SODIUM NITROPRUSSIDE - Generic Drug Details

What are the generic 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, Vpna, Abraxis Pharm, Amneal, Amphastar Pharms Inc, Avet Lifesciences, Baxter Hlthcare, Be Pharms, Caplin, Chartwell Rx, Cipla, Dr Reddys, Epic Pharma Llc, Eugia Pharma, Micro Labs, Mylan Labs Ltd, Nexus, Norvium Bioscience, Sagent Pharms Inc, Slate Run Pharma, Somerset Theraps Llc, Sun Pharm, Teva Parenteral, Xiromed, and Exela Pharma, and is included in twenty-nine NDAs. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for sodium nitroprusside. Sixteen suppliers are listed for this compound.

Summary for SODIUM NITROPRUSSIDE

US Patents:	0
Tradenames:	4
Applicants:	28
NDAs:	29
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	16
Raw Ingredient (Bulk) Api Vendors:	42
Clinical Trials:	76
Patent Applications:	95
Drug Prices:	Drug price trends for SODIUM NITROPRUSSIDE
What excipients (inactive ingredients) are in SODIUM NITROPRUSSIDE?	SODIUM NITROPRUSSIDE excipients list
DailyMed Link:	SODIUM NITROPRUSSIDE at DailyMed

See drug prices for SODIUM NITROPRUSSIDE

Recent Clinical Trials for SODIUM NITROPRUSSIDE

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

Sponsor	Phase
Egymedicalpedia	Early Phase 1
Tanta University	N/A
Kafrelsheikh University	N/A

See all SODIUM NITROPRUSSIDE clinical trials

Pharmacology for SODIUM NITROPRUSSIDE

Drug Class	Vasodilator
Physiological Effect	Vasodilation

Anatomical Therapeutic Chemical (ATC) Classes for SODIUM NITROPRUSSIDE

C02DD	Nitroferricyanide derivatives
C02D	ARTERIOLAR SMOOTH MUSCLE, AGENTS ACTING ON
C02	ANTIHYPERTENSIVES
C	Cardiovascular system

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	SODIUM NITROPRUSSIDE	sodium nitroprusside	INJECTABLE;INJECTION	210114-001	Apr 10, 2019	AP	RX	No	No
Cipla	SODIUM NITROPRUSSIDE	sodium nitroprusside	INJECTABLE;INJECTION	210855-001	Jul 16, 2018		DISCN	No	No
Hospira	NITROPRESS	sodium nitroprusside	INJECTABLE;INJECTION	070566-001	Jun 9, 1986		DISCN	No	No
Norvium Bioscience	SODIUM NITROPRUSSIDE	sodium nitroprusside	INJECTABLE;INJECTION	209584-001	Aug 10, 2018	AP	RX	No	No
Chartwell Rx	SODIUM NITROPRUSSIDE	sodium nitroprusside	INJECTABLE;INJECTION	209834-001	Jun 26, 2018		DISCN	No	No

SODIUM NITROPRUSSIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Sodium Nitroprusside

Introduction

Sodium nitroprusside (SNP) is a potent vasodilator that has been a cornerstone in the management of acute hypertension and other critical cardiovascular conditions for decades. However, its market dynamics and financial trajectory have undergone significant changes in recent years, driven by factors such as pricing, availability of alternative treatments, and regulatory considerations.

Historical Pricing and Cost Implications

Prior to 2013, sodium nitroprusside was relatively inexpensive and an affordable option for treating acute hypertension. However, between 2013 and 2017, the average wholesale prices for SNP skyrocketed, reaching as high as $900 per vial, earning it the label of a "hyperinflation drug"[1].

Impact of Price Increases

The dramatic price increase posed a significant challenge for pharmacy departments and healthcare institutions. This led to a multidisciplinary effort to develop cost containment strategies, including therapeutic interchanges where alternative drugs with similar efficacy were substituted for SNP. Drugs like clevidipine and nicardipine, which are IV titratable antihypertensive agents, emerged as viable alternatives for managing hypertensive crises and postoperative hypertension[1].

Alternative Treatments and Cost Savings

Clevidipine and nicardipine have been shown to be effective substitutes for SNP, offering favorable pharmacokinetic and safety profiles. Several studies and hospital reports indicate that substituting these drugs for SNP resulted in significant cost savings without adverse outcomes. This shift has been a key factor in managing the financial burden associated with SNP's price inflation[1].

Market Demand and Usage

Despite the challenges posed by its pricing, sodium nitroprusside remains a crucial medication due to its rapid onset of action and effectiveness in acute settings. It is used in various clinical scenarios, including acute hypertensive crises, acute decompensated heart failure, and induction of perioperative hypotension to reduce blood loss during surgery[2][4].

