Viewing data from:

ROCURONIUM BROMIDE

NDA

ROCURONIUM BROMIDE | N219108 | B BRAUN MEDICAL INC

1 strength1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)Today

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

Today

11998605

Jul. 22, 2039

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain14 active DMFs3 inactive

13 active API suppliers hold Drug Master Files for this ingredient.

ASPEN OSS BVROCURONIUM BROMIDE

DMF 98541992

WAVELENGTH ENTERPRISES LTDROCURONIUM BROMIDE

DMF 195722006

FARMHISPANIA SAROCURONIUM BROMIDE USP

DMF 198192006

TAPI NL BVROCURONIUM BROMIDE

DMF 200682006

GLAND PHARMA LTDROCURONIUM BROMIDE USP

DMF 208332007

GLAND CHEMICALS PRIVATE LTDROCURONIUM BROMIDE USP

DMF 264412012

ZHEJIANG XIANJU PHARMACEUTICAL CO LTDROCURONIUM BROMIDE USP NON-STERILE BULK DRUG SUBSTANCE

DMF 267652012

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDROCURONIUM BROMIDE USP

DMF 297412015

CHENGDU SINO-STRONG PHARMACEUTICAL CO LTDROCURONIUM BROMIDE

DMF 340572019

CURIA ITALY SRLROCURONIUM BROMIDE

DMF 342522019

SHANGHAI NEUTAN PHARMACEUTICAL CO LTDROCURONIUM BROMIDE INTERMEDIATE G (NEU1017-G)

DMF 366562022

SHANGHAI JUNMED HEALTHCARE CO LTDROCURONIUM BROMIDE (NEU1017-I)

DMF 376982023

MANKIND PHARMA LTDROCURONIUM BROMIDE USP

DMF 394372024

FARMHISPANIA SAROCURONIUM BROMIDE USP-PROCESS II

DMF 418942025

DR REDDYS LABORATORIES LTDInactiveROCURONIUM BROMIDE

DMF 208612007

RELIANCE LIFE SCIENCES PVT LTDInactiveROCURONIUM BROMIDE USP

DMF 251562011

AMRI ITALY SRLInactiveROCURONIUM BROMIDE

DMF 256222011

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Oct 28, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 50MG/5ML (10MG/ML)

RLD

1 patent0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Oct 24, 2025

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
11998605	Jul 22, 2039	—	—	Yes	—	—