HEPARIN LOCK FLUSH Drug Patent Profile

When do Heparin Lock Flush patents expire, and when can generic versions of Heparin Lock Flush launch?

Heparin Lock Flush is a drug marketed by Hospira, Intl Medication, Luitpold, Parke Davis, Smith And Nephew, and Solopak. and is included in seventeen NDAs.

The generic ingredient in HEPARIN LOCK FLUSH 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 Lock Flush

A generic version of HEPARIN LOCK FLUSH was approved as heparin sodium by HOSPIRA on April 28^th, 1983.

Summary for HEPARIN LOCK FLUSH

US Patents:	0
Applicants:	6
NDAs:	17
Clinical Trials:	1,022
DailyMed Link:	HEPARIN LOCK FLUSH at DailyMed

Recent Clinical Trials for HEPARIN LOCK FLUSH

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

Sponsor	Phase
University Hospital, Angers	Phase 3
Fertility Center of Las Vegas	Phase 4
Sydney Local Health District	Phase 2

See all HEPARIN LOCK FLUSH clinical trials

US Patents and Regulatory Information for HEPARIN LOCK FLUSH

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hospira	HEPARIN LOCK FLUSH	heparin sodium	INJECTABLE;INJECTION	005264-010	Approved Prior to Jan 1, 1982		DISCN	No	No
Smith And Nephew	HEPARIN LOCK FLUSH	heparin sodium	INJECTABLE;INJECTION	087904-001	Apr 20, 1983		DISCN	No	No
Smith And Nephew	HEPARIN LOCK FLUSH	heparin sodium	INJECTABLE;INJECTION	087958-001	Apr 20, 1983		DISCN	No	No
Smith And Nephew	HEPARIN LOCK FLUSH	heparin sodium	INJECTABLE;INJECTION	087959-001	Apr 20, 1983		DISCN	No	No
Solopak	HEPARIN LOCK FLUSH	heparin sodium	INJECTABLE;INJECTION	088457-001	Oct 25, 1984		DISCN	No	No
Solopak	HEPARIN LOCK FLUSH	heparin sodium	INJECTABLE;INJECTION	088459-001	Jul 26, 1984		DISCN	No	No
Luitpold	HEPARIN LOCK FLUSH	heparin sodium	INJECTABLE;INJECTION	089063-001	Oct 9, 1985		DISCN	No	No

Market Dynamics and Financial Trajectory for Heparin Lock Flush

Introduction

Heparin lock flush, a crucial component in maintaining the patency of intravenous access devices, is subject to various market dynamics and financial factors. This article delves into the current state, future projections, and key drivers influencing the heparin lock flush market.

Market Size and Growth

The global heparin market, which includes heparin lock flush solutions, was valued at USD 7.34 billion in 2023. It is projected to grow to USD 8.20 billion by 2030, with a Compound Annual Growth Rate (CAGR) of 1.6% during the forecast period of 2024-2030[3].

Product Types and Segmentation

The heparin market is segmented into two main product types: Unfractionated Heparin (UFH) and Low Molecular Weight Heparin (LMWH). LMWH dominates the market due to its more predictable anticoagulant effect and lower prevalence of heparin-induced thrombocytopenia. This segment is expected to continue its growth driven by the development of products with improved pharmacological properties, such as ultra-low molecular weight heparin[3].

End Users and Applications

Heparin lock flush solutions are primarily used in hospitals, Ambulatory Surgical Centers (ASCs), and clinics. The demand from these sectors is driven by the need to maintain intravenous access devices and prevent thrombosis. The increasing incidence of cardiovascular diseases and other conditions requiring anticoagulation therapy further fuels the demand for heparin lock flush solutions[3].

Route of Administration

Heparin lock flush solutions are administered either through intravenous infusion or subcutaneous injection. The intravenous route is more common for maintaining catheter patency, while subcutaneous injections are used for other anticoagulant therapies[3].

Regional Insights

North America is the dominant region in the heparin market, driven by the presence of major players such as Pfizer and Amphastar. The region's market was valued at $777.5 million in 2023 and is expected to grow due to the increasing prevalence of chronic diseases like cardiovascular disorders and genetic conditions such as inherited thrombophilia[3].

