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
Western University, Canada	Phase 3
Valeo Pharma Inc	Phase 3
Itreas	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
Pfizer	FRAGMIN	dalteparin sodium	INJECTABLE;SUBCUTANEOUS	020287-007	Apr 4, 2002		DISCN	No	No
Pfizer	FRAGMIN	dalteparin sodium	INJECTABLE;SUBCUTANEOUS	020287-009	May 1, 2007		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

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	4,303,651
Pfizer	FRAGMIN	dalteparin sodium	INJECTABLE;SUBCUTANEOUS	020287-004	Jan 30, 1998	4,303,651
Pfizer	FRAGMIN	dalteparin sodium	INJECTABLE;SUBCUTANEOUS	020287-003	Mar 18, 1996	4,303,651

International Patents for FRAGMIN

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

Country	Patent Number	Title	Estimated Expiration
U.S.S.R.	1209033	"CПOCOБ ПOЛУЧEHИЯ ДEПOЛИMEPИЗOBAHHOГO ГEПAPИHA" (METHOD OF PRODUCING DEPOLYMERIZED HEPARIN)
Germany	3068924
Denmark	160764
Norway	150801
Japan	S56500066
Japan	S6344764
World Intellectual Property Organization (WIPO)	8001383

Market Dynamics and Financial Trajectory for FRAGMIN (Dalteparin Sodium)

Last updated: July 30, 2025

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Introduction

FRAGMIN, the brand name for dalteparin sodium, is a low-molecular-weight heparin (LMWH) primarily utilized for anticoagulation in various clinical settings. As a critical agent in thrombosis prevention, it has held a significant position within the anticoagulant market for decades. This analysis explores the current market dynamics, competitive landscape, and financial trajectory shaping FRAGMIN’s future impact and positioning.

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Market Overview: The Anticoagulant Landscape

The global anticoagulant market continues to expand driven by rising incidences of thrombotic disorders, increasing prevalence of cardiovascular diseases, and expanding indications for anticoagulant therapies. The COVID-19 pandemic further accelerated demand for anticoagulants due to heightened thrombotic complications among severe cases.

The LMWH segment, which includes FRAGMIN, accounts for a substantial portion of the anticoagulant market owing to its efficacy, favorable bleeding profile, and convenience in administration (subcutaneous injection). Notably, LMWHs represent an alternative to unfractionated heparin, with growing preference among clinicians for their predictable pharmacokinetics.

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Market Dynamics Impacting FRAGMIN

1. Competition and Market Share

FRAGMIN faces competition from several LMWH brands, notably Clexane (enoxaparin) and Arixtra (fondaparinux). In the United States, Fresenius Kabi and Sandoz have developed biosimilars, intensifying price competition. The advent of biosimilars, characterized by lower prices and increased accessibility, challenges the market dominance of branded formulations like FRAGMIN.

In Europe and other regions, regulatory approvals for generic equivalents are pending or underway, potentially reducing profitability for original brands. The competitive landscape influences market share retention and necessitates strategic pricing and distribution adjustments.

2. Regulatory Environment and Patent Landscape

FRAGMIN’s patent protections have expired or are nearing expiry in several key markets, exposing the drug to biosimilar entry. Regulatory authorities continue to scrutinize biosimilarity and interchangeability criteria, shaping market entry timing for competitors.

Post-launch regulatory incentives and fast-track approvals for biosimilars accelerate the commoditization of LMWHs, with potential pricing pressures and margin erosion for original formulations like FRAGMIN.

3. Clinical Adoption and Prescribing Trends

Clinical guidelines increasingly favor LMWHs over unfractionated heparin owing to improved safety profiles, predictable responses, and convenient administration. For FRAGMIN, this translates into steady demand. However, clinicians’ preference for cost-effective biosimilars could diminish stewardship of branded drugs unless differentiation is justified through extensive clinical data or novel formulations.

4. Regional and Demographic Factors

Emerging markets, including Asia-Pacific and Latin America, exhibit rising demand due to expanding healthcare infrastructure and improved diagnostics. In these regions, pricing flexibility and local manufacturing are critical for growth.

In contrast, regulatory complexities, reimbursement policies, and market access hurdles in developed countries influence revenue streams and accelerate biosimilar penetration.

