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Last Updated: March 28, 2024

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, Hengrui Pharma, Hikma, Hospira, Meitheal, Piramal Critical, Piramal Hlthcare Uk, Sagent Pharms Inc, Sandoz Inc, Somerset, Zydus Pharms, Somerset Theraps Llc, and Abbvie, and is included in twenty-eight NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for cisatracurium besylate
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Recent Clinical Trials for cisatracurium besylate

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SponsorPhase
Yichang Humanwell Pharmaceutical Co.,LtdPhase 4
Second Affiliated Hospital of Nanchang UniversityPhase 4
Second Affiliated Hospital of Nanchang UniversityN/A

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Pharmacology for cisatracurium besylate
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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Accord Hlthcare CISATRACURIUM BESYLATE PRESERVATIVE FREE cisatracurium besylate INJECTABLE;INJECTION 205872-001 Jun 16, 2017 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Somerset CISATRACURIUM BESYLATE cisatracurium besylate INJECTABLE;INJECTION 209132-001 Apr 24, 2019 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Zydus Pharms CISATRACURIUM BESYLATE cisatracurium besylate INJECTABLE;INJECTION 213527-001 Aug 31, 2020 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Piramal Hlthcare Uk CISATRACURIUM BESYLATE cisatracurium besylate INJECTABLE;INJECTION 212432-001 Mar 11, 2022 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sagent Pharms Inc CISATRACURIUM BESYLATE cisatracurium besylate INJECTABLE;INJECTION 201851-001 Nov 6, 2020 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hengrui Pharma CISATRACURIUM BESYLATE cisatracurium besylate INJECTABLE;INJECTION 209334-001 Aug 30, 2017 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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

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

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