You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 22, 2024

PHENINDIONE - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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
Patent Applications: 5,221
DailyMed Link:PHENINDIONE at DailyMed
Recent Clinical Trials for PHENINDIONE

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

SponsorPhase
University of EdinburghPhase 3
NHS LothianPhase 3
Daiichi Sankyo, Inc.Phase 3

See all PHENINDIONE clinical trials

Medical Subject Heading (MeSH) Categories for PHENINDIONE
Anatomical Therapeutic Chemical (ATC) Classes for PHENINDIONE

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 ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

PHENINDIONE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Phenindione

Introduction

Phenindione, also known as Rectadione, is an anticoagulant that functions as a Vitamin K antagonist. To understand its market dynamics and financial trajectory, it is crucial to delve into its historical use, current market status, and the broader context of the pharmaceutical industry.

Historical Use and Mechanism of Action

Phenindione was introduced as an anticoagulant to prevent blood clotting. It works by inhibiting the synthesis of Vitamin K-dependent clotting factors, thereby reducing the risk of thrombosis and embolism[1].

Market Withdrawal and Regulatory Impact

While phenindione is not as widely discussed in recent market analyses as other anticoagulants, its historical context provides valuable insights. The withdrawal of drugs from the market, as seen with other pharmaceuticals like Redux and Pondimin, can significantly impact market dynamics. Although phenindione itself has not been subject to a high-profile market withdrawal, understanding the regulatory environment is essential. Regulatory actions, such as those by the FDA, can drastically alter the market landscape and financial trajectories of similar drugs[2].

Current Market Status

The current market for phenindione is relatively niche compared to newer anticoagulants. The global market research reports do not highlight phenindione as a major player in the anticoagulant market. Instead, the focus has shifted to more modern and safer alternatives. However, there is still a market for phenindione, particularly in regions where access to newer drugs is limited or where it is preferred due to specific clinical reasons[4].

Financial Trajectory

Historical Financials

The financial performance of phenindione in the past was likely tied to its widespread use as an anticoagulant. However, with the introduction of newer, safer anticoagulants, its market share and revenue have declined. The pharmaceutical industry is highly competitive, and the shift towards newer therapies has reduced the financial significance of older drugs like phenindione.

Current Revenue and Market Share

The current revenue from phenindione is not substantial compared to other anticoagulants. The market for anticoagulants has evolved significantly, with newer drugs capturing a larger share of the market. The dynamic changes in drug expenditure, as observed over the past two decades, indicate that older therapies like phenindione have seen a decline in importance and revenue[3].

Competitive Landscape

The anticoagulant market is highly competitive, with several newer drugs offering better safety profiles and efficacy. The competitive landscape is dominated by drugs like warfarin, apixaban, rivaroxaban, and others that have become the standard of care. Phenindione, being an older drug, faces significant competition from these newer agents.

Regulatory and Clinical Factors

Regulatory approvals and clinical guidelines play a crucial role in the market dynamics of any drug. For phenindione, any changes in clinical guidelines or regulatory approvals for newer anticoagulants can further reduce its market share. The FDA's stance on drug safety and efficacy also influences the financial trajectory of pharmaceuticals, including phenindione[2].

Global Market Trends

Global market trends in the pharmaceutical industry are characterized by continuous innovation and the introduction of new therapies. The shift towards precision medicine and personalized healthcare is also impacting the market. Companies like Phenomix Sciences, which focus on precision medicine for obesity and other conditions, are setting new standards for drug development and treatment. However, these trends do not directly benefit phenindione, as it is not part of the newer therapeutic classes[5].

Future Outlook

The future outlook for phenindione is limited due to the dominance of newer anticoagulants. While it may still be used in certain clinical scenarios or in regions with limited access to newer drugs, its overall market share and revenue are expected to continue declining.

Key Takeaways

  • Historical Use: Phenindione was introduced as an anticoagulant but has seen a decline in use with the introduction of newer, safer alternatives.
  • Regulatory Impact: Regulatory actions can significantly impact the market dynamics of pharmaceuticals, although phenindione has not been subject to a major market withdrawal.
  • Current Market Status: Phenindione is a niche player in the anticoagulant market, with limited revenue and market share.
  • Financial Trajectory: The financial performance of phenindione has declined with the introduction of newer anticoagulants.
  • Competitive Landscape: The anticoagulant market is highly competitive, dominated by newer drugs with better safety profiles and efficacy.
  • Future Outlook: The future outlook for phenindione is limited, with expected continued decline in market share and revenue.

FAQs

  1. What is the mechanism of action of phenindione? Phenindione functions as a Vitamin K antagonist, inhibiting the synthesis of Vitamin K-dependent clotting factors to prevent blood clotting[1].

  2. Why has the use of phenindione declined? The use of phenindione has declined due to the introduction of newer, safer anticoagulants that offer better efficacy and safety profiles.

  3. Is phenindione still used in clinical practice? Yes, phenindione may still be used in certain clinical scenarios or in regions with limited access to newer anticoagulants.

  4. How does the regulatory environment impact phenindione? Regulatory actions, such as FDA approvals and clinical guidelines, can influence the market dynamics and financial trajectory of phenindione, although it has not been subject to a major market withdrawal.

  5. What are the future prospects for phenindione in the pharmaceutical market? The future prospects for phenindione are limited, with expected continued decline in market share and revenue due to the dominance of newer anticoagulants.

Sources

  1. MedchemExpress.com - Phenindione (Rectadione)
  2. NBER.org - The Competitive Effects of Drug Withdrawals
  3. IQVIA.com - Understanding the Dynamics of Drug Expenditure
  4. GlobeNewswire.com - Phenindione (CAS 83-12-5) Global Market Research Report 2024
  5. PhenomixSciences.com - Media/Press - Phenomix Sciences

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.