Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 14, 2019

DrugPatentWatch Database Preview

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
Recent Clinical Trials for sodium nitroprusside

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

SponsorPhase
Penn State UniversityPhase 1/Phase 2
Colorado State UniversityEarly Phase 1
Cristália Produtos Químicos Farmacêuticos Ltda.Phase 4

See all sodium nitroprusside clinical trials

Pharmacology for sodium nitroprusside
Drug ClassVasodilator
Physiological EffectVasodilation

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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