DALTEPARIN SODIUM - Generic Drug Details

What are the generic sources for dalteparin sodium and what is the scope of patent protection?

Dalteparin sodium is the generic ingredient in one branded drug marketed by Pfizer and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for dalteparin sodium. One supplier is listed for this compound.

Summary for DALTEPARIN SODIUM

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	17
What excipients (inactive ingredients) are in DALTEPARIN SODIUM?	DALTEPARIN SODIUM excipients list
DailyMed Link:	DALTEPARIN SODIUM at DailyMed

Recent Clinical Trials for DALTEPARIN SODIUM

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

Sponsor	Phase
Imperial College London	Phase 4
Xijing Hospital	Phase 2/Phase 3
PharmaDiall Ltd.	Phase 2

See all DALTEPARIN SODIUM clinical trials

Pharmacology for DALTEPARIN SODIUM

Drug Class

Anti-coagulant Low Molecular Weight Heparin

Medical Subject Heading (MeSH) Categories for DALTEPARIN SODIUM

Anticoagulants

Fibrinolytic Agents

Anatomical Therapeutic Chemical (ATC) Classes for DALTEPARIN SODIUM

B01AB	Heparin group
B01A	ANTITHROMBOTIC AGENTS
B01	ANTITHROMBOTIC AGENTS
B	Blood and blood forming organs

US Patents and Regulatory Information for DALTEPARIN SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	FRAGMIN	dalteparin sodium	INJECTABLE;SUBCUTANEOUS	020287-004	Jan 30, 1998		RX	Yes	No
Pfizer	FRAGMIN	dalteparin sodium	INJECTABLE;SUBCUTANEOUS	020287-001	Dec 22, 1994		RX	Yes	No
Pfizer	FRAGMIN	dalteparin sodium	INJECTABLE;SUBCUTANEOUS	020287-003	Mar 18, 1996		RX	Yes	No
Pfizer	FRAGMIN	dalteparin sodium	INJECTABLE;SUBCUTANEOUS	020287-007	Apr 4, 2002		DISCN	No	No
Pfizer	FRAGMIN	dalteparin sodium	INJECTABLE;SUBCUTANEOUS	020287-011	May 1, 2007		RX	Yes	No
Pfizer	FRAGMIN	dalteparin sodium	INJECTABLE;INJECTION	020287-008	Apr 4, 2002		DISCN	No	No

Expired US Patents for DALTEPARIN SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	FRAGMIN	dalteparin sodium	INJECTABLE;SUBCUTANEOUS	020287-001	Dec 22, 1994	4,303,651
Pfizer	FRAGMIN	dalteparin sodium	INJECTABLE;SUBCUTANEOUS	020287-003	Mar 18, 1996	4,303,651
Pfizer	FRAGMIN	dalteparin sodium	INJECTABLE;SUBCUTANEOUS	020287-004	Jan 30, 1998	4,303,651

DALTEPARIN SODIUM Market Analysis and Financial Projection Experimental

Dalteparin Sodium Market Dynamics and Financial Trajectory

Market Introduction

Dalteparin sodium, a low-molecular-weight heparin (LMWH), is widely used in the prevention and treatment of thrombotic disorders. It is administered to prevent blood vessel complications in patients with angina or heart attacks and to avoid deep vein thrombosis (DVT) and pulmonary embolism[1].

Market Dynamics

Drivers

The dalteparin sodium market is driven by several key factors:

• Growing Prevalence of Chronic Diseases: The increasing incidence of cardiovascular diseases, surgeries, and other conditions that require anticoagulation therapy is a significant driver of the market[1].
• Government Initiatives: Enhanced healthcare facilities and increased research funding contribute to the market's growth. Governments are investing more in healthcare infrastructure, which includes the development and use of anticoagulant medications like dalteparin sodium[1].
• Advantages Over Unfractionated Heparin: Dalteparin sodium offers improved bioavailability, prolonged antithrombotic activity, and the convenience of once-daily administration, making it a preferred choice over unfractionated heparin (UFH)[5].

Restraints

Despite the positive drivers, there are several restraints that affect the market:

• Stringent Regulations: The pharmaceutical industry is heavily regulated, and the approval process for new drugs and formulations can be lengthy and costly. This can slow down the introduction of new products and limit market growth[1].
• Lack of Skilled Personnel: The lack of skilled personnel with the necessary technical knowledge can hinder the production and distribution of dalteparin sodium, particularly in regions with limited healthcare resources[1].

Market Segmentation

The dalteparin sodium market is segmented based on type and application:

• Type: The market is segmented into tablets and injections. However, dalteparin sodium is primarily administered via subcutaneous injection due to its bioavailability and efficacy[1].
• Application: The primary applications include myocardial infarction treatment, hemodialysis, and other indications such as the prevention of deep vein thrombosis and pulmonary embolism[1].

