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:	18
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
Piotr Czempik	PHASE4
Imperial College London	Phase 4
Xijing Hospital	Phase 2/Phase 3

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	020287-009	May 1, 2007		RX	Yes	No
Pfizer	FRAGMIN	dalteparin sodium	INJECTABLE;INJECTION	020287-008	Apr 4, 2002		DISCN	No	No
Pfizer	FRAGMIN	dalteparin sodium	INJECTABLE;SUBCUTANEOUS	020287-010	May 1, 2007		RX	Yes	No
Pfizer	FRAGMIN	dalteparin sodium	INJECTABLE;SUBCUTANEOUS	020287-011	May 1, 2007		RX	Yes	No
Pfizer	FRAGMIN	dalteparin sodium	INJECTABLE;SUBCUTANEOUS	020287-005	Apr 4, 2002		RX	Yes	No
Pfizer	FRAGMIN	dalteparin sodium	INJECTABLE;SUBCUTANEOUS	020287-007	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

Market Dynamics and Financial Trajectory for Dalteparin Sodium

Last updated: February 16, 2026

Dalteparin sodium, a low molecular weight heparin (LMWH), is an anticoagulant primarily used in the prevention and treatment of deep vein thrombosis (DVT), pulmonary embolism (PE), and acute coronary syndromes. Its market involves key players, competitive landscape, regulatory environment, and revenue projections.

Market Overview

The global dalteparin sodium market has experienced steady growth since its initial approval, driven by rising incidences of thromboembolic disorders, expanding aging populations, and increasing adoption of anticoagulants in surgical and medical settings. The drug's patent expiry, formulation advancements, and competitive pressures influence market size and revenue streams.

Market Size and Growth

Market estimates suggest that the global LMWH market, which includes dalteparin sodium, exceeded USD 6 billion in 2022. Dalteparin currently holds a significant share within this segment, estimated at approximately 20-25%. Compound annual growth rate (CAGR) forecasts range from 6% to 8% over the next five years, driven by:

• Rising DVT and PE incidences globally.
• Favorable guidelines supporting anticoagulant therapies.
• Increased usage in outpatient settings.

Key Players and Market Share

Major manufacturers producing dalteparin sodium include:

Company	Approximate Market Share (2022)	Notes
Pfizer (GEMZAR)	35-40%	Leading supplier; owns the original patent in the US
BD (Becton Dickinson)	20-25%	Produces biosimilars; expanding portfolio
Other Manufacturers	35-40%	Includes Mylan, biotech firms developing generics

Note: The market share data encompasses regional variations, with Pfizer maintaining dominance in the US, while biosimilar producers command more in Europe and emerging markets.

Regulatory Environment

Regulatory pathways influence market access and financial trajectories. In the US, dalteparin sodium has gained FDA approval, sustaining its premium pricing. The expiration of primary patents has facilitated biosimilar entry, pressuring prices and margins. The European Medicines Agency (EMA) has approved biosimilar versions, fostering competitive pricing dynamics.

Patent Expiry and Biosimilar Competition

Patent expiration timelines:

Patent Date	Biosimilar Entry Expected
US Patent: 2024	Yes, with several biosimilar candidates in late-stage approval
EU Patent: 2023	Multiple biosimilars launched in 2022-2023

Biosimilars typically reduce the cost of therapy by 20-40%, impacting revenue streams for originators like Pfizer.

Revenue Projections and Financial Trajectory

Pfizer's dalteparin sodium segment generated approximately USD 700 million in 2022. Post patent expiry, revenue is projected to decline at a CAGR of around -4% to -6% due to biosimilar competition. Conversely, biosimilar manufacturers are expected to expand market share, capturing 40-50% of the original product's revenue potential within five years of biosimilar market entry.

Forecasts for the broader LMWH market suggest revenues will stabilize around USD 8-10 billion globally by 2027, with dalteparin’s share decreasing but remaining relevant in specific niches like oncology and surgery.

Strategic Factors Impacting Financial Trajectory

• Pricing pressures: Biosimilars erode pricing leeway, impacting profit margins.
• Market penetration: Geographic expansion into emerging markets sustains revenue growth.
• Regulatory approvals: Streamlined approvals for biosimilars can accelerate market share gains.

Future Outlook

The dalteparin sodium market is poised for moderate contraction in developed regions due to biosimilar competition but may see growth opportunities in emerging markets and niche segments. R&D investments targeting improved delivery, new indications, or biosimilar development can offset revenue declines.

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Key Takeaways

• Dalteparin sodium is a core product within the LMWH market, valued at over USD 6 billion globally (2022).
• Pfizer dominates with approximately 35-40% market share; biosimilar firms are expanding.
• Patent expiries from 2023-2024 will likely reduce revenue significantly, with biosimilars expected to capture a sizable market share.
• The global LMWH market is forecasted to reach USD 8-10 billion by 2027, with dalteparin’s revenues declining in developed markets but maintaining relevance elsewhere.
• Competitive pricing and biosimilar entry are the primary drivers of future market dynamics.

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FAQs

1. How does biosimilar entry impact dalteparin sodium revenues?
Biosimilar entry typically reduces prices by 20-40%, leading to revenue declines for the original manufacturer. Biosimilars gain market share rapidly, especially in regions with favorable regulatory environments.

2. What are the main markets for dalteparin sodium?
North America and Western Europe are major markets with high adoption rates. Emerging markets in Asia, Latin America, and the Middle East show growing demand driven by increasing thromboembolic events.

3. Are there new indications for dalteparin sodium?
Research explores additional uses, such as in cancer-related thrombosis and COVID-19-related coagulopathy, which could influence its market trajectory.

4. What strategies do companies use to sustain revenue post-patent expiry?
Investing in biosimilar development, expanding geographic presence, and diversifying indications serve as primary tactics.

5. How do regulatory policies influence market prospects?
Clear pathways and expedited approval processes for biosimilars promote competition, which affects pricing and revenue potential.

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References

1. MarketsandMarkets. "Low Molecular Weight Heparins Market." 2022.
2. Pfizer Annual Report 2022.
3. European Medicines Agency. "Biosimilar Guidelines," 2023.
4. IQVIA. "Global Biopharma Market Insights," 2022.
5. U.S. Food and Drug Administration (FDA). "Biosimilar Development and Approval," 2023.