Regulatory and Approval Status

Sodium nitroprusside has been FDA-approved since 1974 for the treatment of severe hypertension. It is also approved for use in other countries and is listed on the World Health Organization's List of Essential Medicines. However, its use is regulated due to potential side effects such as cyanide toxicity and methemoglobinemia[2][4].

Mechanism of Action and Clinical Utility

The drug's mechanism of action involves the release of nitric oxide (NO), which leads to the relaxation of vascular smooth muscle, resulting in peripheral vasodilation. This makes SNP particularly useful in situations requiring immediate reduction in preload or afterload. Its rapid onset and short duration of action are critical in managing acute cardiovascular emergencies[2][4].

Side Effects and Safety Considerations

While SNP is effective, it is not without risks. Common side effects include low blood pressure and cyanide toxicity, with more serious effects such as methemoglobinemia. High doses are not recommended for extended periods, and its use during pregnancy is generally not advised due to potential side effects[2][4].

Emerging Applications and Research

Beyond its traditional medical uses, sodium nitroprusside has emerging applications in fields such as microbiology and physiology research. It is used to disrupt microbial biofilms and has shown synergy with nitrate in inhibiting the activity of sulfate-reducing bacteria (SRB) in oil reservoirs[5].

Financial Trajectory and Cost Containment

The financial trajectory of SNP has been marked by significant price volatility. The hyperinflation period between 2013 and 2017 led to a search for cost-effective alternatives. The adoption of clevidipine and nicardipine as substitutes has helped in containing costs. However, the ongoing demand for SNP due to its unique clinical benefits ensures that it remains a part of hospital formularies, albeit with careful management of its financial impact[1].

Industry Response and Strategies

Pharmaceutical companies and healthcare institutions have responded to the pricing challenges by implementing various strategies. These include therapeutic interchanges, bulk purchasing agreements, and negotiations with suppliers to reduce costs. Additionally, there is a focus on developing and promoting alternative treatments that offer similar efficacy at a lower cost[1].

Future Outlook

The future outlook for sodium nitroprusside is complex. While it remains an essential medication, its pricing will continue to be a point of focus. The development of generic versions and the increasing use of alternative drugs are expected to influence its market dynamics. Regulatory bodies and healthcare institutions will need to balance the clinical need for SNP with the financial realities of its use.

Key Takeaways

• Pricing Volatility: Sodium nitroprusside experienced a significant price increase between 2013 and 2017, leading to it being labeled a "hyperinflation drug."
• Alternative Treatments: Clevidipine and nicardipine have emerged as effective and cost-saving alternatives for managing acute hypertension.
• Clinical Utility: SNP remains crucial for its rapid onset and effectiveness in acute cardiovascular settings.
• Safety Considerations: The drug has potential side effects, including cyanide toxicity and methemoglobinemia.
• Emerging Applications: Beyond traditional medical use, SNP has applications in microbiology and physiology research.
• Financial Management: Strategies such as therapeutic interchanges and bulk purchasing are being implemented to manage the financial impact of SNP.

FAQs

Q: What led to the significant price increase of sodium nitroprusside between 2013 and 2017? A: The exact reasons for the price increase are not fully detailed, but it is attributed to market dynamics and possibly supply chain issues, leading to it being classified as a "hyperinflation drug."

Q: What are the alternative treatments to sodium nitroprusside for managing acute hypertension? A: Clevidipine and nicardipine are IV titratable antihypertensive agents that have been shown to be effective alternatives to SNP.

Q: What are the common side effects of sodium nitroprusside? A: Common side effects include low blood pressure and cyanide toxicity, with more serious effects such as methemoglobinemia.

Q: Is sodium nitroprusside safe to use during pregnancy? A: No, it is generally not recommended during pregnancy due to concerns about side effects.

Q: What are some emerging applications of sodium nitroprusside beyond its traditional medical use? A: It is used in microbiology to disrupt microbial biofilms and has shown synergy with nitrate in inhibiting the activity of sulfate-reducing bacteria in oil reservoirs.

Sources

1. Sodium Nitroprusside as a Hyperinflation Drug and Therapeutic Interchange - PubMed[1]
2. Sodium Nitroprusside - StatPearls - NCBI Bookshelf - NCBI[2]
3. Sodium Nitroprusside - Wikipedia[4]
4. Synergy of Sodium Nitroprusside and Nitrate in Inhibiting the Activity of Sulfate-Reducing Bacteria - Frontiers in Microbiology[5]