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Financial Trajectory

1. Revenue Projections

The revenue outlook for FRAGMIN hinges on biosimilar competition, regional demand, and pricing strategies:

• Peak Revenue Scenario: In markets where biosimilars are delayed or restricted, FRAGMIN may sustain moderate revenues through continued demand for standard indications such as deep vein thrombosis (DVT) prophylaxis and cancer-associated thrombosis.

• Downward Pressure: Biosimilar entry is expected to reduce average selling prices (ASPs) by 30–50%, impacting margins. The shift could lead to a decline in global sales growth, especially in Europe and the US.

2. Cost Structure and Profitability

Manufacturing costs for biologics like FRAGMIN are substantial, involving complex purification and quality assurance processes. Introduction of biosimilars, which often have lower production costs, may compress profit margins unless strategic improvements or diversification are implemented.

Research and development (R&D) expenditures focus on improving formulations, developing novel indications, or biosimilar development, impacting overall financial health.

3. Strategic Initiatives and Revenue Diversification

Partnerships with generic and biosimilar manufacturers can expand reach. Moreover, expanding indications—such as cancer-associated thrombosis or other off-label uses—can mitigate revenue losses from biosimilar competition.

Clinical trial investments into novel, more soluble or convenient formulations could provide premium positioning, enhancing long-term financial trajectories.

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Market Drivers Accelerating Growth

• Increasing Thrombotic Disorders: Aging populations and lifestyle-related diseases contribute to rising thrombotic event incidences.
• Regulatory Approvals of Biosimilars: Streamline entry, reduce prices, and increase accessibility.
• Expanding Use in Oncology and COVID-19: Anticoagulation's role in managing COVID-19-related coagulopathies reinforces demand.
• Healthcare Infrastructure Expansion in Emerging Markets: Enhanced access supports future sales growth.

Market Restraints and Challenges

• Intense Biosimilar Competition: Accelerates price erosion.
• Regulatory Barriers and Patent Expirations: Delay or limit revenue streams.
• Pricing Pressures and Reimbursement Constraints: Especially in value-based healthcare environments.
• Clinical Preference Shifts: Towards oral anticoagulants like direct oral anticoagulants (DOACs), which reduce the demand for injectable LMWHs.

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Conclusion

The future financial trajectory of FRAGMIN is characterized by a delicate balance between persistent clinical demand and looming biosimilar competition. While current market dynamics favor continued usage in specific indications, the proliferation of biosimilars and evolving clinical practices will challenge its profitability. Strategic positioning through innovation, indication expansion, and geographic diversification remains essential for maintaining revenue streams in a highly competitive environment.

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Key Takeaways

• The global anticoagulant market, especially LMWHs like FRAGMIN, remains sizable yet highly competitive, with biosimilars rapidly gaining market share.
• Patent expirations and regulatory ease for biosimilars portend pricing pressures and margins compression.
• Demand persistence is driven by clinical guidelines favoring LMWHs and expanding indications, notably in oncology and COVID-19 management.
• Future growth hinges on strategic differentiation, geographic expansion, and innovation efforts.
• Companies should monitor regulatory developments, biosimilar entry timelines, and shifting clinician preferences, all of which directly impact FRAGMIN’s financial outlook.

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FAQs

1. How does biosimilar competition influence FRAGMIN’s market share?
Biosimilars typically enter markets with significantly lower prices, leading to rapid erosion of FRAGMIN’s market share unless differentiated by clinical advantages or strategic relationships.

2. What are the primary regulatory challenges for maintaining revenue?
Patent expirations and the ease of biosimilar approval threaten exclusivity; regulatory requirements for biosimilar equivalence prolong market entry and could reduce pricing premiums.

3. Which indications are driving demand for FRAGMIN?
DVT prophylaxis, cancer-associated thrombosis, and complications related to COVID-19 are primary indications maintaining demand levels.

4. How are emerging markets influencing the financial outlook?
Growing healthcare investments and increasing thrombotic disease prevalence bolster demand, offering revenue opportunities despite price sensitivity.

5. What strategic steps can preserve FRAGMIN’s viability amid biosimilar entry?
Investing in formulation innovation, expanding indications, entering partnerships, and optimizing regional distribution can help mitigate the impact of biosimilar competition.

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Sources
[1] MarketWatch. "Global Anticoagulant Drugs Market Analysis." 2022.
[2] Grand View Research. "Low Molecular Weight Heparin Market Size, Share & Trends." 2023.
[3] FDA. "Biosimilar and Interchangeable Products." 2022.
[4] EvaluatePharma. "Pharmaceutical Market Outlook." 2023.