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 Caplin, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, Meitheal, Mylan Institutional, Norvium Bioscience, Piramal Critical, Prinston Inc, Sagent Pharms Inc, Sandoz, Shandong, Steriscience, Tamarang, Teva Pharms, West Ward Pharm Corp, and Organon Usa Inc, and is included in nineteen NDAs. Additional information is available in the individual branded drug profile pages.

There are eleven drug master file entries for rocuronium bromide. Twenty-two suppliers are listed for this compound.

Summary for rocuronium bromide

US Patents:	0
Tradenames:	2
Applicants:	19
NDAs:	19
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	22
Raw Ingredient (Bulk) Api Vendors:	75
Clinical Trials:	57
Patent Applications:	826
What excipients (inactive ingredients) are in rocuronium bromide?	rocuronium bromide excipients list
DailyMed Link:	rocuronium bromide at DailyMed

Recent Clinical Trials for rocuronium bromide

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

Sponsor	Phase
Chosun University Hospital	N/A
Assiut University	Phase 2/Phase 3
Yangzhou University	N/A

See all rocuronium bromide clinical trials

Pharmacology for rocuronium bromide

Drug Class	Nondepolarizing Neuromuscular Blocker
Physiological Effect	Neuromuscular Nondepolarizing Blockade

Anatomical Therapeutic Chemical (ATC) Classes for rocuronium bromide

M03AC	Other quaternary ammonium compounds
M03A	MUSCLE RELAXANTS, PERIPHERALLY ACTING AGENTS
M03	MUSCLE RELAXANTS
M	Musculo-skeletal system

US Patents and Regulatory Information for rocuronium bromide

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hospira	ROCURONIUM BROMIDE	rocuronium bromide	INJECTABLE;INJECTION	078519-002	Nov 26, 2008	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Tamarang	ROCURONIUM BROMIDE	rocuronium bromide	INJECTABLE;INJECTION	091115-001	Aug 27, 2012	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Steriscience	ROCURONIUM BROMIDE	rocuronium bromide	INJECTABLE;INJECTION	217092-001	Jul 22, 2024	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

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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	⤷ Sign Up	⤷ Sign Up
Organon Usa Inc	ZEMURON	rocuronium bromide	INJECTABLE;INJECTION	020214-003	Mar 17, 1994	⤷ Sign Up	⤷ Sign Up
Organon Usa Inc	ZEMURON	rocuronium bromide	INJECTABLE;INJECTION	020214-002	Mar 17, 1994	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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