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Sodium nitroprusside - Generic Drug Details
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What are the generic drug sources for sodium nitroprusside and what is the scope of freedom to operate?
Sodium nitroprusside
is the generic ingredient in four branded drugs marketed by Roche, Abbott, Abbvie, Hospira, Abraxis Pharm, Akorn, Amneal Pharms Co, Amphastar Pharms Inc, Baxter Hlthcare, Cipla, Dr Reddys Labs Ltd, Medicure, Micro Labs, Mylan Labs Ltd, Nexus Pharms, Sagent Pharms Inc, Somerset Theraps Llc, Sun Pharm, Teva Parenteral, Virtus Pharm, and Exela Pharma Scs Llc, and is included in twenty-two NDAs. Additional information is available in the individual branded drug profile pages.There are one thousand four hundred and seventy-two drug master file entries for sodium nitroprusside. Twelve suppliers are listed for this compound.
Summary for sodium nitroprusside
| US Patents: | 0 |
| Tradenames: | 4 |
| Applicants: | 21 |
| NDAs: | 22 |
| Drug Master File Entries: | 1472 |
| Suppliers / Packagers: | 12 |
| Clinical Trials: | 52 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | sodium nitroprusside at DailyMed |
Recent Clinical Trials for sodium nitroprusside
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Penn State University | Phase 1/Phase 2 |
| Colorado State University | Early Phase 1 |
| Cristália Produtos Químicos Farmacêuticos Ltda. | Phase 4 |
Pharmacology for sodium nitroprusside
| Drug Class | Vasodilator |
| Physiological Effect | Vasodilation |
US Patents and Regulatory Information for sodium nitroprusside
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dr Reddys Labs Ltd | SODIUM NITROPRUSSIDE | sodium nitroprusside | INJECTABLE;INJECTION | 210114-001 | Apr 10, 2019 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Sagent Pharms Inc | SODIUM NITROPRUSSIDE | sodium nitroprusside | INJECTABLE;INJECTION | 207426-001 | Dec 8, 2016 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Somerset Theraps Llc | SODIUM NITROPRUSSIDE | sodium nitroprusside | INJECTABLE;INJECTION | 210882-001 | Aug 17, 2018 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Medicure | SODIUM NITROPRUSSIDE | sodium nitroprusside | INJECTABLE;INJECTION | 209584-001 | Aug 10, 2018 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Teva Parenteral | SODIUM NITROPRUSSIDE | sodium nitroprusside | INJECTABLE;INJECTION | 073465-001 | Mar 30, 1992 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Abbvie | NITROPRESS | sodium nitroprusside | INJECTABLE;INJECTION | 018450-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Hospira | NITROPRESS | sodium nitroprusside | INJECTABLE;INJECTION | 071961-001 | Aug 1, 1988 | AP | RX | No | Yes | Start Trial | Start Trial | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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