PHENYTOIN SODIUM - Generic Drug Details

What are the generic sources for phenytoin sodium and what is the scope of patent protection?

Phenytoin sodium is the generic ingredient in seven branded drugs marketed by Viatris, Chartwell Molecular, Amneal Pharms Ny, Ani Pharms, Lupin Ltd, Mylan, Sun Pharm Inds, Sun Pharm Inds (in), Taro, Unichem, Wockhardt, Wockhardt Usa, Watson Labs, Aurobindo Pharma, Pharmeral, Parke Davis, Acella, Am Regent, Fresenius Kabi Usa, Hikma, Hospira, Marsam Pharms Llc, Smith And Nephew, Solopak, and Warner Chilcott, and is included in thirty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are eighteen drug master file entries for phenytoin sodium. Twenty-five suppliers are listed for this compound.

Summary for PHENYTOIN SODIUM

US Patents:	0
Tradenames:	7
Applicants:	25
NDAs:	33
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	25
Raw Ingredient (Bulk) Api Vendors:	193
Clinical Trials:	20
Patent Applications:	6,250
What excipients (inactive ingredients) are in PHENYTOIN SODIUM?	PHENYTOIN SODIUM excipients list
DailyMed Link:	PHENYTOIN SODIUM at DailyMed

See drug sales revenues for PHENYTOIN SODIUM

Recent Clinical Trials for PHENYTOIN SODIUM

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

Sponsor	Phase
Shaheed Zulfiqar Ali Bhutto Medical University	N/A
Industria Farmacêutica Health Meds	Phase 4
Hospital Israelita Albert Einstein	Phase 4

See all PHENYTOIN SODIUM clinical trials

Pharmacology for PHENYTOIN SODIUM

Drug Class	Anti-epileptic Agent
Mechanism of Action	Cytochrome P450 1A2 Inducers Cytochrome P450 2B6 Inducers Cytochrome P450 2C19 Inducers Cytochrome P450 2C8 Inducers Cytochrome P450 2C9 Inducers Cytochrome P450 2D6 Inducers Cytochrome P450 3A Inducers
Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Anatomical Therapeutic Chemical (ATC) Classes for PHENYTOIN SODIUM

N03AB	Hydantoin derivatives
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

US Patents and Regulatory Information for PHENYTOIN SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Wockhardt	EXTENDED PHENYTOIN SODIUM	phenytoin sodium	CAPSULE;ORAL	040759-001	Dec 18, 2007		DISCN	No	No
Unichem	EXTENDED PHENYTOIN SODIUM	phenytoin sodium	CAPSULE;ORAL	213834-001	Oct 13, 2022		DISCN	No	No
Chartwell Molecular	DIPHENYLAN SODIUM	phenytoin sodium	CAPSULE;ORAL	080857-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Pharmeral	PHENYTOIN SODIUM	phenytoin sodium	CAPSULE;ORAL	085435-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Taro	EXTENDED PHENYTOIN SODIUM	phenytoin sodium	CAPSULE;ORAL	040684-001	Sep 5, 2006	AB	RX	No	No
Acella	PHENYTOIN SODIUM	phenytoin sodium	INJECTABLE;INJECTION	040573-001	Sep 13, 2006	AP	RX	No	No
Mylan	PHENYTEK	phenytoin sodium	CAPSULE;ORAL	040298-003	Dec 6, 2001	AB	RX	No	Yes

PHENYTOIN SODIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Phenytoin Sodium

Global Market Size and Growth

The global phenytoin sodium market is substantial and growing, 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

Several factors drive the growth of the phenytoin sodium market:

Increasing Prevalence of Epilepsy

The rising incidence of epilepsy worldwide, particularly in developing countries, is a significant driver. As the global population grows and healthcare access improves, the demand for effective epilepsy treatments like phenytoin sodium increases[1].

Technological Advancements

Advancements in drug formulations and delivery methods enhance the market growth. For instance, techniques like inclusion complexation using beta-cyclodextrin have improved the solubility and dissolution rate of phenytoin sodium, making it more effective[5].

Regulatory Approvals

Regulatory approvals for new indications beyond epilepsy and ongoing research in neurology contribute to market expansion. These approvals open up new markets and patient segments for phenytoin sodium[1].

