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Last Updated: June 20, 2021

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ROCURONIUM BROMIDE - Generic Drug Details

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What are the generic sources for rocuronium bromide and what is the scope of patent protection?

Rocuronium bromide is the generic ingredient in two branded drugs marketed by Aurobindo Pharma Ltd, Fresenius Kabi Usa, Gland Pharma Ltd, Hospira, Mylan Institutional, Piramal Critical, Sagent Pharms Inc, Sandoz Inc, Tamarang, Teva Pharms, West Ward Pharm Corp, and Organon Usa Inc, and is included in twelve NDAs. Additional information is available in the individual branded drug profile pages.

There are eleven drug master file entries for rocuronium bromide. Fourteen suppliers are listed for this compound.

Summary for ROCURONIUM BROMIDE
Recent Clinical Trials for ROCURONIUM BROMIDE

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

SponsorPhase
Ankara City Hospital BilkentN/A
Clinical Hospital Centre ZagrebN/A
Ain Shams UniversityEarly Phase 1

See all ROCURONIUM BROMIDE clinical trials

Pharmacology for ROCURONIUM BROMIDE

US Patents and Regulatory Information for ROCURONIUM BROMIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gland Pharma Ltd ROCURONIUM BROMIDE rocuronium bromide INJECTABLE;INJECTION 205656-001 Apr 4, 2018 AP RX No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Mylan Institutional ROCURONIUM BROMIDE rocuronium bromide INJECTABLE;INJECTION 079199-001 Nov 26, 2008 AP RX No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Fresenius Kabi Usa ROCURONIUM BROMIDE rocuronium bromide INJECTABLE;INJECTION 078651-002 Dec 29, 2008 AP RX No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Sandoz Inc ROCURONIUM BROMIDE rocuronium bromide INJECTABLE;INJECTION 079195-002 Dec 5, 2008 AP RX No Yes   Try Before You Buy   Try Before You Buy   Try Before You Buy
Fresenius Kabi Usa ROCURONIUM BROMIDE rocuronium bromide INJECTABLE;INJECTION 078651-001 Dec 29, 2008 AP RX No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Aurobindo Pharma Ltd ROCURONIUM BROMIDE rocuronium bromide INJECTABLE;INJECTION 206206-002 Apr 12, 2017 AP RX No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Piramal Critical ROCURONIUM BROMIDE rocuronium bromide INJECTABLE;INJECTION 210437-002 Aug 13, 2019 AP RX No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
>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 ROCURONIUM BROMIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon Usa Inc ZEMURON rocuronium bromide INJECTABLE;INJECTION 020214-001 Mar 17, 1994   Try Before You Buy   Try Before You Buy
Organon Usa Inc ZEMURON rocuronium bromide INJECTABLE;INJECTION 020214-003 Mar 17, 1994   Try Before You Buy   Try Before You Buy
Organon Usa Inc ZEMURON rocuronium bromide INJECTABLE;INJECTION 020214-002 Mar 17, 1994   Try Before You Buy   Try Before You Buy
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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