Regional Framework

The market is analyzed across several major regions:

• North America: This region is expected to contribute significantly to the market due to advanced healthcare infrastructure and high demand for anticoagulant therapies.
• Europe: Europe is another key market, driven by a high prevalence of cardiovascular diseases and well-established healthcare systems.
• Asia-Pacific (APAC): The APAC region is expected to show rapid growth due to increasing healthcare spending and a large patient population.
• Middle East and Africa (MEA): This region is also growing, driven by government initiatives to improve healthcare facilities.
• South and Central America: These regions are expected to contribute to the market growth, albeit at a slower pace compared to other regions[1].

Financial Trajectory

Market Size and Growth

The global dalteparin sodium market is projected to grow significantly:

• Current Market Size: The market size was valued at approximately USD 1.2 billion in 2023[4].
• Projected Market Size: It is expected to reach around USD 2.3 billion by 2032, indicating a substantial growth trajectory[4].
• CAGR: The market is forecasted to grow at a CAGR of XX% from 2023 to 2031, reflecting a robust growth rate driven by increasing demand and expanding applications[1].

Cost Effectiveness

Studies have shown that dalteparin sodium is cost-effective, especially in preventing venous thromboembolic events:

• Cost-Utility Analysis: A study indicated that the incremental cost-effectiveness of dalteparin 5000 U over dalteparin 2500 U and UFH was approximately US$23,799 and US$21,779 per QALY gained, respectively. This suggests that higher doses of dalteparin can be cost-effective in certain clinical scenarios[2].

Key Players

The market is dominated by several key players:

• Aspen Oss
• Changzhou Qianhong Bio-pharma
• Dongcheng Biochemicals
• Dongying Tiandong Pharmaceutical
• Opocrin
• Pfizer
• Shenzhen Hepalink
• Sichuan Deebio Pharmaceutical Co., Ltd.
• Xinbai Pharmaceuticals
• Yino Pharma Limited[1].

Industry Landscape and Competition

The industry landscape is characterized by intense competition and continuous innovation:

• Research and Development: Companies are focusing on research and development to improve the efficacy and safety of dalteparin sodium formulations.
• Regulatory Approvals: Obtaining regulatory approvals is crucial for market entry, and companies are investing heavily in this process.
• Market Expansion: Key players are expanding their market presence through strategic partnerships and acquisitions[1].

Future Trends

The market is expected to be influenced by several future trends:

• Increasing Demand for Anticoagulants: The growing prevalence of cardiovascular diseases and the need for effective anticoagulation therapies will drive the demand for dalteparin sodium.
• Advancements in Healthcare: Improvements in healthcare infrastructure and the adoption of advanced medical technologies will further boost the market.
• Government Initiatives: Continued government support for healthcare and research will play a crucial role in the market's growth[1].

Key Takeaways

• The dalteparin sodium market is driven by the growing prevalence of chronic diseases and government initiatives to enhance healthcare facilities.
• The market is segmented by type (tablets and injections) and application (myocardial infarction treatment, hemodialysis, etc.).
• Key players include Aspen Oss, Pfizer, and Shenzhen Hepalink, among others.
• The market is expected to grow significantly, with a projected size of USD 2.3 billion by 2032.
• Dalteparin sodium has been shown to be cost-effective in preventing venous thromboembolic events.

FAQs

1. What is the primary use of dalteparin sodium? Dalteparin sodium is primarily used to prevent blood vessel complications in people with certain types of angina or heart attack and to avoid deep vein thrombosis (DVT) and pulmonary embolism[1].

2. What are the key drivers of the dalteparin sodium market? The key drivers include the growing prevalence of chronic diseases, government initiatives to enhance healthcare facilities, and the advantages of dalteparin sodium over unfractionated heparin[1].

3. Which regions are expected to contribute significantly to the dalteparin sodium market? North America, Europe, and the Asia-Pacific region are expected to be the major contributors to the market growth due to their advanced healthcare infrastructure and high demand for anticoagulant therapies[1].

4. What is the projected market size of dalteparin sodium by 2032? The global dalteparin sodium market is projected to reach around USD 2.3 billion by 2032[4].

5. Who are the key players in the dalteparin sodium market? Key players include Aspen Oss, Changzhou Qianhong Bio-pharma, Pfizer, Shenzhen Hepalink, and Sichuan Deebio Pharmaceutical Co., Ltd., among others[1].

Sources

1. The Insight Partners - Dalteparin Sodium Market Key Players Analysis 2031
2. PubMed - Cost effectiveness of dalteparin for preventing venous thromboembolism
3. Business Research Insights - Enoxaparin Sodium Market Size, Share, Growth To 2032
4. Dataintelo - Dalteparin Sodium API Market Research Report 2032
5. PubMed - Dalteparin sodium