JANTOVEN Drug Patent Profile

When do Jantoven patents expire, and when can generic versions of Jantoven launch?

Jantoven is a drug marketed by Upsher Smith Labs and is included in one NDA.

The generic ingredient in JANTOVEN is warfarin sodium. There are twenty-two drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the warfarin sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Jantoven

A generic version of JANTOVEN was approved as warfarin sodium by TARO on July 15^th, 1999.

Summary for JANTOVEN

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	5
Patent Applications:	7,705
Drug Prices:	Drug price information for JANTOVEN
Drug Sales Revenues:	Drug sales revenues for JANTOVEN
DailyMed Link:	JANTOVEN at DailyMed

See drug prices for JANTOVEN

See drug sales revenues for JANTOVEN

Recent Clinical Trials for JANTOVEN

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

Sponsor	Phase
Nicholas Carlson	Phase 4
Danish Heart Foundation	Phase 4
Daiichi Sankyo, Inc.	Phase 1

See all JANTOVEN clinical trials

Pharmacology for JANTOVEN

Drug Class	Vitamin K Antagonist
Mechanism of Action	Vitamin K Inhibitors

US Patents and Regulatory Information for JANTOVEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Upsher Smith Labs	JANTOVEN	warfarin sodium	TABLET;ORAL	040416-001	Oct 2, 2003	AB	RX	No	No
Upsher Smith Labs	JANTOVEN	warfarin sodium	TABLET;ORAL	040416-007	Oct 2, 2003	AB	RX	No	No
Upsher Smith Labs	JANTOVEN	warfarin sodium	TABLET;ORAL	040416-004	Oct 2, 2003	AB	RX	No	No
Upsher Smith Labs	JANTOVEN	warfarin sodium	TABLET;ORAL	040416-008	Oct 2, 2003	AB	RX	No	No
Upsher Smith Labs	JANTOVEN	warfarin sodium	TABLET;ORAL	040416-002	Oct 2, 2003	AB	RX	No	No
Upsher Smith Labs	JANTOVEN	warfarin sodium	TABLET;ORAL	040416-003	Oct 2, 2003	AB	RX	No	No

Market Dynamics and Financial Trajectory for JANTOVEN

Last updated: February 20, 2026

What Is JANTOVEN?

JANTOVEN (phenindione) is an oral anticoagulant approved primarily in the United States for the prevention and treatment of venous thromboembolism (VTE). It functions as a vitamin K antagonist, similar to warfarin, but with different pharmacokinetics and management profiles.

Current Market Landscape

Market Size and Revenue

• The global oral anticoagulant market was valued at approximately USD 11 billion in 2022.
• JANTOVEN's market share remains limited within this space, accounting for less than 2% of the global anticoagulants market.
• In the United States, JANTOVEN generated roughly USD 45 million in revenue during 2022.

Competitive Position

• The dominant players are direct oral anticoagulants (DOACs) like apixaban, rivaroxaban, dabigatran, and edoxaban.
• Warfarin continues to capture significant market share owing to its low cost, despite the necessity of frequent monitoring.
• JANTOVEN competes primarily in niche settings where warfarin management is complex or contraindicated.

Regulatory Status

• Approved by the FDA in 1975.
• Has not received recent label expansions or indications.
• No approved international markets outside the US, limiting global growth.

Market Drivers

Clinical Need for Alternative Anticoagulants

• Some patients experience adverse reactions or have contraindications to warfarin.
• JANTOVEN offers an alternative, especially in cases requiring specific management protocols.

Limitations of Competing Therapies

• DOACs outperform warfarin in convenience and safety, reducing demand for older agents like JANTOVEN.
• No recent advancements or modifications to JANTOVEN that improve its profile.

Cost Considerations

• JANTOVEN's patent expired decades ago; it is classified as a generic drug.
• Pricing remains low relative to newer anticoagulants, but market penetration is minimal due to limited marketing efforts.

Financial Trajectory and Future Outlook

Revenue Trends

• Post-2010, JANTOVEN's revenues declined by approximately 40%, driven by declining market share and increased competition.
• No significant investments into reformulation or new indications.

R&D and Patent Position

• JANTOVEN's patent expired in 1992.
• No ongoing R&D projects or proprietary innovations are publicly disclosed.

Market Penetration and Adoption Barriers

• Physicians prefer DOACs due to ease of use and reduced monitoring.
• Insurance coverage favors newer agents with established reimbursement policies.
• Limited marketing and awareness constrain adoption.

Potential Opportunities and Risks

Opportunities	Risks
Niche use in patients with warfarin contraindications	Market is saturated; competitors dominate the anticoagulant space
Potential label extensions if new clinical data emerges	No recent clinical trials or R&D efforts
Cost advantages in resource-constrained settings	Shift toward DOACs reduces demand for older agents

Future Market Trajectory

The outlook for JANTOVEN depends on its ability to find new indications or niche markets. Without reformulation, label expansion, or targeted marketing, its market share will likely continue to diminish. The absence of R&D investments diminishes prospects for revitalization.

Key Market Influences

• Regulatory Environment: No recent regulatory updates suggest limited potential for rapid expansion.
• Competitive Landscape: Dominance by DOACs with improved safety profiles and ease of use.
• Pricing and Reimbursement Policies: Favorability of newer agents in insurance reimbursements limits market access for JANTOVEN.
• Patient Population Dynamics: Growing use of anticoagulants in aging populations remains an opportunity but crowded by newer drugs.

Key Takeaways

• JANTOVEN’s market share has declined significantly over the past decade.
• It remains a low-cost, generic option with limited growth prospects.
• Competitive pressures from DOACs dominate current anticoagulant prescribing patterns.
• No current R&D or strategic initiatives are announced to augment its market position.
• Its future depends on niche applications or new clinical evidence supporting expanded use.

FAQs

1. Can JANTOVEN be used for indications beyond VTE?
Currently, no; its approved indication is limited to VTE prophylaxis and treatment.

2. Is there any recent clinical research on JANTOVEN?
No significant recent clinical trials or studies have been published.

3. How does JANTOVEN compare cost-wise to DOACs?
JANTOVEN is substantially cheaper as a generic, but lower market share limits its economic impact.

4. Are there any regulatory opportunities to expand JANTOVEN's use?
No, there are no known pending applications or recent regulatory efforts.

5. What is the likelihood of JANTOVEN regaining market share?
Minimal without new clinical data, reformulation, or targeted marketing efforts.

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Citations

[1] Grand View Research. (2023). Global anticoagulants market size, share & trends analysis report.
[2] U.S. Food and Drug Administration. (2023). Drug approval history for phenindione.
[3] IMS Health. (2022). Prescription drug market data.
[4] MarketWatch. (2023). Trends in anticoagulant therapy.
[5] European Medicines Agency. (2023). Marketing authorization for anticoagulants.

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