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Last Updated: January 7, 2025

PROMPT PHENYTOIN SODIUM Drug Patent Profile


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When do Prompt Phenytoin Sodium patents expire, and when can generic versions of Prompt Phenytoin Sodium launch?

Prompt Phenytoin Sodium is a drug marketed by Ani Pharms and Watson Labs and is included in two NDAs.

The generic ingredient in PROMPT PHENYTOIN SODIUM is phenytoin sodium. There are twenty-one drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the phenytoin sodium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Prompt Phenytoin Sodium

A generic version of PROMPT PHENYTOIN SODIUM was approved as phenytoin sodium by HIKMA on December 31st, 1969.

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Summary for PROMPT PHENYTOIN SODIUM
Drug patent expirations by year for PROMPT PHENYTOIN SODIUM
Recent Clinical Trials for PROMPT PHENYTOIN SODIUM

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SponsorPhase
Shaheed Zulfiqar Ali Bhutto Medical UniversityN/A

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US Patents and Regulatory Information for PROMPT PHENYTOIN SODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ani Pharms PROMPT PHENYTOIN SODIUM phenytoin sodium CAPSULE;ORAL 080259-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Watson Labs PROMPT PHENYTOIN SODIUM phenytoin sodium CAPSULE;ORAL 080905-001 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

PROMPT PHENYTOIN SODIUM Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Prompt Phenytoin Sodium

Introduction

Phenytoin sodium, a crucial antiepileptic drug, has been a staple in the treatment of epilepsy and other seizure disorders for decades. This article delves into the market dynamics and financial trajectory of Prompt Phenytoin Sodium, highlighting key factors influencing its market position and future outlook.

Market Size and Growth

The global Phenytoin Sodium market is substantial, with a market size estimated at USD 86,984.2 million in 2024. This market is projected to grow at a compound annual growth rate (CAGR) of 9.20% from 2024 to 2031, reaching USD 161,064.1 million by 2031[3].

Regional Market Breakdown

The market is geographically diverse, with North America dominating, accounting for around 40% of the global revenue in 2024. Europe follows closely, holding more than 30% of the global revenue, while the Asia Pacific region is the fastest-growing, driven by increasing epilepsy prevalence and healthcare expenditure[3].

Drivers of Market Growth

Several factors drive the growth of the Phenytoin Sodium market:

  • Increasing Incidence of Epilepsy: The rising prevalence of epilepsy, particularly in developing countries, is a significant driver[3].
  • Technological Advancements: Improvements in drug formulations and delivery methods enhance the market's growth potential[3].
  • Regulatory Approvals: New indications beyond epilepsy and ongoing research in neurology contribute to market expansion[3].
  • Generic Formulations: The growing preference for generic formulations due to cost-effectiveness is another key driver[3].

Pricing Dynamics

The pricing of Phenytoin Sodium has been a subject of significant scrutiny. Historically, the prices of phenytoin sodium capsules saw a dramatic increase when Flynn Pharma commenced distribution in 2012. For example, the average selling price (ASP) for 100mg capsules rose from £2.21 to £51-£60.99, a hike of over 1,303%[1].

Impact of Dominant Market Positions

Companies like Pfizer and Flynn Pharma have maintained high prices due to their dominant market positions and the principle of Continuity of Supply, which ensures pharmacies prefer consistent suppliers over cheaper alternatives. This has resulted in a captive customer base for these companies, despite the availability of cheaper alternatives like NRIM’s phenytoin sodium capsules[1].

Competitive Landscape

The competitive landscape of the Phenytoin Sodium market is characterized by:

  • Dominant Players: Pfizer and Flynn Pharma have high market shares, allowing them to act independently of competitors and consumers[1].
  • Weak Competitive Constraints: Other formulations and parallel imports have not significantly constrained the pricing behavior of dominant players due to the principle of Continuity of Supply and limited availability of alternatives[1].
  • Generic Competition: Despite the dominance of a few players, generic competition is a significant restraint, as generic formulations are preferred for their cost-effectiveness[3].

Financial Implications

The financial trajectory of Prompt Phenytoin Sodium is influenced by several factors:

  • Revenue Growth: The market's projected CAGR of 9.20% indicates strong revenue growth potential[3].
  • Pricing Strategies: The ability of dominant players to maintain high prices despite generic competition and regulatory scrutiny affects the financial performance of the market[1].
  • Research and Development: Continuous investment in research and development to improve drug efficacy and safety profiles is crucial for maintaining market share and driving growth[3].

Challenges and Restraints

Despite the positive growth outlook, the market faces several challenges:

  • Regulatory Requirements: Stringent regulatory requirements for drug approval can slow market entry for new products[3].
  • Generic Competition: The preference for generic formulations can reduce the market share of branded products[3].
  • Limited Incentives for New Entrants: The principle of Continuity of Supply and the small, declining patient base for certain formulations can deter new entrants from investing in the market[1].

Future Outlook

The future of the Phenytoin Sodium market looks promising, driven by increasing epilepsy prevalence, technological advancements, and expanding healthcare access in emerging economies. Here are some key trends to watch:

  • Growing Preference for Generic Formulations: This trend is expected to continue, driven by cost-effectiveness and regulatory approvals[3].
  • Technological Advancements: Improvements in drug formulations and delivery methods will enhance market growth[3].
  • Expanding Healthcare Access: Increasing access to medical services in developing countries will drive demand for epilepsy treatments[3].

Key Takeaways

  • The global Phenytoin Sodium market is projected to grow significantly, driven by increasing epilepsy incidence and technological advancements.
  • Dominant players like Pfizer and Flynn Pharma have maintained high prices due to their market positions and the principle of Continuity of Supply.
  • Generic competition and stringent regulatory requirements are significant restraints.
  • The market is poised for steady growth, driven by ongoing research and expanding healthcare access.

FAQs

What is the current market size of the global Phenytoin Sodium market?

The global Phenytoin Sodium market size is estimated at USD 86,984.2 million in 2024[3].

What is the projected growth rate of the Phenytoin Sodium market from 2024 to 2031?

The market is projected to grow at a compound annual growth rate (CAGR) of 9.20% from 2024 to 2031[3].

Why did the prices of phenytoin sodium capsules increase significantly in 2012?

The prices increased significantly when Flynn Pharma commenced distribution in 2012, resulting in prices up to 23 times higher than Pfizer’s pre-2012 prices[1].

What are the main drivers of the Phenytoin Sodium market growth?

The main drivers include the increasing incidence of epilepsy, technological advancements, and the growing preference for generic formulations[3].

Which region is the fastest-growing in the Phenytoin Sodium market?

The Asia Pacific region is the fastest-growing, driven by increasing epilepsy prevalence, rising healthcare expenditure, and expanding access to medical services[3].

Sources

  1. Decision of the Competition and Markets Authority - GOV.UK
  2. Phenytoin Sodium, Prompt Prices, Coupons, Copay Cards & Patient Assistance - Drugs.com
  3. Global Phenytoin Sodium Market Report - Cognitive Market Research
  4. Comparison of pharmacokinetics and safety between CE-fosphenytoin sodium and fosphenytoin sodium - NCBI
  5. Dilantin (phenytoin sodium) - FDA.gov

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