You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: January 5, 2025

FENOLDOPAM MESYLATE Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Which patents cover Fenoldopam Mesylate, and when can generic versions of Fenoldopam Mesylate launch?

Fenoldopam Mesylate is a drug marketed by Hikma, Luitpold, Sandoz, and Teva Parenteral. and is included in four NDAs.

The generic ingredient in FENOLDOPAM MESYLATE is fenoldopam mesylate. There are five drug master file entries for this compound. Additional details are available on the fenoldopam mesylate profile page.

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for FENOLDOPAM MESYLATE?
  • What are the global sales for FENOLDOPAM MESYLATE?
  • What is Average Wholesale Price for FENOLDOPAM MESYLATE?
Summary for FENOLDOPAM MESYLATE
Drug patent expirations by year for FENOLDOPAM MESYLATE
Recent Clinical Trials for FENOLDOPAM MESYLATE

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

SponsorPhase
University of Roma La SapienzaPhase 4
Southeast Renal Research InstitutePhase 4
Dialysis Clinic, Inc.Phase 2/Phase 3

See all FENOLDOPAM MESYLATE clinical trials

Medical Subject Heading (MeSH) Categories for FENOLDOPAM MESYLATE

US Patents and Regulatory Information for FENOLDOPAM MESYLATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hikma FENOLDOPAM MESYLATE fenoldopam mesylate INJECTABLE;INJECTION 076582-001 Oct 12, 2004 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva Parenteral FENOLDOPAM MESYLATE fenoldopam mesylate INJECTABLE;INJECTION 077826-001 Mar 7, 2007 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Luitpold FENOLDOPAM MESYLATE fenoldopam mesylate INJECTABLE;INJECTION 076656-001 Dec 1, 2003 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sandoz FENOLDOPAM MESYLATE fenoldopam mesylate INJECTABLE;INJECTION 077155-001 Feb 15, 2005 DISCN No No ⤷  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

FENOLDOPAM MESYLATE Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Fenoldopam Mesylate

Introduction

Fenoldopam mesylate, a selective dopamine-1 receptor agonist, is primarily used for the in-hospital management of severe hypertension and has been explored for its potential in preventing and managing various renal complications. Here, we delve into the market dynamics and financial trajectory of this drug.

Market Size and Growth

The global fenoldopam mesylate injection market has been experiencing steady growth. As of 2024, the market size was valued at USD 300.48 million. Projections indicate that this market is expected to expand, reaching USD 431.34 million by 2031, reflecting a significant growth trajectory over the next several years[4].

Key Drivers of Market Growth

Several factors are driving the growth of the fenoldopam mesylate market:

Increasing Prevalence of Hypertension

The rising incidence of severe hypertension, particularly in elderly and critically ill patients, is a major driver. Fenoldopam mesylate's rapid-acting and reversible effects make it a preferred choice in emergency settings[1].

Potential in Renal Protection

The drug's ability to preserve renal blood flow and its potential in preventing contrast-induced nephropathy and acute kidney injury (AKI) are significant factors. Although results have been mixed, the reno-protective role of fenoldopam mesylate continues to be a focus of clinical research[2][3].

Expanding Clinical Applications

Beyond hypertension, fenoldopam mesylate is being studied for its efficacy in postoperative AKI, intensive care unit patients, and other renal-related conditions. Positive outcomes in these areas could further boost market demand[3].

Market Challenges

Despite the growth potential, there are several challenges that the fenoldopam mesylate market faces:

Mixed Clinical Outcomes

Some clinical trials have shown mixed or inconclusive results regarding the drug's efficacy in preventing contrast-induced nephropathy and other renal complications. For instance, a large-scale multicenter trial found no significant difference in preventing contrast-induced nephropathy between fenoldopam and placebo groups[2].

Side Effects and Safety Concerns

Fenoldopam mesylate can cause adverse reactions such as headache, cutaneous dilation, nausea, and hypotension. Additionally, it contains sodium metabisulfite, which can trigger allergic reactions in susceptible individuals, particularly those with asthma[1].

Competition from Alternative Treatments

The market for hypertension and renal protection treatments is competitive, with various other drugs and therapies available. Fenoldopam mesylate must compete with these alternatives, which can impact its market share.

Financial Performance and Projections

The financial performance of the fenoldopam mesylate market is influenced by several factors:

Revenue Growth

The projected growth from USD 300.48 million in 2024 to USD 431.34 million by 2031 indicates a robust revenue trajectory. This growth is driven by increasing demand and expanding clinical applications[4].

Cost and Pricing Strategies

The cost of fenoldopam mesylate can vary based on the region, hospital settings, and insurance coverage. Effective pricing strategies that balance profitability with patient accessibility are crucial for maintaining market share.

Research and Development Investments

Continued investment in clinical trials and research to establish the efficacy of fenoldopam mesylate in various indications is essential. Positive outcomes from these studies can significantly impact the drug's market performance.

Regional Market Dynamics

The market for fenoldopam mesylate is not uniform across all regions:

North America and Europe

These regions are expected to be major contributors to the market growth due to advanced healthcare infrastructure and higher adoption rates of new treatments.

Emerging Markets

Countries in Asia and Latin America are also showing potential for growth, driven by increasing healthcare spending and a rising awareness of hypertension and renal diseases.

Key Takeaways

  • The global fenoldopam mesylate injection market is projected to grow significantly, driven by increasing demand for hypertension management and potential renal protective effects.
  • Mixed clinical outcomes and safety concerns present challenges that need to be addressed.
  • Effective pricing strategies and continued investment in research are crucial for maintaining market share.
  • Regional dynamics play a significant role in the market's overall performance.

FAQs

  1. What is the primary indication for fenoldopam mesylate? Fenoldopam mesylate is primarily indicated for the in-hospital, short-term management of severe hypertension[1].

  2. What are the potential renal protective effects of fenoldopam mesylate? Fenoldopam mesylate has shown promise in preserving renal blood flow and reducing the onset of postoperative acute kidney injury (AKI) and contrast-induced nephropathy, although results have been mixed[2][3].

  3. What are the common side effects of fenoldopam mesylate? Common side effects include headache, cutaneous dilation, nausea, and hypotension. It also contains sodium metabisulfite, which can cause allergic reactions in susceptible individuals[1].

  4. What is the projected market size for fenoldopam mesylate by 2031? The market is projected to reach USD 431.34 million by 2031[4].

  5. Why is fenoldopam mesylate important in clinical settings? Fenoldopam mesylate is important due to its rapid-acting and reversible effects, making it a preferred choice in emergency hypertension management and its potential in renal protection[1][2].

Cited Sources:

  1. CORLOPAM (fenoldopam mesylate injection, USP) - US https://www.pfizermedicalinformation.com/corlopam

  2. Fenoldopam Mesylate for the Prevention of Contrast-Induced Nephropathy https://jamanetwork.com/journals/jama/fullarticle/197578

  3. A Narrative Review of Its Use in Acute Kidney Injury - Eurekaselect https://www.eurekaselect.com/article/98135

  4. Fenoldopam Mesylate Injection Market - Proficient Market Insights https://www.proficientmarketinsights.com/market-reports/fenoldopam-mesylate-injection-market-1953

  5. Fenoldopam mesylate in early acute tubular necrosis - PubMed https://pubmed.ncbi.nlm.nih.gov/15983954/

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.