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Last Updated: December 22, 2024

PHENYTEK Drug Patent Profile


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When do Phenytek patents expire, and what generic alternatives are available?

Phenytek is a drug marketed by Mylan and is included in one NDA.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Phenytek

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

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US Patents and Regulatory Information for PHENYTEK

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan PHENYTEK phenytoin sodium CAPSULE;ORAL 040298-002 Dec 6, 2001 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Mylan PHENYTEK phenytoin sodium CAPSULE;ORAL 040298-003 Dec 6, 2001 AB RX No Yes ⤷  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

PHENYTEK Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Antiepileptic Drugs: A Focus on Phenytoin

Introduction

Antiepileptic drugs (AEDs) are a crucial segment of the pharmaceutical industry, with a growing market driven by increasing prevalence of epilepsy and advancements in treatment options. This article will delve into the market dynamics and financial trajectory of AEDs, with a specific focus on phenytoin, a well-established anticonvulsant drug.

Global Antiepileptic Drugs Market Overview

The global antiepileptic drugs market is projected to grow significantly, from $17.13 billion in 2024 to $24.85 billion by 2032, at a Compound Annual Growth Rate (CAGR) of 4.8%[1].

Market Segmentation

By Geography

North America dominates the global AED market, with a share of 48.3% in 2023. The U.S. market alone is expected to reach $10.03 billion by 2032, driven by high diagnosis and treatment rates, adequate reimbursement policies, and heightened awareness among patients[1].

Europe and the Asia Pacific are also expected to exhibit a higher CAGR during the forecast period, driven by regulatory approvals and the penetration of key regional players. Latin America and the Middle East & Africa are anticipated to witness growth due to developing healthcare infrastructure and increasing prevalence of epilepsy[1].

By Distribution Channel

Hospital pharmacies hold the dominant share of the market due to advanced infrastructure, adequate facilities, and favorable reimbursement policies. Retail pharmacies and online pharmacies also contribute significantly, with the latter expected to grow due to the rising preference for teleconsultation and online pharmacy services[1].

Key Players in the AED Market

Prominent players such as UCB S.A., Pfizer Inc., and GSK plc. dominate the global market. Pfizer's strong product portfolio, including the drug Lyrica, has been a key factor in its market dominance. However, the patent expiration of Lyrica in 2019 has led to a decline in its share, as generics have entered the market[1].

Phenytoin: A Historical and Current Perspective

Historical Context

Phenytoin, also known as phenytoin sodium, has been a staple in the treatment of epilepsy since its introduction. Despite its long history, it has faced challenges such as declining sales in some regions. For instance, worldwide sales of phenytoin decreased by approximately 8% from 1990 to 1995, although U.S. prescriptions increased by about 10% during the same period[2].

Clinical Use and Side Effects

Phenytoin is administered orally or intravenously and is known for its high bioavailability and protein binding. However, it has been associated with side effects such as lymph node reactions and, in rare cases, lymphomas and leukemias. These side effects, although rare, have been a subject of clinical concern[2][5].

Market Size and Growth

The global phenytoin sodium market size is estimated to be around $86,984.2 million in 2024 and is expected to grow to $161,064.1 million by the end of the forecast period, driven by the increasing incidence of epilepsy[4].

Financial Trajectory of Phenytoin

Revenue Projections

The revenue from phenytoin is expected to increase due to the growing demand for AEDs. The market size of phenytoin sodium is projected to nearly double by the end of the forecast period, indicating a strong financial trajectory for this drug[4].

Competitive Landscape

While phenytoin remains a significant player, the market is becoming increasingly competitive with the introduction of new and innovative AEDs. Companies like UCB S.A., Pfizer, and GSK plc. are investing heavily in research and development to launch novel medications, which could impact the market share of traditional drugs like phenytoin[1].

Factors Driving Market Growth

Increasing Prevalence of Epilepsy

The rising incidence of epilepsy globally is a key driver for the AED market, including phenytoin. As more people are diagnosed and treated, the demand for effective anticonvulsant drugs increases[1][4].

Regulatory Approvals and Government Initiatives

Active government initiatives to spread awareness and regulatory approvals for new drugs are crucial factors driving market growth. The increasing number of drugs receiving regulatory approvals, especially in regions like Europe and the Asia Pacific, is expected to boost the demand for AEDs[1].

Advancements in Healthcare Infrastructure

Developing healthcare infrastructure in regions like Latin America and the Middle East & Africa is expected to fuel the demand for AEDs, including phenytoin. Better access to healthcare facilities and advanced treatment options are key to this growth[1].

Challenges and Opportunities

Patent Expirations and Generics

The expiration of patents for major AEDs, such as Lyrica, has led to the entry of generics into the market. This trend is expected to continue, posing a challenge to branded drugs like phenytoin but also presenting opportunities for generic manufacturers[1].

Online Pharmacies and Teleconsultation

The growing preference for teleconsultation and online pharmacy services presents an opportunity for the AED market. Online pharmacies can increase accessibility and convenience for patients, potentially boosting sales for drugs like phenytoin[1].

Key Takeaways

  • The global antiepileptic drugs market is projected to grow from $17.13 billion in 2024 to $24.85 billion by 2032.
  • North America dominates the market, driven by high diagnosis and treatment rates and adequate reimbursement policies.
  • Phenytoin, despite historical challenges, remains a significant player in the AED market with a projected market size of $161,064.1 million by the end of the forecast period.
  • Increasing prevalence of epilepsy, regulatory approvals, and advancements in healthcare infrastructure are key drivers of market growth.
  • The market is becoming increasingly competitive with the introduction of new and innovative AEDs.

FAQs

Q: What is the projected growth rate of the global antiepileptic drugs market from 2024 to 2032? A: The global antiepileptic drugs market is projected to grow at a CAGR of 4.8% from 2024 to 2032[1].

Q: Which region dominates the global antiepileptic drugs market? A: North America dominates the global antiepileptic drugs market, with a share of 48.3% in 2023[1].

Q: What are the key factors driving the growth of the phenytoin sodium market? A: The increasing incidence of epilepsy, regulatory approvals, and advancements in healthcare infrastructure are key factors driving the growth of the phenytoin sodium market[4].

Q: How does the patent expiration of major AEDs impact the market? A: The patent expiration of major AEDs leads to the entry of generics into the market, posing a challenge to branded drugs but presenting opportunities for generic manufacturers[1].

Q: What role do online pharmacies play in the AED market? A: Online pharmacies increase accessibility and convenience for patients, potentially boosting sales for drugs like phenytoin due to the growing preference for teleconsultation and online pharmacy services[1].

Sources

  1. Fortune Business Insights: Antiepileptic Drugs [AED] Market Size, Trends | Forecast, 2032.
  2. NCBI Bookshelf: Phenytoin - Some Pharmaceutical Drugs.
  3. Goldman Sachs: Weighing the GLP-1 market.
  4. Cognitive Market Research: Global Phenytoin Sodium market size.
  5. Wikipedia: Phenytoin.

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