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

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

International Patents for FRAGMIN

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

Country	Patent Number	Title	Estimated Expiration
Austria	8998
Canada	1136620	FRAGMENTS D'HEPARINE AYANT UNE ACTIVITE ANTICOAGULANTE SELECTIVE (HEPARIN FRAGMENTS HAVING SELECTIVE ANTICOAGULATION ACTIVITY)
Germany	3068924
Denmark	160764
Denmark	380280
European Patent Office	0014184	HEPARIN FRAGMENTS HAVING A SELECTIVE ANTICOAGULATION ACTIVITY AND PROCESS FOR THEIR PREPARATION
Japan	S56500066

Last updated: February 16, 2026

What is the current market landscape for FRAGMIN?

FRAGMIN (dalteparin sodium) is a low molecular weight heparin (LMWH) anticoagulant primarily used to prevent and treat deep vein thrombosis (DVT), pulmonary embolism (PE), and in some cases, for prophylaxis in surgical or bedridden patients. It is marketed globally, with key revenues in North America, Europe, and Asia. The drug faces competitive pressure from biosimilars and alternative anticoagulants like enoxaparin and fondaparinux.

Market size estimates indicate the global LMWH market was valued at approximately $10 billion in 2022, with expected compound annual growth rate (CAGR) of 6% through 2027[1]. FRAGMIN maintains a significant share, especially in indications requiring specific dosage or administration protocols.

How does FRAGMIN's patent status affect its future valuation?

FRAGMIN’s primary patent expired in 2008 in the US, with some compelling patents covering formulation and manufacturing processes extending protection into subsequent years. Patent expirations transitioned the market toward biosimilars, leading to increased competition and price pressure.

In the European Union, patent expirations gradually occurred from 2013 onwards, with some biosimilar approvals granted since then. The presence of biosimilars, such as Clexane (sanofi) and others, has driven down prices by approximately 30-50% in markets where biosimilars are available[2].

Despite patent expirations, secured market segments persist due to physicians' familiarity, established dosing protocols, and patient safety profiles. The complexity of LMWH manufacturing and regulatory approval for biosimilars constrains rapid market penetration, maintaining some premium for originator products.

What are the key drivers and risks influencing FRAGMIN's investment outlook?

Drivers:

• Increasing incidence of thromboembolic disorders due to aging populations and lifestyle factors.
• Growing adoption of anticoagulants for perioperative and outpatient management.
• Continuous improvements in production processes reducing costs and maintaining supply stability.
• Ongoing clinical research exploring expanded indications, such as cardiovascular and cancer-associated thrombosis.

Risks:

• Market shift toward direct oral anticoagulants (DOACs), which offer oral administration, no monitoring, and comparable efficacy.
• Patent expirations and biosimilar entry exert downward pricing pressure.
• Regulatory hurdles regarding biosimilar approvals could delay or limit market penetration.
• Potential for adverse events or safety concerns impacting revenue.

How is the pipeline affecting the valuation and investment potential?

FRAGMIN's manufacturer, generally GlaxoSmithKline (GSK), has not prioritized new formulations or indications; however, ongoing research into biosimilars and formulations could influence future revenues. The pipeline emphasis has shifted toward novel oral anticoagulants (NOACs). This technological shift risks future relevance of injectable LMWHs unless differentiation strategies or niche indications are targeted.

The absence of significant pipeline innovations limits upside potential. Decisively, the current revenue base remains relevant for short- to medium-term stability, but long-term growth prospects rely on market dynamics and regulatory adaptations.

What financial metrics and valuation approaches are relevant?

Financial data is limited due to FRAGMIN being a marketed drug, not a new development asset. Companies typically report revenues from branded and generic LMWH products under broader anticoagulant segments.

Valuations depend on:

• Revenue projections considering market share erosion from biosimilars.
• Cost structure efficiencies and supply chain management.
• Market penetration in emerging regions.
• Potential licensing or partnership deals for biosimilar development.

Applying discounted cash flow (DCF) models requires assumptions about declining revenues due to biosimilar competition, with estimated terminal decline rates of 5%-10% annually over five years.

What strategic actions could influence FRAGMIN's valuation?

• Expansion into less saturated markets, such as emerging economies with growing healthcare infrastructure.
• Development or licensing of biosimilar versions to capitalize on generic market growth.
• Innovation in delivery methods or combination therapies to add differentiation.
• Advocacy and education to sustain usage in niche indications against DOACs.

What is the outlook for FRAGMIN’s investment case?

The outlook depends heavily on competitive dynamics, patent landscape, and clinical preferences. While current revenues are stable, biosimilar competition poses substantial risk to market share and pricing. Market differentiation remains critical. The potential for strategic diversification into biosimilars or related indications exists but requires significant investment and regulatory navigation.

Long-term viability will depend on the ability to maintain market share against evolving anticoagulant therapies, especially as DOACs continue to gain favor due to ease of administration.

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Key Takeaways

• FRAGMIN holds a significant but declining market share due to patent expirations and biosimilar entry.
• The market size is approximately $10 billion globally, with growth driven by demographic and clinical factors.
• Biosimilar competition and the rise of DOACs create downward pressure on revenues and market share.
• Strategic focus on emerging markets and biosimilar development may mitigate long-term risks.
• Financial valuation should incorporate declining revenue projections, cost efficiencies, and market penetration strategies.

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FAQs

1. How will biosimilar entry impact FRAGMIN’s market share?
Biosimilars have reduced prices and increased competition, leading to a significant decline in market share for original formulations where biosimilars gain approval and market acceptance.

2. Are there new indications that could bolster FRAGMIN’s future?
Current research mainly explores biosimilars and formulation improvements rather than new indications. The potential for expanded use in cancer-associated thrombosis remains under investigation but is not yet commercialized.

3. How does the shift toward DOACs affect the long-term prospects of injectable LMWHs like FRAGMIN?
The convenience, oral administration, and no need for routine monitoring make DOACs increasingly preferred, limiting growth potential of injectable LMWHs unless specific niche indications are identified.

4. What regions represent opportunities for future growth?
Emerging markets in Asia and Latin America show rising incidence of thrombotic diseases and expanding healthcare infrastructure, offering growth opportunities despite price sensitivity.

5. What strategic moves can extend FRAGMIN's relevance?
Developing biosimilars, exploring novel delivery mechanisms, and expanding into niche indications or combination therapies can help sustain revenue streams.

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Sources

[1] MarketsandMarkets. "Low Molecular Weight Heparin Market by Application, Region — Global Forecast to 2027."
[2] IQVIA. "Biosimilar Market Data, 2022."