HEPARIN SODIUM - Generic Drug Details

What are the generic drug sources for heparin sodium and what is the scope of freedom to operate?

Heparin sodium is the generic ingredient in forty-one branded drugs marketed by Hospira, Intl Medication, Luitpold, Parke Davis, Smith And Nephew, Solopak, Abraxis Pharm, Aspen Global Inc, B Braun Medical Inc, Be Pharms, Casi Pharms Inc, Chamberlin Parenterl, Dell Labs, Dr Reddys, Epic Pharma Llc, Fresenius Kabi Usa, Gland, Hikma, Hospira Inc, Lilly, Mylan Labs Ltd, Nanjing King-friend, Pfizer, Pharm Spec, Pharmacia And Upjohn, Sagent Pharms, Sandoz, Shenzhen Techdow, Watson Labs Inc, Baxter Hlthcare, Mcgaw, B Braun, Pharma Serve Ny, 3M, and Cormedix, and is included in eighty-seven NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are forty-nine drug master file entries for heparin sodium. Twenty-two suppliers are listed for this compound.

Summary for HEPARIN SODIUM

US Patents:	4
Tradenames:	41
Applicants:	35
NDAs:	87
Drug Master File Entries:	49
Finished Product Suppliers / Packagers:	22
Clinical Trials:	98
Drug Prices:	Drug price trends for HEPARIN SODIUM
What excipients (inactive ingredients) are in HEPARIN SODIUM?	HEPARIN SODIUM excipients list
DailyMed Link:	HEPARIN SODIUM at DailyMed

See drug prices for HEPARIN SODIUM

Recent Clinical Trials for HEPARIN SODIUM

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 clinical trials

Pharmacology for HEPARIN SODIUM

Drug Class

Anti-coagulant Unfractionated Heparin

Anatomical Therapeutic Chemical (ATC) Classes for HEPARIN SODIUM

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

C05BA	Heparins or heparinoids for topical use
C05B	ANTIVARICOSE THERAPY
C05	VASOPROTECTIVES
C	Cardiovascular system

S01XA	Other ophthalmologicals
S01X	OTHER OPHTHALMOLOGICALS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for HEPARIN SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
3m	LIPO-HEPIN	heparin sodium	INJECTABLE;INJECTION	017027-009	Approved Prior to Jan 1, 1982		DISCN	No	No
Shenzhen Techdow	HEPARIN SODIUM	heparin sodium	INJECTABLE;INJECTION	203198-001	Jun 12, 2014	AP	RX	No	No
Hospira	HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	heparin sodium	INJECTABLE;INJECTION	019339-004	Mar 27, 1985	AP	RX	No	No
Solopak	HEPARIN LOCK FLUSH	heparin sodium	INJECTABLE;INJECTION	087903-001	Apr 20, 1983		DISCN	No	No
Hospira	HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	heparin sodium	INJECTABLE;INJECTION	018916-010	Jun 23, 1989	AP	RX	Yes	Yes
Parke Davis	HEPARIN SODIUM	heparin sodium	INJECTABLE;INJECTION	017346-004	Approved Prior to Jan 1, 1982		DISCN	No	No

HEPARIN SODIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Heparin Sodium

Introduction to Heparin Sodium

Heparin sodium is a widely used anticoagulant, crucial in the prevention and treatment of thromboembolic events, particularly those linked to cardiovascular disorders. The market for heparin sodium is experiencing significant growth, driven by several key factors.

Global Market Size and Forecast

The global heparin sodium market was valued at USD 5.76 billion in 2024 and is projected to reach USD 9.72 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 4.2% during the forecast period of 2024-2031[1].

Market Drivers

Rising Prevalence of Cardiovascular Diseases

The increasing prevalence of cardiovascular diseases worldwide is a major driver for the heparin sodium market. As cardiovascular diseases rise, so does the demand for anticoagulants like heparin sodium to prevent and treat associated thromboembolic events[1].

Advancements in Drug Delivery and Production

Ongoing developments in drug delivery methods and pharmaceutical production processes are enhancing the safety and effectiveness of heparin sodium formulations. These advancements are improving patient outcomes and product quality, thereby propelling market growth[1].

Growing Healthcare Expenditure

Increasing healthcare spending, especially in emerging nations, is making modern medical therapies like heparin sodium more accessible. This trend is expected to support market expansion in these regions[1].

Regulatory Support and Approval

Strict regulatory guidelines governing the usage and production of pharmaceuticals like heparin sodium ensure the safety and quality of the final product. Regulatory approvals for new formulations and indications further aid market growth[1].

Increase in R&D Efforts

Companies are investing heavily in research and development to improve heparin sodium formulations and expand their applications, which is a significant driver for the market[1].

