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Last Updated: December 22, 2024

PHENYTOIN Drug Patent Profile


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Which patents cover Phenytoin, and what generic alternatives are available?

Phenytoin is a drug marketed by Actavis Mid Atlantic, Pai Holdings Pharm, Taro, Vistapharm, Epic Pharma Llc, Rising, Aurobindo Pharma, Pharmeral, Watson Labs, Acella, Am Regent, Fresenius Kabi Usa, Hikma, Hospira, Marsam Pharms Llc, Smith And Nephew, Solopak, and Warner Chilcott. and is included in twenty-three NDAs.

The generic ingredient in PHENYTOIN 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 Phenytoin

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

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Drug patent expirations by year for PHENYTOIN
Drug Prices for PHENYTOIN

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Drug Sales Revenue Trends for PHENYTOIN

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Recent Clinical Trials for PHENYTOIN

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SponsorPhase
TakedaPhase 1
Sohag UniversityPhase 2/Phase 3
Dr Cipto Mangunkusumo General HospitalPhase 4

See all PHENYTOIN clinical trials

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

US Patents and Regulatory Information for PHENYTOIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actavis Mid Atlantic PHENYTOIN phenytoin SUSPENSION;ORAL 089892-001 Sep 25, 1992 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Marsam Pharms Llc PHENYTOIN SODIUM phenytoin sodium INJECTABLE;INJECTION 089501-001 Oct 13, 1987 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Watson Labs PHENYTOIN SODIUM phenytoin sodium INJECTABLE;INJECTION 085434-001 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

PHENYTOIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Phenytoin

Introduction to Phenytoin

Phenytoin, an anticonvulsant drug, has been a cornerstone in the treatment of various types of seizures, including grand mal seizures, complex partial seizures, and seizures during or following neurosurgery, for over 80 years[3].

Global 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 expand at a compound annual growth rate (CAGR) of 9.20% from 2024 to 2031, reaching USD 161,064.1 million by 2031[1].

Key Drivers of Market Growth

Several factors are driving the growth of the Phenytoin Sodium market:

Increasing Incidence of Epilepsy

The rising prevalence of epilepsy worldwide, particularly in developing countries, is a significant driver. Better diagnostic techniques, aging populations, and lifestyle changes contributing to higher risk factors are all contributing to the increasing incidence of epilepsy[1].

Technological Advancements

Advancements in drug formulations and delivery methods are enhancing the market growth. These innovations improve the efficacy and safety profiles of phenytoin, making it more appealing to both patients and healthcare providers[1].

Regulatory Approvals and Generic Formulations

Regulatory approvals for new indications beyond epilepsy and the growing preference for generic formulations due to their cost-effectiveness are also boosting market growth. Generic formulations increase accessibility and affordability, especially in emerging economies[1].

Regional Market Dynamics

North America

North America dominated the market in 2024, accounting for around 40% of the global revenue. This dominance is attributed to a high prevalence of epilepsy, advanced healthcare infrastructure, and significant pharmaceutical R&D investments in the region[1].

Asia Pacific

The Asia Pacific region is the fastest-growing market for Phenytoin Sodium. Factors such as increasing epilepsy prevalence, rising healthcare expenditure, and expanding access to medical services are driving this growth. Economic growth and healthcare reforms in countries like China and India further enhance market potential[1].

Latin America and Middle East & Africa

Latin America and the Middle East & Africa also hold significant market shares, with Latin America accounting for more than 5% of the global revenue and the Middle East & Africa holding around 2%. These regions are expected to grow at CAGRs of 8.6% and 8.9%, respectively, from 2024 to 2031[1].

Financial Trajectory

Revenue Projections

The global Phenytoin Sodium market is expected to see significant revenue growth, from USD 86,984.2 million in 2024 to USD 161,064.1 million by 2031. This growth is driven by the increasing demand for effective epilepsy treatments and the expanding healthcare access in emerging economies[1].

Cost-Effectiveness

Phenytoin remains a cost-effective option compared to other anticonvulsants. For instance, a cost-minimization analysis showed that phenytoin had an expected total treatment cost of $5.39 compared to $110.14 for fosphenytoin, highlighting its economic advantages[2].

Challenges and Restraints

Generic Competition

Despite its growth, the Phenytoin Sodium market faces challenges such as generic competition. The availability of generic formulations can reduce the market share of branded products, although it also increases overall accessibility[1].

Regulatory Requirements

Stringent regulatory requirements for drug approval are another significant restraint. These regulations can delay market entry for new formulations and indications, affecting overall market growth[1].

Phenytoin Testing Market

The global phenytoin testing market, which is closely related to the use of phenytoin, is also growing. This market is estimated to garner a revenue of about USD 8 billion by the end of 2033, growing at a CAGR of ~2% over the forecast period. The rise in incidences of phenytoin toxicity and the need for continuous monitoring are key drivers of this market[4].

Conclusion

The Phenytoin Sodium market is poised for steady growth driven by the increasing incidence of epilepsy, technological advancements, and expanding healthcare access. While it faces challenges such as generic competition and stringent regulatory requirements, the market's financial trajectory indicates a strong and growing demand for this essential anticonvulsant drug.

Key Takeaways

  • The global Phenytoin Sodium market size was estimated at USD 86,984.2 million in 2024 and is expected to reach USD 161,064.1 million by 2031.
  • The market is driven by the increasing prevalence of epilepsy and technological advancements in drug formulations.
  • North America dominates the market, while the Asia Pacific region is the fastest-growing.
  • Generic competition and stringent regulatory requirements are significant restraints.
  • The global phenytoin testing market is also growing, driven by the need to monitor phenytoin levels and detect toxicity.

FAQs

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

The global Phenytoin Sodium market size was estimated at USD 86,984.2 million in 2024[1].

What is the projected CAGR for the Phenytoin Sodium market from 2024 to 2031?

The market is expected to expand at a CAGR of 9.20% from 2024 to 2031[1].

Which region dominates the Phenytoin Sodium market?

North America dominates the market, accounting for around 40% of the global revenue in 2024[1].

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

Key drivers include the increasing incidence of epilepsy, technological advancements in drug formulations, and expanding healthcare access in emerging economies[1].

What are the challenges facing the Phenytoin Sodium market?

Challenges include generic competition and stringent regulatory requirements for drug approval[1].

Sources:

  1. Cognitive Market Research - Global Phenytoin Sodium Market Report 2024
  2. PubMed - Cost-minimization analysis of phenytoin and fosphenytoin
  3. DrugBank Online - Phenytoin: Uses, Interactions, Mechanism of Action
  4. Kenneth Research - Global Phenytoin Testing Market Size, Share, Growth, Trends & Global Forecast 2023-2033

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