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 Pharma Ltd, Sandoz, 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:	148
Clinical Trials:	34
Patent Applications:	110
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
Veralox Therapeutics	Phase 2
Veralox Therapeutics	Phase 1
Celerion	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	7,687,516		Y
Sandoz	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	7,589,106		Y

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
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

ARGATROBAN IN SODIUM CHLORIDE Market Analysis and Financial Projection Experimental

Argatroban in Sodium Chloride: Market Dynamics and Financial Trajectory

Market Overview

Argatroban, a synthetic direct thrombin inhibitor, has been a crucial anticoagulant in the medical field, particularly for patients with heparin-induced thrombocytopenia (HIT). When formulated in sodium chloride, it enhances its stability and efficacy. Here’s a detailed look at the market dynamics and financial trajectory of Argatroban in Sodium Chloride.

Market Size and Growth

The argatroban market, including its formulation in sodium chloride, is projected to grow significantly over the forecast period of 2022-2027. The market is estimated to reach $1.65 billion by 2027, growing at a CAGR of 3.9%[3][5].

Key Drivers

Rising Prevalence of Cardiovascular Diseases

The increasing incidence of cardiovascular diseases, such as peripheral artery disease and thrombosis, is a major driver for the argatroban market. For instance, the prevalence of peripheral artery disease (PAD) in the United States is projected to be around 7%, affecting approximately 8.5 million people[1].

Growing Demand for Safe and Effective Anticoagulants

The need for safe and effective anticoagulants, especially in cases where heparin is contraindicated, drives the demand for argatroban. The drug's efficacy in treating HIT and its use in percutaneous coronary intervention (PCI) procedures further boost its market growth[3][5].

Government Initiatives and Healthcare Infrastructure

Government initiatives aimed at improving healthcare infrastructure, particularly in emerging regions, and favorable reimbursement policies in North America and Europe, contribute to the market's expansion[5].

Market Segmentation

By Application

The argatroban market is segmented into several applications, with HIT being the largest segment. This is due to the growing adoption of argatroban as a safe and effective treatment for HIT. Other significant segments include PCI and cerebral arterial thrombosis[3][5].

By Geography

North America and Europe currently dominate the argatroban market, with a combined significant share. However, the Asia-Pacific region is expected to witness the fastest growth due to the rising incidence of cardiovascular diseases and increasing healthcare expenditure[3][5].

By Product

The argatroban injection segment, particularly the ready-to-use (RTU) formulation in sodium chloride, is expected to grow with the fastest CAGR during the forecast period. This growth is attributed to the heightened application of argatroban as an anticoagulant in various medical procedures[3].

Challenges and Restraints

High Initial Cost

The high initial cost of argatroban, compared to other anticoagulants, limits its accessibility in cost-sensitive markets. This is a significant restraint to the market's growth[4].

Competition and Regulatory Hurdles

Competition from other anticoagulants and emerging therapies, along with stringent regulatory approvals and compliance requirements, pose challenges to the market. These factors can slow down new approvals and innovations[4].

Supply Chain Disruptions

Limited availability of raw materials and supply chain disruptions, exacerbated by events like the COVID-19 pandemic, can affect argatroban production processes and market stability[1][4].

Opportunities and Innovations

Expanding Indications and Regulatory Approvals

Potential opportunities lie in expanding indications for argatroban, regulatory approvals in new regions, and further research into optimizing dosing protocols for specific patient subgroups. Innovations in cost-effective supply chains and generic formulations could also drive growth[4].

Personalized Medicine and Digital Health Technologies

Research focused on personalized medicine approaches and therapeutic drug monitoring enhanced by digital health technologies may drive future market expansion. The introduction of novel drug delivery technologies, such as nanotechnology-based formulations, is also anticipated to boost the market[4][5].

Recent Developments

In June 2021, Accord Healthcare received FDA approval for Argatroban in Sodium Chloride, marking a significant development in the market. Similarly, Caplin Steriles Limited received final approval from the FDA for its abbreviated new drug application (ANDA) for argatroban injection in January 2021[5].

Leading Players

Key players in the argatroban market include Daiichi Sankyo Company Limited, Novartis AG, Viatris Inc, Par Pharmaceutical, Hikma Pharmaceuticals PLC, Caplin Steriles Ltd, AuroMedics Pharma LLC, Fresenius Kabi USA, Mitsubishi Tanabe Pharma, and Pfizer Inc. These companies are focusing on collaborative research, targeted marketing strategies, and partnerships with healthcare organizations to integrate argatroban into broader treatment protocols[5].

Financial Trajectory

The financial trajectory of the argatroban market is positive, driven by increasing demand and expanding applications. Despite challenges such as high costs and regulatory hurdles, the market is expected to grow steadily. The focus on cost-effective strategies, generic formulations, and innovative delivery technologies will be crucial in maintaining this growth.

"Recognizing the delicate balance between cost, efficacy, and safety will be vital in navigating and thriving in this competitive market landscape."[4]

Key Takeaways

• The argatroban market is projected to grow at a CAGR of 3.9% from 2022 to 2027.
• The market is driven by the rising prevalence of cardiovascular diseases and the growing demand for safe and effective anticoagulants.
• North America and Europe dominate the market, but the Asia-Pacific region is expected to witness the fastest growth.
• High initial costs and competition from other anticoagulants are significant restraints.
• Innovations in drug delivery technologies and personalized medicine approaches offer future growth opportunities.

FAQs

What is the primary use of Argatroban in Sodium Chloride?

Argatroban in Sodium Chloride is primarily used as an anticoagulant for the treatment of heparin-induced thrombocytopenia (HIT) and for prophylaxis or treatment of thrombosis in patients with HIT.

What are the key drivers of the Argatroban market?

The key drivers include the rising prevalence of cardiovascular diseases, growing demand for safe and effective anticoagulants, and government initiatives to improve healthcare infrastructure.

Which region is expected to witness the fastest growth in the Argatroban market?

The Asia-Pacific region is expected to witness the fastest growth during the forecast period due to the rising incidence of cardiovascular diseases and increasing healthcare expenditure.

What are the main challenges facing the Argatroban market?

The main challenges include high initial costs, competition from other anticoagulants, and stringent regulatory approvals and compliance requirements.

Who are the leading players in the Argatroban market?

Leading players include Daiichi Sankyo Company Limited, Novartis AG, Viatris Inc, Par Pharmaceutical, and Hikma Pharmaceuticals PLC, among others.

Cited Sources:

1. Mordor Intelligence: Argatroban Market Size & Share Analysis - Industry Research Report
2. FDA: 022434Orig1s000 - accessdata.fda.gov
3. Industry ARC: Argatroban Market Share, Size and Industry Growth Analysis 2020
4. Research and Markets: Argatroban Market Size, Competitors & Forecast to 2030
5. Data Insights Market: Global Argatroban Market Report Probes the XX Million Size, Share ...