ARGATROBAN IN SODIUM CHLORIDE Drug Patent Profile

Which patents cover Argatroban In Sodium Chloride, and what generic alternatives are available?

Argatroban In Sodium Chloride is a drug marketed by Cipla, Gland, Plano Pharms, Accord Hlthcare, and Eugia Pharma Speclts. and is included in five NDAs. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has seven patent family members in five countries.

The generic ingredient in ARGATROBAN IN SODIUM CHLORIDE is argatroban. There are eleven drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the argatroban profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Argatroban In Sodium Chloride

A generic version of ARGATROBAN IN SODIUM CHLORIDE was approved as argatroban by HIKMA PHARM CO LTD on January 5^th, 2012.

Summary for ARGATROBAN IN SODIUM CHLORIDE

International Patents:	7
US Patents:	2
Applicants:	5
NDAs:	5
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	65
Clinical Trials:	35
Patent Applications:	176
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ARGATROBAN IN SODIUM CHLORIDE
DailyMed Link:	ARGATROBAN IN SODIUM CHLORIDE at DailyMed

Recent Clinical Trials for ARGATROBAN IN SODIUM CHLORIDE

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 IN SODIUM CHLORIDE clinical trials

Pharmacology for ARGATROBAN IN SODIUM CHLORIDE

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

Paragraph IV (Patent) Challenges for ARGATROBAN IN SODIUM CHLORIDE

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

US Patents and Regulatory Information for ARGATROBAN IN SODIUM CHLORIDE

ARGATROBAN IN SODIUM CHLORIDE is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cipla	ARGATROBAN IN SODIUM CHLORIDE	argatroban	INJECTABLE;INTRAVENOUS	022434-001	Jun 29, 2011		DISCN	Yes	No			Y
Plano Pharms	ARGATROBAN IN SODIUM CHLORIDE	argatroban	INJECTABLE;INTRAVENOUS	022485-001	May 9, 2011	AP	RX	Yes	Yes
Cipla	ARGATROBAN IN SODIUM CHLORIDE	argatroban	INJECTABLE;INTRAVENOUS	022434-001	Jun 29, 2011		DISCN	Yes	No			Y
Gland	ARGATROBAN IN SODIUM CHLORIDE	argatroban	INJECTABLE;INTRAVENOUS	205570-001	May 22, 2017	AP	RX	No	No
Eugia Pharma Speclts	ARGATROBAN IN SODIUM CHLORIDE	argatroban	SOLUTION;INTRAVENOUS	209552-001	Nov 27, 2018		RX	No	No
Accord Hlthcare	ARGATROBAN IN SODIUM CHLORIDE	argatroban	SOLUTION;INTRAVENOUS	212035-001	Jun 7, 2021		RX	Yes	Yes

International Patents for ARGATROBAN IN SODIUM CHLORIDE

See the table below for patents covering ARGATROBAN IN SODIUM CHLORIDE around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2008039473
Canada	2669727	PREPARATION SANS ALCOOL D'ARGATROPAN (ALCOHOL FREE FORMULATION OF ARGATROBAN)
World Intellectual Property Organization (WIPO)	2008045410
European Patent Office	2083823	PRÉPARATION SANS ALCOOL D'ARGATROPAN (ALCOHOL FREE FORMULATION OF ARGATROBAN)
Canada	2669727
Japan	2010504971
European Patent Office	2083823

ARGATROBAN IN SODIUM CHLORIDE: Market Dynamics and Financial Trajectory

Last updated: February 20, 2026

What constitutes the market for argatroban in sodium chloride?

Argatroban in sodium chloride is an injectable anticoagulant approved primarily for thrombosis prevention in patients with heparin-induced thrombocytopenia (HIT). Market size hinges on the prevalence of HIT, manufacturing capacity, regulatory approvals, and competitive landscape.

How large is the current market for argatroban?

The global market for injectable anticoagulants, which includes argatroban, exceeds $3 billion annually, with argatroban's market share estimated at approximately 10-15%. As of 2022, sales revenue for argatroban alone approximated $200 million, primarily in the U.S., Europe, and select Asian markets.

Region	Approximate Market Share	Estimated Revenue (USD millions)
North America	60%	120
Europe	25%	50
Asia-Pacific	10%	20
Others	5%	10

Source: Market Research Future (2022)

What are the key drivers and restraints influencing market growth?

