CISATRACURIUM BESYLATE Drug Patent Profile
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Which patents cover Cisatracurium Besylate, and what generic alternatives are available?
Cisatracurium Besylate is a drug 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, and Somerset Theraps Llc. and is included in twenty-eight NDAs.
The generic ingredient in CISATRACURIUM BESYLATE is cisatracurium besylate. There are nine drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the cisatracurium besylate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Cisatracurium Besylate
A generic version of CISATRACURIUM BESYLATE was approved as cisatracurium besylate by SANDOZ INC on February 3rd, 2012.
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Summary for CISATRACURIUM BESYLATE
| US Patents: | 0 |
| Applicants: | 16 |
| NDAs: | 28 |
| Finished Product Suppliers / Packagers: | 16 |
| Raw Ingredient (Bulk) Api Vendors: | 63 |
| Clinical Trials: | 12 |
| Patent Applications: | 696 |
| Drug Prices: | Drug price information for CISATRACURIUM BESYLATE |
| DailyMed Link: | CISATRACURIUM BESYLATE at DailyMed |
Recent Clinical Trials for CISATRACURIUM BESYLATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Yichang Humanwell Pharmaceutical Co.,Ltd | Phase 4 |
| Second Affiliated Hospital of Nanchang University | Phase 4 |
| Second Affiliated Hospital of Nanchang University | N/A |
Pharmacology for CISATRACURIUM BESYLATE
| Drug Class | Nondepolarizing Neuromuscular Blocker |
| Physiological Effect | Neuromuscular Nondepolarizing Blockade |
Anatomical Therapeutic Chemical (ATC) Classes 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sandoz Inc | CISATRACURIUM BESYLATE PRESERVATIVE FREE | cisatracurium besylate | INJECTABLE;INJECTION | 200154-002 | Feb 3, 2012 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Accord Hlthcare | CISATRACURIUM BESYLATE PRESERVATIVE FREE | cisatracurium besylate | INJECTABLE;INJECTION | 205872-002 | Jun 16, 2017 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Zydus Pharms | CISATRACURIUM BESYLATE | cisatracurium besylate | INJECTABLE;INJECTION | 212171-001 | Nov 4, 2019 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Eugia Pharma | CISATRACURIUM BESYLATE PRESERVATIVE FREE | cisatracurium besylate | INJECTABLE;INJECTION | 209665-001 | Oct 27, 2020 | 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 |