Emerging Markets

The Asia Pacific region is anticipated to grow at the fastest rate during the forecast period. This growth is attributed to the expanding healthcare infrastructure, economic development, and increasing private and public initiatives in countries like China and India. The aging population and rising incidence of cardiovascular diseases in these regions also contribute to the market growth[3].

Key Drivers

Several factors drive the market for heparin lock flush solutions:

• Technological Advancements: The introduction of new products with improved pharmacological properties, such as ultra-low molecular weight heparin, is expected to fuel market growth[3].
• Increasing Incidence of Cardiovascular Diseases: The rising frequency and incidence of cardiovascular illnesses globally drive the demand for anticoagulant therapies, including heparin lock flush solutions[3].
• Healthcare Infrastructure Expansion: The growth in healthcare infrastructure in emerging markets, particularly in the Asia Pacific region, is a significant driver[3].

Challenges and Limitations

Despite the growth prospects, the market faces several challenges:

• Supply Chain Disruptions: Recent shortages of heparin lock flush syringes, attributed to increased demand and manufacturing constraints, highlight the vulnerability of the supply chain[1].
• Regulatory Frameworks: The market is subject to stringent regulatory requirements, including FDA approvals and compliance with safety standards, which can impact product availability and innovation[2].

Financial Trajectory

The financial trajectory of the heparin lock flush market is positive, albeit with a moderate growth rate. Here are some key financial insights:

• Market Value: The global heparin market, including heparin lock flush solutions, is expected to grow from USD 7.34 billion in 2023 to USD 8.20 billion by 2030[3].
• Revenue Streams: Major revenue streams come from hospitals, ASCs, and clinics, with North America being the largest contributor due to the presence of key market players[3].

Competitive Landscape

The market for heparin lock flush solutions is competitive, with several key players:

• Baxter International Inc.
• B. Braun Holding GmbH & Co. KG
• Dr. Reddy’s Laboratories Ltd
• Fresenius SE & Co KGaA
• BD (Becton Dickinson)
• Medefil, Inc.

These companies focus on product innovation, expanding their geographic presence, and ensuring a stable supply chain to maintain market share[3].

Product Availability and Shortages

Recent shortages of heparin lock flush syringes have been reported due to increased demand and manufacturing constraints. Companies like BD, Fresenius Kabi, and Medefil have products available, but the market remains sensitive to supply chain disruptions[1].

Conclusion

The market for heparin lock flush solutions is driven by the increasing need for anticoagulant therapies, technological advancements, and the expansion of healthcare infrastructure. Despite challenges such as supply chain disruptions and regulatory hurdles, the market is expected to grow steadily over the forecast period.

Key Takeaways

• The global heparin market, including heparin lock flush solutions, is valued at USD 7.34 billion in 2023 and is expected to reach USD 8.20 billion by 2030.
• LMWH dominates the market due to its predictable anticoagulant effect and lower risk of heparin-induced thrombocytopenia.
• North America is the dominant region, with the Asia Pacific region expected to grow at the fastest rate.
• Technological advancements and the increasing incidence of cardiovascular diseases are key drivers.
• Supply chain disruptions and regulatory compliance are significant challenges.

FAQs

1. What is the current market size of the global heparin market? The global heparin market was valued at USD 7.34 billion in 2023[3].

2. What is the expected growth rate of the heparin market from 2024 to 2030? The heparin market is expected to grow at a CAGR of 1.6% from 2024 to 2030[3].

3. Which region dominates the heparin market? North America dominates the heparin market due to the presence of major players and a high prevalence of chronic diseases[3].

4. What are the main product types in the heparin market? The main product types are Unfractionated Heparin (UFH) and Low Molecular Weight Heparin (LMWH)[3].

5. Why is LMWH more popular than UFH? LMWH is more popular due to its more predictable anticoagulant effect and lower prevalence of heparin-induced thrombocytopenia[3].

Sources

1. American Society of Health-System Pharmacists. Drug Shortage Detail: Heparin Lock Flush.
2. U.S. Food and Drug Administration. 510k Summary: AM2PAT Heparin Lock Flush Syringe.
3. Maximize Market Research. Heparin Market - Dynamics, Impacts and Forecasts 2024-2030.