Market Restraints

Safety Concerns

Heparin-induced thrombocytopenia (HIT) and allergic reactions are adverse events associated with heparin sodium, which can reduce its usage, especially in specific patient populations[1].

Price Volatility

Changes in the cost of raw materials, such as pig mucosa, used in the manufacturing of heparin sodium can impact manufacturers' profit margins and market pricing[1].

Competition from Generic Manufacturers

The expiration of patents on some heparin sodium formulations has led to increased competition from generic manufacturers, which can limit the revenue potential for branded products and drive down prices[1].

Regional Analysis

North America

North America is expected to hold the largest market share during the forecast period. The presence of significant players and increased investments in research and development are key factors driving market growth in this region[1].

Europe, Asia Pacific, and Rest of the World

Other regions, including Europe, Asia Pacific, and the rest of the world, are also experiencing growth due to increasing healthcare expenditures and the rising prevalence of cardiovascular diseases[1].

Key Players and Market Strategies

Major Companies

Companies such as Pfizer Inc., Aspen Pharmacare Holdings Limited, Leo Pharma A-S, Sanofi, and others are profiled in the market. These companies are focusing on enhancing their product portfolios through technological advancements and strategic investments[2].

Qilian International's Strategic Pivot

Qilian International, for instance, is adjusting its industrial investments by reducing focus on oxytetracycline and increasing investment in heparin sodium. This move is driven by the high demand for heparin sodium in medical applications and the declining market for oxytetracycline[5].

Financial Trajectory

Revenue Projections

The global heparin sodium market is expected to grow significantly, with revenue projections indicating a substantial increase from USD 5.76 billion in 2024 to USD 9.72 billion by 2031[1].

CAGR and Growth Rate

The market is growing at a CAGR of 4.2% during the forecast period, which is a robust growth rate driven by the factors mentioned above[1].

Regional Revenue Contributions

North America is anticipated to contribute the largest share to the global revenue, followed by Europe, Asia Pacific, and the rest of the world. The increasing healthcare expenditures and the presence of major players in these regions are key contributors to this growth[1].

Market Opportunities and Challenges

Opportunities

• Expanding Healthcare Needs: The growing demand for healthcare services globally, especially in emerging markets, presents a significant opportunity for the heparin sodium market.
• Technological Advancements: Continuous improvements in drug delivery and production processes offer opportunities for innovation and market expansion.
• Diversification: Companies can diversify their product lines to include other anticoagulants and related medical products, reducing dependency on a single product[1][2].

Challenges

• Regulatory Hurdles: Strict regulatory guidelines can pose challenges for new entrants and existing players in terms of compliance and approval.
• Raw Material Volatility: Fluctuations in the cost of raw materials can impact production costs and profitability.
• Safety Concerns: Managing and mitigating safety concerns such as HIT and allergic reactions is crucial for maintaining market trust and growth[1].

Conclusion

The heparin sodium market is poised for significant growth driven by increasing healthcare needs, advancements in technology, and regulatory support. However, it also faces challenges such as safety concerns, price volatility, and competition from generic manufacturers. Companies like Qilian International are strategically pivoting to capitalize on the high demand for heparin sodium, indicating a promising financial trajectory for the market.

Key Takeaways

• The global heparin sodium market is projected to reach USD 9.72 billion by 2031.
• The market is driven by the rising prevalence of cardiovascular diseases and advancements in drug delivery.
• North America is expected to hold the largest market share.
• Safety concerns and price volatility are significant restraints.
• Companies are diversifying their investments to capitalize on the growing demand.

FAQs

What is the projected market size of the global heparin sodium market by 2031?

The global heparin sodium market is projected to reach USD 9.72 billion by 2031[1].

What are the main drivers of the heparin sodium market?

The main drivers include the rising prevalence of cardiovascular diseases, advancements in drug delivery and production, growing healthcare expenditure, and regulatory support[1].

Which region is expected to hold the largest market share in the heparin sodium market?

North America is expected to hold the largest market share during the forecast period[1].

What are the significant restraints facing the heparin sodium market?

Significant restraints include safety concerns such as HIT and allergic reactions, price volatility of raw materials, and competition from generic manufacturers[1].

How is Qilian International adjusting its strategy in relation to heparin sodium?

Qilian International is reducing its investment in oxytetracycline and increasing its focus on heparin sodium due to its high demand and promising market outlook[5].

Sources

1. Verified Market Research: Heparin Sodium Market Size, Forecast.
2. Market Research Intellect: Heparin (Heparin Sodium and Heparin Calcium) Market Size, Scope.
3. Spherical Insights: United States Heparin Market Size, Share, Forecast to 2033.
4. BioSpace: Heparin Sodium Market Size, Trends, Growth, Report 2022-2030.
5. Stock Titan: Qilian International plans to adjust industrial investment.