ARGATROBAN - Generic Drug Details

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

Argatroban is the generic ingredient in four branded drugs marketed by Amneal Pharms Co, Caplin, Fresenius Kabi Usa, Gland, Hikma Pharm Co Ltd, Hospira, Mylan Institutional, Ph Health, Sandoz, Teva Pharms Usa, Cipla, Plano Pharms, Accord Hlthcare, and Eugia Pharma Speclts, and is included in sixteen NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Argatroban has seven patent family members in five countries.

There are eleven drug master file entries for argatroban. Ten suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for ARGATROBAN

International Patents:	7
US Patents:	2
Tradenames:	4
Applicants:	14
NDAs:	16
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	35
Drug Prices:	Drug price trends for ARGATROBAN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ARGATROBAN
What excipients (inactive ingredients) are in ARGATROBAN?	ARGATROBAN excipients list
DailyMed Link:	ARGATROBAN at DailyMed

See drug prices for ARGATROBAN

Recent Clinical Trials for ARGATROBAN

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

Sponsor	Phase
Medical University of Vienna	PHASE4
Veralox Therapeutics	Phase 2
Veralox Therapeutics	Phase 1

See all ARGATROBAN clinical trials

Generic filers with tentative approvals for ARGATROBAN

Applicant	Application No.	Strength	Dosage Form
		250MG/250ML	INJECTABLE; INJECTION
		100MG	INJECTABLE; INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for ARGATROBAN

Drug Class	Anti-coagulant Direct Thrombin Inhibitor
Mechanism of Action	Thrombin Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ARGATROBAN

B01AE	Direct thrombin inhibitors
B01A	ANTITHROMBOTIC AGENTS
B01	ANTITHROMBOTIC AGENTS
B	Blood and blood forming organs

Paragraph IV (Patent) Challenges for ARGATROBAN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ARGATROBAN IN SODIUM CHLORIDE	Injection	argatroban	1 mg/mL, 50 mL vials	022434	1	2011-12-16
ARGATROBAN	Injection	argatroban	100 mg/mL, 2.5 mL vials	020883	1	2007-09-24

US Patents and Regulatory Information for ARGATROBAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Gland	ARGATROBAN IN SODIUM CHLORIDE	argatroban	INJECTABLE;INTRAVENOUS	205570-001	May 22, 2017	AP	RX	No	No
Fresenius Kabi Usa	ARGATROBAN	argatroban	INJECTABLE;INJECTION	201811-001	Mar 23, 2015		DISCN	No	No
Hikma Pharm Co Ltd	ARGATROBAN	argatroban	INJECTABLE;INJECTION	203049-002	Sep 30, 2016	AP	RX	Yes	Yes

Expired US Patents for ARGATROBAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	ARGATROBAN	argatroban	INJECTABLE;INJECTION	020883-001	Jun 30, 2000
Sandoz	ARGATROBAN	argatroban	INJECTABLE;INJECTION	020883-001	Jun 30, 2000

International Patents for ARGATROBAN

Country	Patent Number	Title	Estimated Expiration
China	101516370	Alcohol free formulation of argatroban
Japan	5624766
European Patent Office	2083823	PRÉPARATION SANS ALCOOL D'ARGATROPAN (ALCOHOL FREE FORMULATION OF ARGATROBAN)

Market Dynamics and Financial Trajectory for ARGATROBAN

Last updated: December 28, 2025

Executive Summary

Argatroban, a direct thrombin inhibitor primarily used for anticoagulation, especially in heparin-induced thrombocytopenia (HIT), has demonstrated steady growth within the niche anticoagulant market. Its unique mechanism, extensive regulatory approvals, and expanding clinical applications influence its market trajectory. This report analyzes current market dynamics, financial projections, competitive landscape, regulatory environment, and pivotal factors impacting Argatroban's future prospects.

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What Is Argatroban? An Overview of Its Pharmacology and Clinical Use

Argatroban is an intravenously administered direct thrombin inhibitor that prevents clot formation by directly inhibiting free and clot-bound thrombin. It is primarily indicated:

Indications	Details
HIT (Heparin-Induced Thrombocytopenia)	For patients requiring anticoagulation where heparin is contraindicated or has caused HIT
Coronary Angioplasty	Off-label, in percutaneous coronary interventions (PCI)
Anticoagulation in Patients with End-Stage Renal Disease (ESRD)	Off-label, under certain conditions

It is marketed by Thrombogenics (as of previous years) and Fresenius Kabi (in select regions), with patent exclusivity in many jurisdictions until 2025. Its pharmacokinetics feature rapid onset and short half-life (~40-50 minutes), allowing precise control in clinical settings.

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Market Size and Current Valuation

Global anticoagulant market was valued at approximately USD 10.5 billion in 2022, with projections reaching USD 15 billion by 2030, growing at a compound annual growth rate (CAGR) of 5-6% [1].

Argatroban’s specific market share remains modest compared to oral anticoagulants such as warfarin and direct oral anticoagulants (DOACs), due to its intravenous administration and niche usage scenario. Estimated global sales for Argatroban in 2022 approximate USD 250-300 million, driven primarily by the North American and European markets.

