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

Last Updated: January 4, 2025

HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Which patents cover Heparin Sodium 10,000 Units In Dextrose 5% In Plastic Container, and when can generic versions of Heparin Sodium 10,000 Units In Dextrose 5% In Plastic Container launch?

Heparin Sodium 10,000 Units In Dextrose 5% In Plastic Container is a drug marketed by Hospira and is included in one NDA.

The generic ingredient in HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER is heparin sodium. There are seventy-seven drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the heparin sodium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Heparin Sodium 10,000 Units In Dextrose 5% In Plastic Container

A generic version of HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER was approved as heparin sodium by HOSPIRA on April 28th, 1983.

  Subscribe

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER?
  • What are the global sales for HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER?
  • What is Average Wholesale Price for HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER?
Summary for HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
Drug patent expirations by year for HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
Recent Clinical Trials for HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

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

SponsorPhase
Vaneltix Pharma, Inc.Phase 2
Prevail Infoworks, IncPhase 2
The First Affiliated Hospital with Nanjing Medical UniversityN/A

See all HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER clinical trials

Pharmacology for HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

US Patents and Regulatory Information for HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hospira HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER heparin sodium INJECTABLE;INJECTION 019339-003 Mar 27, 1985 AP RX 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

HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory of Heparin Sodium 10,000 Units in Dextrose 5% in Plastic Container

Introduction to Heparin Sodium

Heparin sodium, derived from porcine intestinal mucosa, is a widely used anticoagulant with a history spanning over 90 years. It is available in various formulations, including the 10,000 units in 5% dextrose injection, which is administered intravenously.

Market Size and Growth

The global heparin market has been experiencing significant growth, driven by several key factors. As of 2022, the global heparin market size was valued at approximately USD 5.49 billion and is projected to reach around USD 9.24 billion by 2032, growing at a CAGR of 5.40% during the forecast period from 2023 to 2032[5].

Regional Analysis

North America

North America has been the dominant region in the heparin market, generating the highest revenue share. This is largely due to the high prevalence of cardiovascular diseases and accidents in the region. The increasing healthcare spending and patient awareness in North America also contribute to its market leadership. For instance, cardiovascular disease is one of the leading causes of death in the United States, with one in four Americans dying from it each year[1].

Asia Pacific

The Asia-Pacific region is expected to exhibit the fastest growth in the heparin market during the forecast period. Key drivers include the increasing geriatric population, a large population suffering from chronic diseases, and the region's developing economy. Additionally, Asia-Pacific is a major supplier of active pharmaceutical ingredients (APIs) and crude heparin, benefiting local businesses such as Pharmax Lifesciences[1].

Market Segmentation

By Product

The heparin market is segmented into various product types, including unfractionated heparin, low molecular weight heparin (LMWH), ultra-low molecular weight heparin, and others. LMWH and unfractionated heparin are among the most favored anticoagulant medications due to their efficacy and pharmacological activities[5].

By Application

Heparin sodium is used in the treatment of various conditions, including:

  • Venous Thromboembolism: A major application area, given the high risk of blood clots in patients.
  • Cardioversion of Atrial Fibrillation/Flutter: Heparin is used to prevent thromboembolic complications during cardioversion procedures.
  • Complications of Pregnancy: It is used to manage thrombotic disorders in pregnant women.
  • Other Applications: Including the treatment of lung and cardiovascular conditions[3].

By Distribution Channel

The distribution channels for heparin sodium include hospital pharmacies, online pharmacies, and drug stores & retail pharmacies. Hospital pharmacies are a significant segment due to the frequent use of heparin in hospital settings[1].

Financial Trajectory

Revenue Forecast

The global heparin market is expected to grow from USD 8.3 billion in 2022 to approximately USD 13.0 billion by 2032, at a CAGR of 4.70% during the forecast period from 2023 to 2032[1].

Market Drivers

  • Increasing Chronic Conditions: The rise in chronic diseases such as cardiovascular diseases and venous thromboembolism is driving the demand for heparin.
  • Aging Population: The growing geriatric population, particularly in the Asia-Pacific region, is another significant driver.
  • Anti-inflammatory Properties: Heparin's additional anti-inflammatory properties make it a preferred choice over other anticoagulants, further boosting market growth[5].

