ZONISADE Drug Patent Profile

When do Zonisade patents expire, and when can generic versions of Zonisade launch?

Zonisade is a drug marketed by Azurity and is included in one NDA. There are two patents protecting this drug.

This drug has two patent family members in two countries.

The generic ingredient in ZONISADE is zonisamide. There are nineteen drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the zonisamide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Zonisade

A generic version of ZONISADE was approved as zonisamide by APOTEX INC on December 22^nd, 2005.

Summary for ZONISADE

International Patents:	2
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	122
Patent Applications:	4,217
Drug Prices:	Drug price information for ZONISADE
What excipients (inactive ingredients) are in ZONISADE?	ZONISADE excipients list
DailyMed Link:	ZONISADE at DailyMed

See drug prices for ZONISADE

Pharmacology for ZONISADE

Drug Class	Anti-epileptic Agent
Mechanism of Action	Carbonic Anhydrase Inhibitors P-Glycoprotein Inhibitors
Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

US Patents and Regulatory Information for ZONISADE

ZONISADE is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Azurity	ZONISADE	zonisamide	SUSPENSION;ORAL	214273-001	Jul 15, 2022		RX	Yes	Yes	11,478,456
Azurity	ZONISADE	zonisamide	SUSPENSION;ORAL	214273-001	Jul 15, 2022		RX	Yes	Yes	11,529,333		Y

EU/EMA Drug Approvals for ZONISADE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Amdipharm Limited	Zonegran	zonisamide	EMEA/H/C/000577 Zonegran is indicated as:monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy;adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adults, adolescents, and children aged six years and above.	Authorised	no	no	no	2005-03-10
Mylan Pharmaceuticals Limited	Zonisamide Mylan	zonisamide	EMEA/H/C/004127 Monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy;adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adults, adolescents, and children aged 6 years and above.	Authorised	yes	no	no	2016-03-31

International Patents for ZONISADE

See the table below for patents covering ZONISADE around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2019038584
European Patent Office	3668508	COMPOSITION PHARMACEUTIQUE ORALE COMPRENANT DU ZONISAMIDE ET SON PROCÉDÉ DE PRÉPARATION (AN ORAL PHARMACEUTICAL COMPOSITION COMPRISING ZONISAMIDE AND PROCESS OF PREPARATION THEREOF)

ZONISADE Market Analysis and Financial Projection

Zonisamide Market Dynamics and Financial Trajectory

Introduction to Zonisamide

Zonisamide, marketed under the brand name Zonegran, is a sulfonamide anticonvulsant and a carbonic anhydrase inhibitor used primarily to prevent and control seizures in patients with epilepsy. Here, we delve into the market dynamics and financial trajectory of zonisamide, highlighting key drivers, regional insights, and the competitive landscape.

Market Size and Growth Projections

The zonisamide market has been valued at USD 353.26 million in 2022 and is projected to grow at a Compound Annual Growth Rate (CAGR) of 3.9% through the forecast period[1][4].

Historical Data and Forecast

• Base Year: 2023
• Forecast Period: 2024-2030
• Historical Data: 2018 to 2023
• Market Size in 2023: USD 367.03 million
• Forecasted Market Size in 2030: USD 479.75 million[4].

Key Drivers of the Zonisamide Market

Increasing Prevalence of Epilepsy

Epilepsy is one of the most common neurological disorders globally, with approximately 50 million patients living with the condition and about 2.4 million new cases diagnosed annually. This increasing prevalence is a significant driver for the zonisamide market[4].

Effective Results of Second-Generation Antiepileptic Drugs

Second-generation antiepileptic drugs, including zonisamide, have shown effective results in managing seizures, making them a preferred choice among healthcare providers. This segment is expected to hold a large market share during the forecast period[4].

Personalized Medicine

The trend towards personalized medicine is impacting the market positively. Healthcare providers are increasingly tailoring treatment plans for epilepsy patients, often incorporating zonisamide as an adjunctive therapy for better seizure control and improved patient outcomes[3].