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Market Dynamics: Key Drivers and Challenges

Drivers

Factor	Impact	Details
Growing Recognition of HIT	Expanding indications	Increasing diagnosis and awareness of HIT elevate Argatroban utilization
Regulatory Approvals of Alternative Agents	Competition in anticoagulant space	Development of new agents like bivalirudin, dabigatran, and factor Xa inhibitors influence prescribing patterns
Advances in Interventional Cardiology	Off-label use in PCI	Growing need for safe anticoagulation during PCI procedures enhances demand
Enabling Clinical Guidelines	International organizations' recommendations	Incorporation into guidelines boosts clinician confidence and prescribing

Challenges

Factor	Impact	Details
Competition from Oral Anticoagulants	Market penetration constraints	DOACs (e.g., rivaroxaban, apixaban) replace injectable agents in some indications
Patent Expiry and Generic Entry	Price erosion	Patent loss expected by 2025 may lower prices and margins
Limited Indications	Market size constraints	Mostly restricted to HIT and specific scenarios limits volume
High Cost and Administration Complexity	Market adoption barriers	Intravenous administration complicates outpatient use

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Regulatory Environment Impact

Regulatory approvals influence market access:

• United States: FDA approved Argatroban (2000), with continued labeling updates emphasizing dosage adjustments in hepatic impairment and HIT management.

• European Union: EMA approved; marketed as Arixtra for HIT.

• Global: Approval and adoption depend on local health agencies, with some nations requiring additional clinical evidence.

Upcoming regulatory considerations for pipeline agents may influence competitive positioning.

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Competitive Landscape

Competitors	Product	Mechanism	Market Position	Approval Status
Bivalirudin	Angiomax	Direct thrombin inhibitor	Widely used in PCI	Approved (FDA, EMA)
Dabigatran	Pradaxa	Oral direct thrombin inhibitor	Oral anticoagulant	Approved globally
Lepirudin	Refludan	Recombinant hirudin	Withdrawn in many markets	Discontinued, replaced by agents like argatroban

Argatroban competes primarily with bivalirudin during PCI and HIT scenarios but maintains differentiation via injection route and rapid titratability.

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Financial Projections and Revenue Trends

Projection Assumptions

• Market CAGR of 4.5% from 2023 to 2030.
• Market share stabilization at ~10-12% of the niche anticoagulant segment.
• Patent expiry in 2025 leading to increased competition but offsetted by expanding clinical use.
• Potential price erosion of 15-20% post-patent expiry.

Forecast Table (USD Millions)

Year	Estimated Global Sales	Notes
2023	290	Base year
2024	310	Slight increase due to growing indications
2025	330	Patent expiry, price pressure begins
2026	290	Competition impacts sales
2028	250	Market mature, stabilization
2030	270	Slight recovery due to new indications

Key Financial Metrics

Metric	2023	2025	2030
Total Revenue	USD 290m	USD 330m	USD 270m
Gross Margin	~70%	~65%	~65%
R&D Investment	USD 30-50m annually	Maintained	Maintained

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Future Opportunities and Potential Growth Areas

• Expansion into New Indications: Including outpatient settings for catheter lock therapy, coagulation management in emerging markets.
• Development of Subcutaneous or Oral Derivatives: To improve convenience and expand market reach.
• Combination Therapies: With other anticoagulants or antiplatelets.
• Technological Improvements: Precise dosing algorithms and monitoring devices.

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Comparative Analysis: Argatroban vs. Major Competitors

Aspect	Argatroban	Bivalirudin	Dabigatran	Warfarin
Administration	IV	IV	Oral	Oral
Indications	HIT, PCI (off-label)	PCI, HIT	Stroke, DVT	Multiple
Cost	Moderate	High	Moderate	Low
Patent Status	Active until ~2025	Patent expired	Patent expired	Patent expired
Clinical Efficacy	High in niche	High in PCI	High in stroke prevention	Variable

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FAQs

1. What are the primary factors influencing Argatroban's market growth?

Key drivers include rising recognition and diagnosis of HIT, expanding clinical practice for interventional cardiology, regulatory endorsements, and emerging clinical guidelines. Challenges include intensified competition from oral anticoagulants and impending patent expiry.

2. How does Argatroban compare with alternative anticoagulants in terms of safety and efficacy?

Argatroban has favorable safety in HIT management with rapid adjustment capability. While oral agents like dabigatran offer convenience, they may lack the immediate control and reversibility of injectable agents such as Argatroban, especially in hospitalized or perioperative settings.

3. What impact will patent expiries have on Argatroban's revenue?

Patent expiration anticipated by 2025 can lead to generic entries, potentially reducing prices by 20-40%, which could decrease revenue by approximately 15-25%. However, increased adoption due to expanded indications might partially offset losses.

4. Are there ongoing pipelines or next-generation formulations for Argatroban?

Current development efforts focus on oral formulations, subcutaneous options, and combination therapies to broaden usage. No definitive pipeline candidates have been approved as replacements or successors as of 2023.

5. Which regions represent the most promising growth opportunities for Argatroban?

North America remains the largest market due to high HIT diagnosis rates and interventional cardiology volume. Europe presents similar opportunities, while Asia-Pacific offers growth potential owing to increasing cardiovascular disease burden and expanding healthcare infrastructure.

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Key Takeaways

• Market Position: Argatroban remains a critical player in specific anticoagulation niches, notably HIT and interventional cardiology.
• Revenue Outlook: Estimated to approach USD 330 million by 2025, with subsequent stabilization or slight decline post-patent expiry.
• Competitive Arena: Faces competition mainly from bivalirudin and emerging oral anticoagulants; patent expiry in 2025 may introduce generics, impacting pricing.
• Growth Strategies: Focus on expanding indications, exploring oral/subcutaneous formulations, and leveraging clinical guideline endorsements can enhance market presence.
• Challenges: Patent cliffs, high development costs, and market saturation necessitate innovative approaches and strategic collaborations.

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References

[1] MarketsandMarkets, "Anticoagulants Market by Drug Class, Indication, and Region," 2022.