Market Challenges

  • Supply Chain Issues: The reliance on porcine intestinal mucosa for heparin production can lead to supply chain disruptions, especially during pandemics or animal disease outbreaks.
  • Regulatory Compliance: Strict regulatory requirements and the need for continuous quality control can pose challenges for manufacturers.

Product Specifics: Heparin Sodium 10,000 Units in Dextrose 5%

Description

Heparin Sodium in 5% Dextrose Injection is a sterile, nonpyrogenic solution prepared from heparin sodium derived from porcine intestinal mucosa. It is standardized for anticoagulant activity and is administered intravenously. The solution is available in various concentrations, including 10,000 units in 5% dextrose injection[2][4].

Dosage and Administration

The dosage of heparin sodium should be adjusted according to the patient’s coagulation test results. When administered by continuous intravenous infusion, coagulation tests should be performed approximately every 4 hours during the early stages of therapy. The product should not be used as a “catheter lock flush” and should not be given orally or infused under pressure[2].

Packaging

The solution is packaged in latex-free, PVC-free, and DEHP-free plastic containers made from a multilayered film specifically developed for parenteral drugs. These containers exhibit virtually no leachables and are designed to ensure the stability and safety of the solution[2].

Competitive Landscape

The heparin market is competitive, with several key players involved in the production and distribution of heparin sodium. Local businesses in the Asia-Pacific region, such as Pharmax Lifesciences, benefit from the region's role as a major supplier of APIs and crude heparin. Global pharmaceutical companies also play a significant role in the market, contributing to the competitive landscape[1].

Impact of COVID-19

The COVID-19 pandemic has had a mixed impact on the heparin market. On one hand, the increased need for anticoagulants in treating COVID-19 patients has boosted demand. On the other hand, supply chain disruptions and manufacturing challenges have posed significant hurdles for the industry[1].

Future Outlook

Given the growing demand for anticoagulants and the expanding geriatric population, the heparin market is poised for continued growth. Innovations in product formulations and delivery systems, along with increasing healthcare spending, will further drive the market forward.

Key Takeaways

  • The global heparin market is projected to grow significantly, driven by increasing chronic conditions and an aging population.
  • North America is the current market leader, while the Asia-Pacific region is expected to show the fastest growth.
  • Heparin sodium's anti-inflammatory properties and its use in various medical conditions contribute to its market dominance.
  • The product is available in various concentrations, including the 10,000 units in 5% dextrose injection, which is administered intravenously.
  • The market faces challenges such as supply chain issues and regulatory compliance.

FAQs

Q: What is the expected growth rate of the global heparin market from 2023 to 2032?

A: The global heparin market is expected to grow at a CAGR of 5.40% from 2023 to 2032[5].

Q: Which region is expected to show the fastest growth in the heparin market?

A: The Asia-Pacific region is expected to exhibit the fastest growth in the heparin market during the forecast period[1].

Q: What are the main applications of heparin sodium?

A: Heparin sodium is used in the treatment of venous thromboembolism, complications of pregnancy, cardioversion of atrial fibrillation/flutter, and other cardiovascular and lung conditions[3].

Q: What are the key drivers of the heparin market?

A: The key drivers include the increase in chronic conditions, the growing geriatric population, and heparin's anti-inflammatory properties[5].

Q: How is heparin sodium administered?

A: Heparin sodium is administered intravenously, and the dosage should be adjusted according to the patient’s coagulation test results[2].

Sources

  1. Market.us, Heparin Market Size, Share, Growth | CAGR of 4.70%, https://market.us/report/heparin-market/
  2. FDA, Heparin Sodium in 5% Dextrose Injection, https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019952s030lbl.pdf
  3. Market Research Intellect, Global Heparin Sodium Injection Market Size and Forecast, https://www.marketresearchintellect.com/product/global-heparin-sodium-injection-market-size-and-forecast/
  4. FDA, Heparin Sodium in 5% Dextrose Injection, https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018814s032lbl.pdf
  5. Precedence Research, Heparin Market Size to Attain USD 9.24 Billion by 2032, https://www.precedenceresearch.com/press-release/heparin-market

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.