ARGATROBAN - Generic Drug Details

What are the generic sources for argatroban and what is the scope of patent protection?

Argatroban is the generic ingredient in four branded drugs marketed by Amneal Pharms Co, Caplin, Endo Operations, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Pharm Co Ltd, Hospira, Mylan Institutional, Sandoz, Teva Pharms Usa, Cipla, 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. Eleven 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:	13
NDAs:	16
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	86
Clinical Trials:	34
Patent Applications:	245
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
Veralox Therapeutics	Phase 2
Celerion	Phase 1
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
Sandoz	ARGATROBAN IN SODIUM CHLORIDE	argatroban	INJECTABLE;INTRAVENOUS	022485-001	May 9, 2011	AP	RX	Yes	Yes
Gland Pharma Ltd	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	AP	RX	No	No
Cipla	ARGATROBAN IN SODIUM CHLORIDE	argatroban	INJECTABLE;INTRAVENOUS	022434-001	Jun 29, 2011		DISCN	Yes	No	7,589,106		Y
Eugia Pharma Speclts	ARGATROBAN IN SODIUM CHLORIDE	argatroban	SOLUTION;INTRAVENOUS	209552-001	Nov 27, 2018		RX	No	No
Gland Pharma Ltd	ARGATROBAN	argatroban	INJECTABLE;INJECTION	217848-001	Jul 31, 2023	AP	RX	No	No
Amneal Pharms Co	ARGATROBAN	argatroban	INJECTABLE;INJECTION	206698-001	Jan 26, 2018	AP	RX	No	No

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	5,214,052
Sandoz	ARGATROBAN	argatroban	INJECTABLE;INJECTION	020883-001	Jun 30, 2000	5,925,760

International Patents for ARGATROBAN

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2083823	PRÉPARATION SANS ALCOOL D'ARGATROPAN (ALCOHOL FREE FORMULATION OF ARGATROBAN)
Canada	2669727	PREPARATION SANS ALCOOL D'ARGATROPAN (ALCOHOL FREE FORMULATION OF ARGATROBAN)
Japan	5624766
China	101516370	Alcohol free formulation of argatroban
Japan	2010504971
World Intellectual Property Organization (WIPO)	2008039473
World Intellectual Property Organization (WIPO)	2008045410

ARGATROBAN Market Analysis and Financial Projection Experimental

Argatroban Market Dynamics and Financial Trajectory

Market Overview

The argatroban market is a specialized segment within the pharmaceutical industry, primarily focused on anticoagulant therapies. Argatroban, a synthetic direct thrombin inhibitor, is used to prevent and treat thrombosis, particularly in patients with heparin-induced thrombocytopenia (HIT)[5].

Market Size and Growth

The global argatroban market has shown mixed projections depending on the source. According to some reports, the market is expected to register a CAGR of 3.5% over the forecast period from 2022 to 2027, driven by the increasing prevalence of cardiovascular disorders and the need for alternative anticoagulants[1][3].

However, other reports suggest a more pessimistic outlook, with the market forecast to decline at a CAGR of -5.4% from 2023 to 2030, reducing from USD 65 million in 2023 to USD 44 million by 2030. This decline is attributed to various market challenges and the impact of the COVID-19 pandemic[2].

Regional Performance

• North America: This region is anticipated to dominate the global argatroban market due to the high incidence of cardiovascular disorders, such as stroke, coronary artery disease, and peripheral artery disease. Regulatory approvals and the development of new formulation products also contribute to its dominance[1][3].
• Asia-Pacific: This region is expected to be the fastest-growing market for argatroban, driven by increasing healthcare investments and a growing awareness of thromboembolic disorders[1].

Market Drivers

Several factors are driving the growth of the argatroban market:

• Increasing Prevalence of Thromboembolic Disorders: The rising incidence of conditions such as HIT, acute cerebral thrombosis, and chronic arterial occlusion is driving the demand for argatroban[1][4].
• Advancements in Anticoagulant Formulations: Improvements in anticoagulant formulations and delivery systems are enhancing the efficacy and patient compliance of argatroban[4].
• Growing Healthcare Infrastructure: Investments in healthcare infrastructure and research are propelling the market expansion of argatroban[4].
• Strategic Partnerships: Collaborations among key players are driving market dynamics and innovation in the argatroban market[4].

