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Last Updated: June 25, 2022

Rocuronium bromide - Generic Drug Details


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

Rocuronium bromide is the generic ingredient in two branded drugs marketed by Eugia Pharma, 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. Thirteen 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
Ain Shams UniversityEarly Phase 1
Clinical Hospital Centre ZagrebN/A

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
Sandoz Inc ROCURONIUM BROMIDE rocuronium bromide INJECTABLE;INJECTION 079195-002 Dec 5, 2008 AP RX No Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Tamarang ROCURONIUM BROMIDE rocuronium bromide INJECTABLE;INJECTION 091115-002 Aug 27, 2012 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Organon Usa Inc ZEMURON rocuronium bromide INJECTABLE;INJECTION 020214-001 Mar 17, 1994 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Piramal Critical ROCURONIUM BROMIDE rocuronium bromide INJECTABLE;INJECTION 210437-001 Aug 13, 2019 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan Institutional ROCURONIUM BROMIDE rocuronium bromide INJECTABLE;INJECTION 079199-001 Nov 26, 2008 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Organon Usa Inc ZEMURON rocuronium bromide INJECTABLE;INJECTION 020214-003 Mar 17, 1994 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Organon Usa Inc ZEMURON rocuronium bromide INJECTABLE;INJECTION 020214-003 Mar 17, 1994 See Plans and Pricing See Plans and Pricing
Organon Usa Inc ZEMURON rocuronium bromide INJECTABLE;INJECTION 020214-002 Mar 17, 1994 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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