HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER Drug Patent Profile

When do Heparin Sodium 12,500 Units In Dextrose 5% In Plastic Container patents expire, and when can generic versions of Heparin Sodium 12,500 Units In Dextrose 5% In Plastic Container launch?

Heparin Sodium 12,500 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 12,500 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 12,500 Units In Dextrose 5% In Plastic Container

A generic version of HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER was approved as heparin sodium by HOSPIRA on April 28^th, 1983.

Summary for HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	98
DailyMed Link:	HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER at DailyMed

Recent Clinical Trials for HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

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

Sponsor	Phase
Vaneltix Pharma, Inc.	Phase 2
Prevail Infoworks, Inc	Phase 2
The First Affiliated Hospital with Nanjing Medical University	N/A

See all HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER clinical trials

Pharmacology for HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

Drug Class

Anti-coagulant Unfractionated Heparin

US Patents and Regulatory Information for HEPARIN SODIUM 12,500 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 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	heparin sodium	INJECTABLE;INJECTION	019339-001	Mar 27, 1985		RX	No	No

HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Heparin Sodium 12,500 Units in Dextrose 5% in Plastic Containers

Introduction

Heparin sodium, particularly in 5% dextrose solutions, is a crucial anticoagulant used in various medical settings to prevent and treat thrombosis. The market dynamics and financial trajectory of this drug are influenced by several factors, including demand, supply chain issues, regulatory environments, and competitive landscapes.

Market Demand

The demand for heparin sodium in 5% dextrose solutions is steady and often driven by the need for anticoagulation in hospital settings. This includes use in cardiac surgeries, dialysis, and the treatment of deep vein thrombosis and pulmonary embolism. The consistent medical need ensures a stable demand, although it can fluctuate based on the prevalence of conditions requiring anticoagulation and the availability of alternative treatments[1][4].

Supply Chain and Manufacturing

The supply chain for heparin sodium in 5% dextrose solutions has faced challenges, particularly due to manufacturing delays. Companies like Hospira have experienced long-term backorders for certain concentrations of heparin sodium premixed bags, such as the 12,500 unit/250 mL and 25,000 unit/250 mL in 5% dextrose solutions. These delays are attributed to manufacturing issues, which can impact the financial performance of the companies involved and the overall market availability of the drug[3].

Regulatory Environment

The regulatory environment plays a significant role in the market dynamics of heparin sodium. The FDA closely monitors the production and distribution of heparin sodium solutions, ensuring compliance with safety and efficacy standards. Any changes in regulatory requirements or inspections can affect production and availability, thereby influencing the financial trajectory of the drug. For instance, the FDA's guidelines on the use of plastic containers and the leaching of chemical components from these containers must be strictly adhered to[4].

Competitive Landscape

The market for heparin sodium in 5% dextrose solutions is competitive, with several major players including Pfizer, Baxter, and BBraun. Each of these companies offers various concentrations and formulations of heparin sodium, which can impact pricing and market share. The availability of products from different manufacturers can mitigate the effects of supply chain disruptions but also introduces competition that can affect pricing strategies and revenue[2][3].

Pricing and Revenue

The pricing of heparin sodium in 5% dextrose solutions can be influenced by several factors, including production costs, market demand, and competition. Given the essential nature of the drug, prices tend to be relatively stable, but they can fluctuate based on supply chain disruptions and changes in the competitive landscape. Revenue for companies producing this drug is generally consistent due to the steady demand, but it can be impacted by manufacturing delays and regulatory issues.

Financial Performance

The financial performance of companies producing heparin sodium in 5% dextrose solutions is closely tied to their ability to maintain a stable supply chain and comply with regulatory requirements. Manufacturing delays, as seen with Hospira, can lead to lost revenue and increased costs associated with resolving these issues. On the other hand, companies that can maintain a reliable supply chain and adapt to regulatory changes are likely to see more stable financial performance.

Impact of Shortages

Shortages of heparin sodium premixed bags, such as those experienced by Hospira, can have significant financial implications. These shortages can lead to lost sales and increased costs for expedited shipping or alternative manufacturing arrangements. Additionally, shortages can drive up costs for healthcare providers who may need to source alternative products or manage the shortage through rationing, which can further impact the financial trajectory of the drug[3].

Storage and Handling

The storage and handling requirements for heparin sodium in 5% dextrose solutions also play a role in the market dynamics. These solutions must be stored at controlled room temperatures (20°C to 25°C or 68°F to 77°F) and protected from freezing. Compliance with these storage conditions is crucial to maintain the efficacy and safety of the drug, and any failure to do so can result in financial losses due to product spoilage or recalls[2].

Safety and Efficacy

The safety and efficacy of heparin sodium in 5% dextrose solutions are critical factors in their market dynamics. The drug must be used carefully to avoid complications such as heparin-induced thrombocytopenia (HIT) and heparin-induced thrombotic thrombocytopenia (HITT). The risk of these complications can affect prescribing patterns and patient outcomes, thereby influencing the financial performance of the drug. For example:

"Heparin therapy may then be discontinued without tapering. However, patients presenting with thrombocytopenia or thrombosis after discontinuation of heparin should be evaluated for HIT and HITT"[1].

Market Trends

Current market trends indicate a continued demand for heparin sodium in 5% dextrose solutions, driven by the ongoing need for anticoagulation in various medical procedures. However, the market is also seeing advancements in alternative anticoagulants, which could potentially impact the long-term demand for heparin sodium.

Key Takeaways

• Stable Demand: The demand for heparin sodium in 5% dextrose solutions remains steady due to its essential role in anticoagulation.
• Supply Chain Challenges: Manufacturing delays and supply chain disruptions can significantly impact the availability and financial performance of the drug.
• Regulatory Compliance: Strict adherence to FDA guidelines is crucial for maintaining market presence.
• Competitive Landscape: Multiple major players compete in the market, influencing pricing and revenue.
• Safety and Efficacy: Careful use is necessary to avoid complications like HIT and HITT, which can affect market dynamics.

FAQs

1. What are the common concentrations of heparin sodium in 5% dextrose solutions?

   • Common concentrations include 4,000, 5,000, 10,000, 12,500, and 25,000 USP Units per 100 mL or 250 mL solutions[1][2].

2. What are the storage requirements for heparin sodium in 5% dextrose solutions?

   • These solutions must be stored at controlled room temperatures (20°C to 25°C or 68°F to 77°F) and protected from freezing[2].

3. What are the potential complications associated with heparin sodium therapy?

   • Potential complications include heparin-induced thrombocytopenia (HIT) and heparin-induced thrombotic thrombocytopenia (HITT)[1].

4. Why are there shortages of heparin sodium premixed bags?

   • Shortages are often due to manufacturing delays and supply chain disruptions[3].

5. How does the competitive landscape affect the market for heparin sodium in 5% dextrose solutions?

   • The presence of multiple major players influences pricing and revenue, with companies competing to maintain market share and ensure a stable supply chain[2][3].

Sources

1. Heparin Sodium in 5% Dextrose Injection - FDA Label[1]
2. Heparin Sodium in 5% Dextrose Injection - Pfizer Medical Information[2]
3. Drug Shortage Detail: Heparin Sodium Premixed Bags - ASHP[3]
4. Heparin Sodium in 5% Dextrose Injection - FDA Label[4]