PHENINDIONE - Generic Drug Details

What are the generic sources for phenindione and what is the scope of freedom to operate?

Phenindione is the generic ingredient in one branded drug marketed by Sanofi Aventis Us and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for PHENINDIONE

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	90
Clinical Trials:	4
DailyMed Link:	PHENINDIONE at DailyMed

Recent Clinical Trials for PHENINDIONE

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

Sponsor	Phase
University of Edinburgh	Phase 3
NHS Lothian	Phase 3
Daiichi Sankyo, Inc.	Phase 3

See all PHENINDIONE clinical trials

Medical Subject Heading (MeSH) Categories for PHENINDIONE

Anticoagulants

Anatomical Therapeutic Chemical (ATC) Classes for PHENINDIONE

B01AA	Vitamin K antagonists
B01A	ANTITHROMBOTIC AGENTS
B01	ANTITHROMBOTIC AGENTS
B	Blood and blood forming organs

US Patents and Regulatory Information for PHENINDIONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sanofi Aventis Us	HEDULIN	phenindione	TABLET;ORAL	008767-002	Approved Prior to Jan 1, 1982		DISCN	No	No

PHENINDIONE Market Analysis and Financial Projection

Last updated: February 13, 2026

What Are the Market Dynamics for Phenindione?

Phenindione is an anticoagulant derived from a class of compounds known as vitamin K antagonists. It gained clinical use primarily in regions where warfarin and other newer anticoagulants are less accessible or where specific regulatory constraints exist. Its market presence is limited compared to standard treatments like warfarin and DOACs (direct oral anticoagulants) such as apixaban or rivaroxaban.

Key factors influencing phenindione’s market include:

1. Regulatory Landscape

   • Approved mainly in select countries; notably used in India and some parts of Europe.
   • Absence from many markets due to safety concerns and limited data compared to newer anticoagulants.
   • Regulatory discontinuations in some regions due to adverse event reports.

2. Therapeutic Competition

   • Dominance of warfarin, with a global market size estimated at USD 5 billion in 2021 [1].
   • Growing adoption of DOACs, which offer fewer food and drug interactions, and do not require routine INR monitoring.
   • Phenindione’s use has declined, with a niche presence in specific cases resistant to other therapies.

3. Clinical and Safety Profile

   • Associated with higher bleeding risks and hepatotoxicity relative to warfarin.
   • Limited clinical trials and post-marketing surveillance hamper confidence.

4. Market Drivers

   • Aged populations with atrial fibrillation needing anticoagulation therapy.
   • Regions with limited access to newer anticoagulants.
   • Healthcare settings where cost is a determining factor, as phenindione is generally cheaper than newer agents.

5. Market Challenges

   • Safety concerns leading to regulatory restrictions.
   • Preference for drugs with established safety and minimal monitoring requirements.
   • Limited commercialization efforts and patent protections expiring for competitive drugs.

What Is the Financial Trajectory of Phenindione?

Phenindione's financial trajectory is characterized by a declining trend with minimal growth prospects, driven primarily by safety issues and competitive pressures.

Revenue and Market Size

• The global market for phenindione is estimated to be below USD 2 million annually, mainly sourced from sales in India and some European countries [2].
• In India, phenindione has been used since the 1980s, with annual sales estimated at approximately USD 500,000 before declining in recent years [3].

Patent and Commercialization Status

• Phenindione patents have long expired, leading to generic manufacturing.
• No recent significant R&D investments or new formulations have been announced, limiting revenue potential.

Regulatory Impact on Revenue

• Several European countries have withdrawn or restricted phenindione use in favor of safer alternatives [4].
• In India, regulatory agencies have not issued significant restrictions, but market penetration remains limited.

Future Outlook

• Limited product innovation suggests a continued decline unless a new formulation addresses safety concerns.
• Generic manufacturing continues to sustain minimal revenue streams but with no growth trajectory expected.

Investment Considerations

• Potential for niche market retention in regions with limited access to advanced anticoagulants.
• High safety risk profile makes significant investment or production expansion unlikely.
• In the context of rising awareness of bleeding risks with older anticoagulants, phenindione's market share faces pressure.

What Are the Key Market and Financial Trends?

Aspect	Detail	Data Source/Notes
Global Market Size	Less than USD 2 million/year	[2], industry estimates
Major Regions	India, parts of Europe	[3], [4]
Revenue	Declining trend	Historical sales data
Patent Status	Expired	Generic manufacturing
R&D Investment	Minimal	Industry reports
Competition	Warfarin, DOACs	Market share dominance

Key Takeaways

• Phenindione’s market is small and declining due to safety concerns and better alternatives.
• It remains in use predominantly in specific regions with limited access to newer anticoagulants.
• The financial outlook is bleak with limited opportunities for growth or significant revenue generation.
• Regulatory restrictions are increasingly limiting its use in many markets.
• Future development is unlikely without innovations addressing safety issues.

FAQs

1. Why has phenindione fallen out of favor compared to warfarin?
   It has a higher risk of bleeding and hepatotoxicity, along with less predictable anticoagulant effects, leading to decreased clinical preference.

2. Are there any ongoing clinical trials for phenindione?
   No significant trials are underway, and interest in the drug has waned due to safety concerns.

3. In which countries is phenindione still primarily used?
   Mainly in India and some Eastern European countries where newer options are less accessible or cost-prohibitive.

4. What are the main competitors for phenindione in the anticoagulant market?
   Warfarin and DOACs like apixaban, rivaroxaban, and dabigatran.

5. Is phenindione covered by any current patents?
   No, patents have expired, allowing generic manufacturing globally.

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References

[1] MarketWatch. "Global Anticoagulants Market." 2022.
[2] Industry estimates, 2022.
[3] Indian pharmaceutical market reports, 2021.
[4] European Medicines Agency reports, 2022.