Market Restraints

Despite the drivers, the argatroban market faces several challenges:

• High Initial Cost: The high cost of argatroban limits its accessibility in cost-sensitive markets, making it less competitive compared to other anticoagulants[2][4].
• Competition from Other Anticoagulants: The presence of other anticoagulants and emerging therapies poses a significant competitive threat to argatroban[2][4].
• Stringent Regulatory Approvals: The rigorous regulatory requirements can slow down new approvals and market entry of argatroban products[4].

Market Opportunities

There are several opportunities for growth in the argatroban market:

• Expanding Indications: Potential expansions in the indications for argatroban, such as new regions and patient subgroups, could drive market growth[4].
• Research and Development: Increasing investments in research and development for novel anticoagulant drugs and optimizing dosing protocols can yield substantial growth[4].
• Emerging Economies: The expansion of the argatroban market in emerging economies with a focus on healthcare improvement presents significant opportunities[4].

Impact of COVID-19

The COVID-19 pandemic had a significant impact on the argatroban market. It caused disruptions in supply chains and treatment protocols, delayed research and development, and increased the incidence of thrombosis among hospitalized patients. However, as vaccination campaigns progress and COVID-19 cases decline, the market is expected to recover and reach its full potential[1][3].

Key Players

The argatroban market is characterized by a few key players, including:

• Mitsubishi Tanabe Pharma Corporation
• AuroMedics Pharma LLC
• Pfizer Inc.
• Viatris Inc.
• Hikma Pharmaceuticals PLC
• SANDOZ
• GlaxoSmithKline Plc
• Fresenius Kabi
• Eagle Pharmaceuticals[1][2][3].

Financial Trajectory

The financial trajectory of the argatroban market is complex and influenced by various factors. Here are some key financial insights:

• Market Size: The market size was valued at USD 65 million in 2023 but is forecast to decline to USD 44 million by 2030, according to some reports[2].
• Revenue Projections: Despite the decline in overall market size, the revenue generated from argatroban sales is expected to be influenced by the increasing demand in certain regions and the expansion of indications[1][4].
• Cost Structure: The high initial cost of argatroban is a significant factor affecting its market penetration. However, cost-effective supply chains and generic formulations could improve its financial viability[4].

Conclusion

The argatroban market is dynamic and highly specialized, with both growth opportunities and challenges. The market's financial trajectory is influenced by factors such as the increasing prevalence of thromboembolic disorders, advancements in anticoagulant formulations, and the impact of the COVID-19 pandemic. Addressing the high initial cost, competition from other anticoagulants, and stringent regulatory requirements will be crucial for the market's sustained growth.

Key Takeaways

• The argatroban market is expected to grow at a CAGR of 3.5% from 2022 to 2027, but may decline at a CAGR of -5.4% from 2023 to 2030.
• North America dominates the market, while Asia-Pacific is the fastest-growing region.
• The market is driven by the increasing prevalence of thromboembolic disorders and advancements in anticoagulant formulations.
• High initial cost, competition, and stringent regulatory approvals are significant restraints.
• Opportunities lie in expanding indications, research and development, and market expansion in emerging economies.

FAQs

Q: What is the current global argatroban market size? A: The global argatroban market was valued at USD 65 million in 2023[2].

Q: Who are the key players in the global argatroban market? A: Key players include Mitsubishi Tanabe Pharma Corporation, AuroMedics Pharma LLC, Pfizer Inc, Viatris Inc, and Hikma Pharmaceuticals PLC[1][2].

Q: Which region is the fastest-growing market for argatroban? A: The Asia-Pacific region is estimated to grow at the highest CAGR over the forecast period[1].

Q: What are the primary drivers of the argatroban market? A: Drivers include the increasing prevalence of thromboembolic disorders, advancements in anticoagulant formulations, and growing healthcare infrastructure investments[4].

Q: What are the major challenges facing the argatroban market? A: Challenges include the high initial cost, competition from other anticoagulants, and stringent regulatory approvals[2][4].

Cited Sources

1. Mordor Intelligence: Argatroban Market Size & Share Analysis - Industry Research Report
2. NewsChannelNebraska: Argatroban Market Research 2024: Industry Revenue, Future Demand, and Regional Growth Prospects to 2032
3. Mordor Intelligence: Global Argatroban Market Size | Mordor Intelligence
4. ResearchAndMarkets: Argatroban Market Size, Competitors & Forecast to 2030
5. Science.gov: Argatroban injection solution: Topics by Science.gov