Market Segmentation

The phenytoin sodium market is segmented based on several criteria:

By Application

• Epilepsy Treatment: This is the primary application, driving the majority of the market demand.
• Nerve Analgesia: Phenytoin sodium is also used for nerve pain management, though this segment is smaller compared to epilepsy treatment[4].

By Product

• Pill: Oral formulations are the most common.
• Injection: Parenteral forms are used in acute settings or when oral administration is not feasible[4].

By Geography

• North America: Dominates the market with around 40% of global revenue, driven by high epilepsy prevalence, advanced healthcare infrastructure, and significant pharmaceutical R&D investments[1].
• Asia Pacific: The fastest-growing region, driven by increasing epilepsy prevalence, rising healthcare expenditure, and expanding access to medical services. Countries like China and India are key contributors to this growth[1].
• Latin America: Accounts for more than 5% of the global revenue, with a CAGR of 8.6% from 2024 to 2031[1].
• Middle East and Africa: Holds around 2% of the global revenue, with a CAGR of 8.9% from 2024 to 2031[1].

Challenges and Restraints

Despite the growth, the market faces several challenges:

Generic Competition

The availability of generic versions of phenytoin sodium is a significant restraint. Generic drugs offer the same therapeutic benefits at lower costs, reducing the pricing power and market share of branded drugs. This leads to price erosion and impacts the revenue potential of branded products[1].

Regulatory Requirements

Stringent regulatory requirements for drug approval can slow market growth. Pharmaceutical companies must navigate complex approval processes, which can delay product launches and limit market access[1].

Pricing Issues

Historical instances of unfair pricing practices, such as those involving Pfizer and Flynn in the UK, have led to significant regulatory scrutiny. These practices resulted in substantial price increases, which were later deemed excessive and led to legal actions[2].

Financial Impact

The financial trajectory of the phenytoin sodium market is influenced by several factors:

Revenue Growth

The market is expected to grow significantly, driven by increasing demand and expanding healthcare access. The CAGR of 9.20% from 2024 to 2031 indicates a robust financial outlook[1].

Profit Margins

However, profit margins are under pressure due to generic competition. The preference for generic drugs by healthcare providers and insurers reduces the pricing power of branded drugs, leading to lower profit margins for pharmaceutical companies[1].

Regional Variations

Regional variations in market size and growth rates also impact the financial trajectory. For example, the Asia Pacific region is expected to grow at a CAGR of 11.2%, while Latin America and the Middle East and Africa will grow at CAGRs of 8.6% and 8.9%, respectively[1].

Technological and Formulation Advancements

Technological advancements play a crucial role in enhancing the financial performance of the market:

Enhanced Solubility

Studies have shown that techniques like inclusion complexation can significantly improve the solubility of phenytoin sodium, leading to better drug release profiles and potentially higher patient compliance. This can drive higher sales and revenue[5].

Optimized Formulations

Optimized formulations, such as chewable tablets developed using 22 factorial design, can improve the drug's efficacy and patient acceptance. Such innovations can help maintain market share and profitability in the face of generic competition[5].

Key Takeaways

• The global phenytoin sodium market is projected to grow at a CAGR of 9.20% from 2024 to 2031.
• Increasing epilepsy prevalence and technological advancements are key drivers.
• Generic competition and stringent regulatory requirements are significant restraints.
• Regional markets, especially Asia Pacific, are expected to drive growth.
• Technological advancements in drug formulations are crucial for maintaining market share and profitability.

FAQs

What is the current global market size of phenytoin sodium?

The global phenytoin sodium market size is 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 grow 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[1].

What are the main challenges facing the phenytoin sodium market?

Generic competition and stringent regulatory requirements are significant challenges[1].

How do technological advancements impact the phenytoin sodium market?

Technological advancements, such as inclusion complexation, enhance the solubility and efficacy of phenytoin sodium, potentially driving higher sales and revenue[5].

Sources

1. Cognitive Market Research: Global Phenytoin Sodium Market Report 2024.
2. UK Government: Decision - Unfair pricing in respect of the supply of phenytoin.
3. NCBI Bookshelf: Phenytoin - Some Pharmaceutical Drugs.
4. Market Research Intellect: Global Phenytoin Sodium Market Size and Forecast.
5. IJPS: Synthesis and Formulation Development of Phenytoin by Inclusion Complexation.