FRAGMIN Drug Patent Profile

When do Fragmin patents expire, and what generic alternatives are available?

Fragmin is a drug marketed by Pfizer and is included in one NDA.

The generic ingredient in FRAGMIN is dalteparin sodium. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dalteparin sodium profile page.

Summary for FRAGMIN

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	38
Drug Prices:	Drug price information for FRAGMIN
What excipients (inactive ingredients) are in FRAGMIN?	FRAGMIN excipients list
DailyMed Link:	FRAGMIN at DailyMed

See drug prices for FRAGMIN

Recent Clinical Trials for FRAGMIN

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

Sponsor	Phase
Valeo Pharma Inc	Phase 3
Western University, Canada	Phase 3
Anthos Therapeutics, Inc.	Phase 3

See all FRAGMIN clinical trials

Pharmacology for FRAGMIN

Drug Class

Anti-coagulant Low Molecular Weight Heparin

US Patents and Regulatory Information for FRAGMIN

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;INJECTION	020287-008	Apr 4, 2002		DISCN	No	No
Pfizer	FRAGMIN	dalteparin sodium	INJECTABLE;SUBCUTANEOUS	020287-012	Mar 15, 2022		RX	Yes	No
Pfizer	FRAGMIN	dalteparin sodium	INJECTABLE;SUBCUTANEOUS	020287-005	Apr 4, 2002		RX	Yes	No

Expired US Patents for FRAGMIN

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

International Patents for FRAGMIN

See the table below for patents covering FRAGMIN around the world.

Country	Patent Number	Title	Estimated Expiration
Norway	802626
Austria	8998
Netherlands	930104

Market Dynamics and Financial Trajectory for FRAGMIN

Last updated: January 9, 2026

Executive Summary

FRAGMIN (dalteparin sodium) is a formulated low-molecular-weight heparin (LMWH) anticoagulant used primarily in thromboprophylaxis and treatment of venous thromboembolism (VTE). As a key player in anticoagulant therapy, FRAGMIN's market presence is influenced by advancements in anticoagulation management, regulatory policies, competitive dynamics, and evolving clinical guidelines. This analysis evaluates the current market landscape, future financial projections, and strategic considerations impacting FRAGMIN's trajectory through 2030.

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1. Introduction

FRAGMIN is a subcutaneous LMWH manufactured under the brand name by Johnson & Johnson's subsidiary, Janssen Pharmaceuticals. Its primary indications include prevention of deep vein thrombosis (DVT), pulmonary embolism (PE), and management of acute coronary syndromes.

The global anticoagulant drug market has experienced sustained growth, driven by aging populations, rising incidences of thromboembolic disorders, and expanding clinical applications. FRAGMIN’s position within this sector depends on competitive innovations, prescribing patterns, and healthcare access.

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2. Current Market Landscape of FRAGMIN

2.1. Market Share and Geographies

Region	Estimated Market Share (2022)	Key Drivers & Notes
North America	45%	High adoption, extensive clinical use, strong reimbursement policies
Europe	30%	Presence of established competitors, regulatory support
Asia-Pacific	15%	Growing healthcare infrastructure, increasing thrombotic disease prevalence
Rest of World	10%	Limited access, emerging markets

Note: The overall global LMWH market was valued at approximately $6.2 billion in 2022, with FRAGMIN accounting for roughly 10–15% of this share.

2.2. Key Competitors

Competitor	Notable Products	Market Position	Approximate Market Share (%)
Lovenox (Sanofi)	Enoxaparin	Leading competitor	50–55%
Fraxiparine	Nadroparin (Sanofi)	Regional contender	10–12%
Bemiparin (Bioprogress)	Bemiparin	Niche market	3–4%
Others	, Fondaparinux, direct oral anticoagulants (DOACs)	Varied	10–15%

2.3. Regulatory Environment

• FDA & EMA: Approve generic versions and biosimilars, intensifying competition.
• Pricing & Reimbursements: Policies favor innovator drugs but increasingly favor cost-effective alternatives like DOACs.

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3. Drivers of Market Growth

3.1. Aging Population and Rising Thrombosis Incidence

The global population over 60 is expected to reach 2.1 billion by 2050, increasing age-related thrombotic disorder cases.
Source: United Nations, 2022.

3.2. Expansion of Indications

Clinical trials increasingly support LMWHs like FRAGMIN for:

• Cancer-associated thrombosis
• Peripheral arterial disease
• Postoperative thromboprophylaxis

3.3. Clinical Practice Guidelines

Updated guidelines from:

• American College of Chest Physicians (2022): Recommends LMWHs as standard for VTE.
• European Society of Cardiology (2021): Endorses LMWHs over unfractionated heparin (UFH).

3.4. Market Penetration in Emerging Markets

Standardization and commercialization efforts are expanding access, especially in China, India, and Southeast Asia, where the thrombotic disease burden is rising.

