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. Ten 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
Japan	5624766
China	101516370	Alcohol free formulation of argatroban
Japan	2010504971

Market Dynamics and Financial Trajectory for ARGATROBAN IN SODIUM CHLORIDE

Last updated: July 29, 2025

---

Introduction

Argatroban in sodium chloride—a synthetic direct thrombin inhibitor—is a critical pharmaceutical agent used primarily for anticoagulation in patients with heparin-induced thrombocytopenia (HIT). Its unique mechanism of action, coupled with increasing clinical applications, positions it as a significant player within the global anticoagulant market. Understanding the evolving market dynamics and financial trajectory of argatroban in sodium chloride requires a comprehensive analysis of current demand-supply fundamentals, regulatory landscape, competitive positioning, and upcoming technological developments.

---

Market Overview and Current Industry Landscape

The global anticoagulants market was valued at approximately USD 25 billion in 2022, with projected growth at a compound annual growth rate (CAGR) of around 6% through 2030, driven by rising incidences of thrombotic disorders, cardiovascular diseases, and expanding aging populations. Argatroban, as a direct thrombin inhibitor indicated for HIT and reagent use, occupies a niche segment within this broader market.

Major pharmaceutical companies such as Lundbeck (acquired by000**Baxter’s line of argatroban products), Teva Pharmaceuticals, and other regional producers dominate the supply chain, compounded by need for regulatory approvals across different jurisdictions. The drug's status as an injectable anticoagulant formulates a barrier to over-the-counter adoption but ensures its essential role in hospital protocols.

---

Market Drivers

• Increasing Incidence of HIT and Thrombotic Conditions: The prevalence of HIT, which complicates heparin therapy, creates sustained demand for argatroban. The SHIELD trial and similar studies underscore its efficacy, fostering physician confidence.

• Expanding Use Cases: Beyond HIT, argatroban's application extends to acute coronary syndromes and as a diagnostic reagent, supporting market expansion.

• Regulatory Milestones: Approval from agencies like the FDA and EMA, including as an anticoagulant in cardiac surgery, continuously broadens its therapeutic spectrum.

• Advancements in Biotech Manufacturing: Enhanced synthesis techniques and process optimization lower production costs, augmenting profit margins.

---

Market Challenges and Constraints

• Price Competition and Generics: Patent expirations in key markets threaten pricing power. Although argatroban's patents are largely in force, generic formulations could undercut premium pricing.

• Regulatory Hurdles in Emerging Markets: Navigating regulatory environments in Asia, Latin America, and Africa presents delays and additional costs.

• Alternative Therapies: The emergence of oral anticoagulants (DOACs) such as rivaroxaban and apixaban, which offer convenience over injectables, threaten the growth of injectable agents.

• Supply Chain and Manufacturing Risks: Disruptions, especially given the specialized nature of supply chains, can delay production scales, affecting margins.

---

Financial Trajectory and Investment Outlook

Revenue Projections

The financial outlook for argatroban in sodium chloride hinges on several key variables:

• Market Penetration: With the global thrombotic disorder market projected to grow, argatroban’s share is expected to increase modestly, sustained by ongoing clinical demand.

• Pricing Strategies: Premium pricing in developed markets may stabilize revenues, though competition and potential generics pressure could compress margins over time.

• Cost Dynamics: Manufacturing costs are decreasing due to process innovations, improving profitability. Additionally, the shift toward biosimilars and advanced synthesis techniques could influence gross margins.

Investment Trends

• Venture capital and R&D investments are historically modest for argatroban, given its established market position. However, strategic partnerships for pipeline expansion or formulation innovations—such as subcutaneous delivery—could invigorate financial prospects.

• M&A Activity: Larger firms seek acquisitions of niche anticoagulants to diversify portfolios, which could drive merger-driven revenue synergies.

Emerging Opportunities

• Pharmacogenomics Integration: Personalizing anticoagulation therapy with precision medicine could extend argatroban’s indications and market reach.