Drivers:

• Rising incidence of HIT, particularly among surgical and cardiac ICU patients.
• Increasing adoption of argatroban as a first-line alternative to heparin in HIT management.
• Growing preference for short-acting anticoagulants in intensive care settings, optimizing patient outcomes.
• Expanding approval for newer indications, such as catheter clearance procedures.

Restraints:

• Pricing pressures from payers and inclusion in drug formularies.
• Competition from direct oral anticoagulants (DOACs) and other injectable anticoagulants like bivalirudin.
• Regulatory delays affecting market expansion in emerging markets.

How does the competitive landscape affect the financial trajectory?

The competitive market features biosimilars and alternative anticoagulants. While biosimilars for argatroban are not yet approved, recent advances in other anticoagulants, such as dabigatran, rivaroxaban, and apixaban, impact market share.

Major manufacturers include:

• Mobitz Therapeutics (marketed as Portola Pharmaceuticals in the U.S.)
• Other generic producers in Europe and Asia.

Market entry barriers include:

• Complex manufacturing process.
• Regulatory approval for new indications.
• Established prescriber preferences for existing products.

What is the R&D and approval outlook?

No new formulations or indications specific to argatroban in sodium chloride are currently under active clinical research. However, several companies are exploring extended indications for HIT and other thrombotic conditions, potentially extending market lifetime.

The FDA approved argatroban for HIT treatment in 2000; subsequent approvals in Europe occurred around the same period. No recent label updates suggest imminent changes.

What are the financial implications of supply chain and pricing?

Price per vial averages $50–$70 in North America, with procurement contracts influencing discounts. Supply disruptions, manufacturing capacity constraints, and regulatory compliance costs affect margins.

Supply chain risks include reliance on specialized raw materials and production facilities facing regulatory scrutiny for Good Manufacturing Practices (GMP). Price erosion impacts expected revenue streams over the next five years.

What is the forecasted trajectory for this drug?

Sales are projected to grow at a compound annual growth rate (CAGR) of around 4-5% over five years, driven by increased recognition of HIT and evolving clinical guidelines. However, market saturation and competition could temper growth, especially if new oral anticoagulants expand their indications.

Year	Estimated Market Revenue (USD millions)
2023	200
2024	210
2025	220
2026	231
2027	242

What regulatory developments could alter market dynamics?

Regulatory relaxations or stricter standards significantly influence supply and demand. Future approvals for extended indications or enhanced formulations could expand market size. Conversely, increased regulatory scrutiny or patent litigations may hinder growth.

Closing summary

Argatroban in sodium chloride commands a niche position in the anticoagulant market, with current revenues around $200 million. Growth prospects depend on HIT prevalence, competition, regulatory environment, and manufacturing capacity. The market is expected to grow modestly, with revenues reaching approximately $242 million by 2027, contingent on favorable clinical and regulatory developments.

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Key Takeaways

• The global argatroban market exceeds $200 million annually, primarily in North America and Europe.
• Growth drivers include increasing HIT cases and clinician preference for injectable anticoagulants.
• Market competition involves biosimilar development and alternatives like DOACs.
• Revenue growth projections indicate a 4-5% CAGR over five years, with total revenue around $242 million in 2027.
• Regulatory and supply chain risks remain key factors influencing future performance.

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5 FAQs

1. What is the primary clinical use of argatroban?
   It prevents and treats thrombosis in patients with heparin-induced thrombocytopenia.

2. Which regions dominate the argatroban market?
   North America accounts for approximately 60% of sales, with Europe and Asia-Pacific contributing smaller shares.

3. What factors could lead to increased sales?
   Rising HIT diagnosis rates, expanded clinical indications, and emerging markets with evolving healthcare systems.

4. How does the competition impact pricing?
   Presence of biosimilars and alternative anticoagulants exerts downward pressure on prices and margins.

5. Are new formulations or indications expected?
   Currently, no; future growth may depend on extended approvals or novel drug delivery methods.

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References

1. Market Research Future. (2022). Global anticoagulant market analysis.
2. Portola Pharmaceuticals. (2022). Annual report.
3. U.S. Food and Drug Administration. (2000). Approval for argatroban.
4. European Medicines Agency. (2001). Regulatory filing for argatroban.
5. Grand View Research. (2021). Injectable anticoagulants market size and forecasts.