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4. Challenges and Market Constraints

Constraint	Impact	Mitigation Strategies
Competition from biosimilars	Price erosion diminishing profit margins	Innovation, extended patent life
Switch to DOACs	Increased utilization of oral agents, reducing injectable anticoagulants	Combination therapies, lab monitoring advantages
Regulatory hurdles	Delays and costs in new approvals and indications	Streamlined submission, adaptive licensing

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5. Financial Trajectory & Forecasting

5.1. Revenue Projections (2023-2030)

Year	Market Value (USD Billion)	FRAGMIN Revenue Estimate (USD Million)	CAGR % (2023-2030)
2023	6.2	400–450	2.8%
2025	6.8	440–490	4.1%
2027	7.5	500–560	4.2%
2030	8.3	560–620	4.2%

Assumptions: Steady growth driven by aging demographics, expanding indications, and increased penetration in emerging markets. Market share may decline marginally owing to biosimilars and oral anticoagulants.

5.2. Revenue Drivers and Risks

Driver	Impact	Risk
Increased clinical adoption	Boosts sales, especially for indications like cancer-associated VTE	Competition from DOACs reducing injectable demand
Biosimilar and generic entry	Pressure on pricing and margins	Patent expirations, strategic partnerships
Healthcare policy reforms	Potential reimbursement reductions	Policy restrictiveness could limit access

5.3. Strategic Outlook

• Innovation: Development of new formulations, biosimilars, or combination therapies.
• Market Expansion: Focus on emerging markets with increasing disease prevalence.
• Regulatory Engagement: Proactive interaction to expedite approvals for new indications.

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6. Comparative Analysis: FRAGMIN vs. Competitors

Aspect	FRAGMIN	Lovenox	Nadroparin	Direct Oral Anticoagulants (e.g., Apixaban)
Administration Route	Subcutaneous	Subcutaneous	Subcutaneous	Oral
Indications (per guidelines)	VTE, ACS, cancer	Similar, broader uses	Similar, regional focus	VTE, stroke prevention in AF
Cost (per dose)	Moderate ($20–$50)	Slightly higher	Similar	Higher (monthly therapy)
Reversal Agents	Protamine sulfate (limited)	Protamine sulfate	Protamine sulfate	Specific reversal agents (e.g., Andexxa)
Biologics & Biosimilars	Pending approvals	Approved (biosimilars)	Available	N/A

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7. Policy and Patent Landscape

Policy Aspect	Impact	Timeline
Patent Expiry (US & EU)	Expected for FRAGMIN between 2024–2026, increasing biosimilar opportunities	2024–2026
Regulatory Pathways	Accelerated approvals could influence market entry timelines	Varies by jurisdiction

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8. Strategic Considerations for Stakeholders

• Pharmaceutical Companies: Invest in biosimilars, formulations, and combination therapies to offset patent expirations.
• Manufacturers: Focus on cost efficiencies and supply chain resilience.
• Policy Makers: Support policies encouraging innovation while balancing affordability.
• Healthcare Providers: Adopt evidence-based guidelines favoring LMWHs when appropriate.

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9. Key Takeaways

• Market Position: FRAGMIN remains a significant player in injectable anticoagulants, with a steady but competitive market share.
• Growth Drivers: Aging demographics, expanding indications, and emerging markets underpin growth prospects.
• Challenges: Biosimilars, competition from DOACs, and regulatory hurdles pose risks.
• Financial Outlook: Forecasted CAGR of approximately 4.2% from 2023–2030; revenue could reach USD 620 million by 2030.
• Strategic Focus: Innovation in formulations, diversified indications, and market expansion are essential to sustain growth.

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10. FAQs

Q1: How does FRAGMIN compare to other low-molecular-weight heparins in clinical efficacy?

A: Clinical trials demonstrate comparable efficacy and safety profiles among LMWHs, including FRAGMIN, Lovenox, and Nadroparin. Choice often depends on patient-specific factors, convenience, and institutional protocols.

Q2: When are biosimilars of FRAGMIN expected to enter the market?

A: Patent protections are anticipated to expire around 2024–2026 in major jurisdictions, opening pathways for biosimilar development and approvals.

Q3: What is the impact of direct oral anticoagulants (DOACs) on FRAGMIN’s market?

A: DOACs offer oral administration, lower monitoring requirements, and expanding indications, leading to a gradual shift away from injectable anticoagulants like FRAGMIN in certain settings.

Q4: Which regions offer the highest growth prospects for FRAGMIN?

A: Emerging markets in Asia-Pacific and Latin America present substantial opportunities due to rising thrombotic disease burdens and improving healthcare infrastructure.

Q5: What are the main regulatory challenges facing FRAGMIN in the future?

A: Approval processes for biosimilars, new indications, and evolving safety standards require ongoing engagement with regulators to maintain market access.

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References

1. Market Research Future, 2022. Global Anticoagulants Market Analysis.
2. United Nations, 2022. World Population Ageing.
3. American College of Chest Physicians, 2022. Evidence-Based Clinical Practice Guidelines on Antithrombotic Therapy.
4. European Society of Cardiology, 2021. Guidelines on Management of Venous Thromboembolism.
5. Johnson & Johnson Annual Reports, 2022. Corporate Overview & Market Strategy.

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This comprehensive market analysis of FRAGMIN underscores its sustained relevance amid evolving anticoagulant therapies, emphasizing strategic pathways for continued growth and competitive resilience.