CISATRACURIUM BESYLATE - Generic Drug Details

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What are the generic drug sources for cisatracurium besylate and what is the scope of freedom to operate?

Cisatracurium besylate is the generic ingredient in four branded drugs marketed by Accord Hlthcare, Caplin, Eugia Pharma, Fresenius Kabi Usa, Hainan Poly, Hengrui Pharma, Hikma, Hospira, Meitheal, Piramal, Piramal Critical, Sagent Pharms Inc, Sandoz Inc, Somerset, Zydus Pharms, Somerset Theraps Llc, and Abbvie, and is included in twenty-nine NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for cisatracurium besylate. Sixteen suppliers are listed for this compound.

Summary for CISATRACURIUM BESYLATE

US Patents:	0
Tradenames:	4
Applicants:	17
NDAs:	29
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	16
Raw Ingredient (Bulk) Api Vendors:	63
Clinical Trials:	12
Patent Applications:	1,228
Drug Prices:	Drug price trends for CISATRACURIUM BESYLATE
What excipients (inactive ingredients) are in CISATRACURIUM BESYLATE?	CISATRACURIUM BESYLATE excipients list
DailyMed Link:	CISATRACURIUM BESYLATE at DailyMed

See drug prices for CISATRACURIUM BESYLATE

Recent Clinical Trials for CISATRACURIUM BESYLATE

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

Sponsor	Phase
Second Affiliated Hospital of Nanchang University	Phase 4
Yichang Humanwell Pharmaceutical Co.,Ltd	Phase 4
Second Affiliated Hospital of Nanchang University	N/A

See all CISATRACURIUM BESYLATE clinical trials

Pharmacology for CISATRACURIUM BESYLATE

Drug Class	Nondepolarizing Neuromuscular Blocker
Physiological Effect	Neuromuscular Nondepolarizing Blockade

Anatomical Therapeutic Chemical (ATC) Classes for CISATRACURIUM BESYLATE

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

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

Paragraph IV (Patent) Challenges for CISATRACURIUM BESYLATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NIMBEX PRESERVATIVE FREE	Injection	cisatracurium besylate	2 mg/mL, 10 mL vial	020551	1	2009-08-12
NIMBEX PRESERVATIVE FREE	Injection	cisatracurium besylate	2 mg/mL, 5 mL vial and 10 mg/mL, 20 mL vial	020551	1	2009-08-04

US Patents and Regulatory Information for CISATRACURIUM BESYLATE

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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	CISATRACURIUM BESYLATE	cisatracurium besylate	INJECTABLE;INJECTION	203236-001	Mar 30, 2018	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abbvie	NIMBEX PRESERVATIVE FREE	cisatracurium besylate	INJECTABLE;INJECTION	020551-002	Dec 15, 1995		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hengrui Pharma	CISATRACURIUM BESYLATE PRESERVATIVE FREE	cisatracurium besylate	INJECTABLE;INJECTION	204960-001	Jan 27, 2017	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 CISATRACURIUM BESYLATE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	NIMBEX	cisatracurium besylate	INJECTABLE;INJECTION	020551-001	Dec 15, 1995	⤷ Sign Up	⤷ Sign Up
Abbvie	NIMBEX PRESERVATIVE FREE	cisatracurium besylate	INJECTABLE;INJECTION	020551-003	Dec 15, 1995	⤷ Sign Up	⤷ Sign Up
Abbvie	NIMBEX PRESERVATIVE FREE	cisatracurium besylate	INJECTABLE;INJECTION	020551-002	Dec 15, 1995	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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