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Last Updated: December 22, 2024

LEVOPHED Drug Patent Profile


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When do Levophed patents expire, and when can generic versions of Levophed launch?

Levophed is a drug marketed by Hospira and is included in one NDA.

The generic ingredient in LEVOPHED is norepinephrine bitartrate. There are five drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the norepinephrine bitartrate profile page.

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Summary for LEVOPHED
Drug patent expirations by year for LEVOPHED
Drug Prices for LEVOPHED

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Recent Clinical Trials for LEVOPHED

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

SponsorPhase
Wright State UniversityPhase 3
Kasr El Aini HospitalPhase 4
Yale UniversityEarly Phase 1

See all LEVOPHED clinical trials

Pharmacology for LEVOPHED
Drug ClassCatecholamine

US Patents and Regulatory Information for LEVOPHED

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hospira LEVOPHED norepinephrine bitartrate INJECTABLE;INJECTION 007513-001 Approved Prior to Jan 1, 1982 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

LEVOPHED Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Levophed (Norepinephrine)

Introduction

Levophed, commonly known as norepinephrine, is a potent alpha/beta-agonist used in critical care settings to treat severe hypotension, shock, and bradycardia. The market for norepinephrine is experiencing significant growth, driven by several key factors.

Market Size and Growth Projections

The norepinephrine drug market has shown substantial growth in recent years. As of 2023, the market size was valued at approximately USD 391.26 million[1][4].

  • By 2036, the market is projected to reach USD 1.72 billion, growing at a Compound Annual Growth Rate (CAGR) of around 12.1% between 2024 and 2036[1].
  • Another projection indicates that the market will reach USD 871.9 million by 2031, growing at a CAGR of 12.2% from 2024 to 2031[4].

Growth Drivers

Several factors are driving the growth of the norepinephrine market:

Increasing Prevalence of Hypotension and Sepsis

The rising prevalence of low blood pressure conditions and sepsis-related shock globally is a significant driver. Effective vasopressor treatments like norepinephrine are increasingly necessary to manage these conditions[1][4].

Geriatric Population

The rapidly increasing geriatric population is another key factor. Older adults are more prone to cardiovascular illnesses and other conditions that require norepinephrine treatment, contributing to market growth[1].

Advances in Medical Emergency Response

Improvements in medical emergency response systems and critical care units have enhanced the rapid administration and management of shock situations, increasing the demand for norepinephrine[4].

Access to Healthcare

Growing access to essential drugs, including norepinephrine, due to rising healthcare costs and investments in intensive care units, is also driving market expansion[4].

Clinical Research and Development

Continued clinical research and development initiatives aimed at enhancing dosage schedules and broadening indications for norepinephrine are improving its therapeutic efficacy and safety profile, further propelling the market[4].

Regional Analysis

The global norepinephrine drug market is segmented into several major regions:

North America

North America is expected to account for the largest revenue share by 2036, driven by the rising geriatric population, early adoption of cutting-edge technology, and the significant presence of key market players in the region[1].

Asia-Pacific

The Asia-Pacific region is also expected to show upward growth due to the increasing population of geriatric individuals and the need for effective vasopressor treatments[1].

Product Types and Applications

The norepinephrine market is categorized based on type and application:

Types

  • Norepinephrine Bitartrate
  • Norepinephrine Hydrochloride[4]

Applications

  • Septic Shock
  • Hypotension[4]

Key Players

Several pharmaceutical companies are prominent in the norepinephrine market, including:

  • Pfizer
  • Baxter International
  • Hospira Inc.
  • Mylan Pharmaceuticals
  • Fresenius Kabi
  • Teva Pharmaceutical Industries
  • Amneal Pharmaceuticals
  • Sandoz International GmbH
  • Apotex Inc.
  • West-Ward Pharmaceuticals[4]

Clinical Use and Administration

Norepinephrine is administered as a drip, typically mixed with D5W (dextrose 5% in water), with a standard concentration of 16 mcg/ml. The drip is usually started at 2 mcg/min and titrated up to achieve normotensive blood pressure (MAP 60-65 mmHg or SBP >90 mmHg)[2].

Dosing and Titration

The dose is titrated every 20 minutes based on vital signs, which are monitored continuously. High doses do not improve outcomes and can lead to adverse effects such as post-resuscitation myocardial dysfunction, hyperglycemia, decreased urine output, and metabolic acidosis[2].

Challenges and Considerations

While the market is growing, there are several challenges to consider:

Supply and Demand

Ensuring adequate supply to meet the increasing demand is crucial. Initial supply shortages have been a concern, but drug companies are working to address these issues[1][4].

Cost and Accessibility

The cost of norepinephrine and access to it, especially in regions with single-payer healthcare systems, can be a constraint. However, ongoing research and development may lead to more affordable formulations in the future[1].

Future Outlook

The future of the norepinephrine market looks promising, driven by the increasing need for effective vasopressor treatments and advancements in healthcare technology.

"The market for norepinephrine drugs is driven by several major factors. First, effective vasopressor treatments, such as norepinephrine, are required due to the increasing prevalence of cardiovascular illnesses and sepsis-related shock."[4]

Key Takeaways

  • The norepinephrine drug market is projected to grow significantly, reaching USD 1.72 billion by 2036.
  • Key drivers include the rising prevalence of hypotension and sepsis, the increasing geriatric population, and advancements in medical emergency response.
  • North America is expected to dominate the market, with the Asia-Pacific region showing significant growth.
  • The market is segmented by type (Norepinephrine Bitartrate and Hydrochloride) and application (Septic Shock and Hypotension).
  • Continuous clinical research and development are enhancing the therapeutic efficacy and safety profile of norepinephrine.

FAQs

What is the current market size of the norepinephrine drug market?

The norepinephrine drug market size was valued at approximately USD 391.26 million in 2023[1].

What is the projected growth rate of the norepinephrine market?

The market is projected to grow at a CAGR of around 12.1% from 2024 to 2036[1].

What are the primary applications of norepinephrine?

The primary applications of norepinephrine are in treating septic shock and hypotension[4].

Which region is expected to dominate the norepinephrine market?

North America is expected to account for the largest revenue share by 2036[1].

What are the common side effects of norepinephrine?

Common side effects include hyperglycemia, decreased urine output, metabolic acidosis, and potential post-resuscitation myocardial dysfunction[2].

Sources

  1. Research Nester: Norepinephrine Drug Market Size & Share, Growth Forecast 2036.
  2. CEU Fast: Vasoactive Drips: A guide to starting and titrating critical care drips, Adult and Pediatric.
  3. Goldman Sachs: Weighing the GLP-1 market.
  4. Market Research Intellect: Norepinephrine Drug Market Size and Projections.

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