AP	Jul 22, 2024
ROCURONIUM BROMIDE×2	RISING	ANDA 204918	—	Jul 12, 2024
ROCURONIUM BROMIDE×2	SHANDONG	ANDA 215684	AP	Jul 12, 2024
ROCURONIUM BROMIDE	HIKMA	ANDA 217034	—	May 24, 2023
ROCURONIUM BROMIDE×2	MEITHEAL	ANDA 213453	AP	May 08, 2023
ROCURONIUM BROMIDE×2	CAPLIN	ANDA 216234	AP	Mar 02, 2023
ROCURONIUM BROMIDE×2	PRINSTON INC	ANDA 212668	AP	May 26, 2022
ROCURONIUM BROMIDE×2	PIRAMAL CRITICAL	ANDA 210437	AP	Aug 13, 2019
ROCURONIUM BROMIDE×2	GLAND	ANDA 205656	AP	Apr 04, 2018
ROCURONIUM BROMIDE×2	EUGIA PHARMA	ANDA 206206	AP	Apr 12, 2017
ROCURONIUM BROMIDE×2	WEST WARD PHARM CORP	ANDA 204679	AP	Feb 28, 2017
ROCURONIUM BROMIDE×2	TAMARANG	ANDA 091115	AP	Aug 27, 2012
ROCURONIUM BROMIDE×2	SAGENT PHARMS INC	ANDA 091458	AP	Jul 28, 2010
ROCURONIUM BROMIDE×2	FRESENIUS KABI USA	ANDA 078651	AP	Dec 29, 2008
ROCURONIUM BROMIDE×2	SANDOZ	ANDA 079195	AP	Dec 05, 2008
ROCURONIUM BROMIDE×2	HOSPIRA	ANDA 078519	AP	Nov 26, 2008
ROCURONIUM BROMIDE×2	MYLAN INSTITUTIONAL	ANDA 079199	AP	Nov 26, 2008
ROCURONIUM BROMIDE×2	TEVA PHARMS	ANDA 078717	—	Nov 26, 2008

Listed patents (1)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
11998605	Jul 22, 2039	in 13 yr 3 mo	Product

Rocuronium bromide — frequently asked questions

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

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