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Last Updated: December 22, 2024

NIPRIDE Drug Patent Profile


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Which patents cover Nipride, and what generic alternatives are available?

Nipride is a drug marketed by Roche and Exela Pharma and is included in two NDAs.

The generic ingredient in NIPRIDE is sodium nitroprusside. There are one thousand four hundred and seventy-two drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the sodium nitroprusside profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Nipride

A generic version of NIPRIDE was approved as sodium nitroprusside by SAGENT PHARMS INC on December 8th, 2016.

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  • What is the 5 year forecast for NIPRIDE?
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  • What is Average Wholesale Price for NIPRIDE?
Summary for NIPRIDE
US Patents:0
Applicants:2
NDAs:2
Clinical Trials: 3
Drug Prices: Drug price information for NIPRIDE
DailyMed Link:NIPRIDE at DailyMed
Drug patent expirations by year for NIPRIDE
Drug Prices for NIPRIDE

See drug prices for NIPRIDE

Recent Clinical Trials for NIPRIDE

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

SponsorPhase
University of AlbertaN/A
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Phase 2
Curt TreuN/A

See all NIPRIDE clinical trials

US Patents and Regulatory Information for NIPRIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Roche NIPRIDE sodium nitroprusside INJECTABLE;INJECTION 017546-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Exela Pharma NIPRIDE RTU IN SODIUM CHLORIDE 0.9% sodium nitroprusside SOLUTION;INTRAVENOUS 209387-001 Mar 8, 2017 AP RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Exela Pharma NIPRIDE RTU IN SODIUM CHLORIDE 0.9% sodium nitroprusside SOLUTION;INTRAVENOUS 209387-002 Dec 7, 2017 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Exela Pharma NIPRIDE RTU IN SODIUM CHLORIDE 0.9% sodium nitroprusside SOLUTION;INTRAVENOUS 209387-003 Jul 13, 2018 AP RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

NIPRIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Sodium Nitroprusside (NIPRIDE)

Introduction

Sodium nitroprusside (SNP), commonly known by its brand name NIPRIDE, is a rapid-acting intravenous (IV) vasodilator used to treat acute hypertension, hypertensive crises, and to induce controlled hypotension during surgery. This article delves into the market dynamics and financial trajectory of SNP, highlighting its pricing trends, alternative treatments, and strategies hospitals use to manage rising drug costs.

Historical Pricing and Hyperinflation

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

Impact on Healthcare Costs

The dramatic increase in SNP prices significantly affected healthcare costs. In 2016, prescription drug sales accounted for $448.8 billion of total health costs in the U.S., with half of this increase attributed to price hikes rather than increased prescriptions[3].

Alternative Treatments

To mitigate the financial burden of SNP, hospitals have sought alternative treatments. Clevidipine and nicardipine, both dihydropyridine calcium channel blockers, have emerged as effective substitutes. These IV titratable antihypertensive agents have favorable pharmacokinetic and safety profiles, making them viable options for managing hypertensive crises and postoperative hypertension[1].

Cost-Effectiveness of Alternatives

The Cleveland Clinic, for instance, initially opted against using clevidipine due to its high price but later adopted it as a cost-effective alternative when SNP prices surged. This switch saved the hospital an estimated $8 million annually[3].

Market Fluctuations and Monopolies

The life cycles of generic medications, including SNP, have led to monopolies that drive up prices. When a generic drug becomes the sole source for a particular condition, manufacturers can significantly increase prices without facing immediate competition[3].

Hospital Strategies for Cost Management

Hospitals employ several strategies to manage rising drug costs:

Therapeutic Interchange

Therapeutic interchange involves substituting a drug with a similar efficacy profile. For SNP, clevidipine and nicardipine are often used as substitutes, providing significant cost savings without compromising patient outcomes[1].

Monitoring Price Changes

Hospitals use dashboards to track price changes every two weeks, comparing old prices to new ones and adjusting their purchasing strategies accordingly. This proactive approach helps in identifying cost-effective alternatives and negotiating better contracts with suppliers[3].

Biosimilars

Biosimilars, which are biologic drugs with similar efficacy to branded biologics, offer another avenue for cost reduction. While biosimilars are more commonly used in Europe and Japan, their adoption in the U.S. is growing, promising significant savings on biologic therapies[3].

Financial Impact on Hospitals

The financial impact of rising drug costs is substantial. For example, the Cleveland Clinic spends $30 to $40 million annually on infliximab, a biologic drug. The potential savings from using biosimilars could be significant, helping hospitals maintain positive earnings and cash flow[3].

Pharmaceutical Company Strategies

Companies like Medicure Inc., which markets and distributes SNP, have to navigate these market dynamics carefully. Medicure has focused on expanding its product offerings, including high-margin IV and solid dose products, and has made strategic acquisitions to maintain profitability[2].

Regulatory Environment

The FDA plays a crucial role in regulating drug prices and ensuring safety. For SNP, the FDA has assessed drug utilization patterns and adverse event reports to provide context for its use, particularly in pediatric patients[4].

Patient Impact

The high cost of SNP and other essential medications can have a direct impact on patient care. Hospitals must balance the need for effective treatments with the financial constraints imposed by rising drug prices. Alternative treatments and cost-management strategies are essential to ensuring that patients receive the care they need without compromising hospital finances.

Key Takeaways

  • Pricing Trends: SNP prices have skyrocketed, making it a hyperinflation drug.
  • Alternative Treatments: Clevidipine and nicardipine are effective and cost-effective alternatives to SNP.
  • Hospital Strategies: Therapeutic interchange, monitoring price changes, and adopting biosimilars are key strategies for managing rising drug costs.
  • Financial Impact: Rising drug costs significantly affect hospital finances, necessitating proactive cost-management strategies.
  • Regulatory Environment: The FDA plays a critical role in regulating drug use and safety.

FAQs

Q: What is the primary reason for the significant increase in SNP prices? A: The primary reason is the lack of competition, leading to monopolistic pricing.

Q: What are the alternative treatments to SNP for managing acute hypertension? A: Clevidipine and nicardipine are commonly used alternatives.

Q: How do hospitals manage the financial impact of rising drug costs? A: Hospitals use therapeutic interchange, monitor price changes regularly, and consider biosimilars to manage costs.

Q: What role does the FDA play in regulating SNP? A: The FDA assesses drug utilization patterns, adverse event reports, and ensures safety, particularly in pediatric patients.

Q: How have pharmaceutical companies like Medicure Inc. responded to rising drug costs? A: Companies have expanded their product offerings, made strategic acquisitions, and focused on high-margin products to maintain profitability.

Sources

  1. Sodium Nitroprusside as a Hyperinflation Drug and Therapeutic Interchange with Clevidipine or Nicardipine - PubMed
  2. Medicure Inc. - Investor Presentation - Medicure
  3. Ten ways hospitals can manage rising drug costs - Managed Healthcare Executive
  4. Nitropress® (sodium nitroprusside) injection - FDA - FDA

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