• New Formulations: Developing oral derivatives or long-acting formulations may open new revenue streams, especially in outpatient settings.

---

Regulatory and Competitive Factors

Regulatory bodies maintain rigorous standards for manufacturing, safety, and efficacy, influencing the speed at which new formulations or indications emerge. Patent landscapes and exclusivity periods shape profitability timelines; for argatroban, patent protections are pending or existing in key markets.

Competitive pressure from oral anticoagulants—particularly DOACs—is a significant factor. While oral agents enjoy convenience, injectable agents like argatroban maintain clinical relevance in acute care and procedural settings, ensuring a continued, albeit moderated, demand.

---

Technological Innovations and Future Directions

Advancements in nanotechnology, personalized medicine, and biosensor integration could revolutionize anticoagulation management. For argatroban, innovations such as targeted delivery systems or combination therapies could enhance efficacy, safety, and marketability, extending its financial trajectory.

---

Market Opportunities and Risks

Opportunities:

• Expanding indications in cardiac and neurovascular surgeries
• Developing combination therapies with antiplatelets
• Entering emerging markets with favorable regulatory policies

Risks:

• Competition from newer anticoagulants
• Regulatory restrictions or safety concerns
• Patent expirations leading to generic entries

---

Conclusion

The financial trajectory of argatroban in sodium chloride is influenced by a complex interplay of clinical demand, technological innovation, competitive dynamics, and regulatory considerations. While it remains essential in specific therapeutic niches, the evolution of anticoagulant therapies necessitates continuous adaptation and innovation to sustain profitability. Stakeholders should monitor pipeline developments, regional market trends, and the competitive landscape to harness this agent’s potential effectively.

---

Key Takeaways

• Market demand remains robust due to the high prevalence of thrombotic disorders and specific clinical settings requiring injectable anticoagulants.
• Competitive pressures from oral anticoagulants pose challenges but also highlight opportunities for innovation within injectables.
• Pricing and patent strategies critically influence the financial health of argatroban products; diversification and pipeline expansion are key for future growth.
• Regulatory navigation and regional market entry are essential to capitalize on emerging market opportunities.
• Technological advancements (e.g., personalized medicine, novel formulations) could extend the drug’s relevance and expand its revenue streams.

---

FAQs

1. How does argatroban’s market position compare to other anticoagulants?
Argatroban primarily targets HIT management and certain procedural applications, occupying a niche segmented by its injectable formulation. Oral anticoagulants such as rivaroxaban and apixaban dominate broader markets due to ease of use, but argatroban’s specialized role sustains its relevance in acute care.

2. What are the key regulatory considerations impacting argatroban’s financial trajectory?
Regulatory approvals determine geographic market access, influence pricing, and protect patent rights. Stringent safety and efficacy standards may delay approval of new formulations or indications, affecting revenue growth.

3. Will patent expiries affect argatroban’s profitability?
While current patents provide exclusivity, expiration or challenge could lead to generic competition, putting downward pressure on prices and margins in affected markets.

4. Are there emerging innovations that could disrupt argatroban’s market?
Yes, development of oral direct thrombin inhibitors and novel anticoagulants could reduce dependence on injectable agents in some settings, challenging argatroban’s market share.

5. How can pharmaceutical companies extend argatroban’s market life?
Investing in new formulations, expanding indications through clinical trials, and leveraging personalized medicine approaches can sustain growth and optimize financial returns.

---

Sources:

1. MarketsandMarkets. "Anticoagulants Market by Product, Application, and Region." 2022.
2. U.S. Food and Drug Administration (FDA). "Argatroban Prescribing Information." 2022.
3. GlobalData. "Anticoagulant Drugs Market Forecast," 2022.
4. European Medicines Agency (EMA). "Regulatory Updates on Anticoagulants," 2022.
5. ClinicalTrials.gov. "Studies Evaluating Argatroban Use and New Indications," 2023.