Expansion of Telemedicine

The expansion of telemedicine and online healthcare services has made it easier for individuals with epilepsy to access consultations and prescriptions for zonisamide, enhancing treatment accessibility[3].

Regional Insights

North America

North America dominates the zonisamide market with a significant share, primarily due to the increasing number of epileptic patients in the region. Around 3 million people in North America suffer from epilepsy, and the region has a well-developed healthcare infrastructure along with favorable government initiatives to improve healthcare[4].

Asia Pacific

The Asia Pacific region is expected to grow significantly during the forecast period, driven by increased government funding and support to improve treatment facilities in emerging markets and the rising disposable income of the population[4].

Market Segmentation

By Strength

The zonisamide market is segmented by strength into 25 mg, 50 mg, and 100 mg formulations. Each strength caters to different patient needs and is prescribed based on the severity of the condition and the patient's response to the medication[1][4].

By Application

The market is also segmented by application into adult, pediatric, and geriatric segments. The geriatric segment currently dominates the market and is predicted to rise rapidly due to the increased incidence and prevalence of epilepsy and seizures with aging[1][4].

Competitive Landscape

Key Players

The zonisamide market is characterized by the presence of several key players, including:

• Concordia
• Eisai
• Zydus Pharmaceuticals
• Sun Pharma
• Wockhardt
• Mylan
• APOTEX
• Teva
• Glenmark
• Bluepharma
• Invagen Pharmaceuticals
• Intas Pharmaceuticals[1].

These companies are involved in various strategies such as product launches, mergers and acquisitions, and research and development to maintain their market position.

Financial Performance and Projections

Revenue Growth

The revenue growth of the zonisamide market is steady, with a CAGR of 3.9% expected through the forecast period. This growth is driven by the increasing demand for effective antiepileptic drugs and the expanding patient base[1][4].

Regional Revenue Contribution

North America contributes significantly to the revenue, followed by Europe and the Asia Pacific. The regional revenue contribution is expected to shift slightly as emerging markets in the Asia Pacific region grow[4].

Challenges and Opportunities

Competition from Novel Antiepileptic Drugs

The emergence of novel antiepileptic drugs and treatment modalities has created competition within the market. However, this also drives ongoing research and development efforts to improve the efficacy and tolerability of zonisamide[3].

Regulatory Environment

Regulatory approvals and patent disputes can significantly impact the market. For instance, changes in patent exclusivity can affect the market share of key players[2].

Key Takeaways

• The zonisamide market is valued at USD 367.03 million in 2023 and is expected to grow at a CAGR of 3.9% through 2030.
• The increasing prevalence of epilepsy and the trend towards personalized medicine are key drivers.
• North America dominates the market, but the Asia Pacific region is expected to grow significantly.
• The market is segmented by strength and application, with the geriatric segment dominating.
• Key players are investing in research and development and strategic acquisitions to maintain market position.

FAQs

What is the current market size of zonisamide?

The zonisamide market was valued at USD 367.03 million in 2023[4].

What is the expected CAGR of the zonisamide market?

The zonisamide market is expected to grow at a CAGR of 3.9% through the forecast period[1][4].

Which region dominates the zonisamide market?

North America currently dominates the zonisamide market with a significant share[4].

What are the key drivers of the zonisamide market?

Key drivers include the increasing prevalence of epilepsy, effective results of second-generation antiepileptic drugs, and the trend towards personalized medicine[4].

Who are the key players in the zonisamide market?

Key players include Concordia, Eisai, Zydus Pharmaceuticals, Sun Pharma, and others[1].

Sources

1. Maximize Market Research: "Zonisamide Market Poised for Steady Growth with 3.9% CAGR"
2. UCB: "UCB on Growth Path for a Decade Plus"
3. IMARC Group: "Zonisamide (Zonegran) Manufacturing Plant Report 2024: Setup"
4. Maximize Market Research: "Zonisamide Market- Industry Analysis and Forecast"