ZONISAMIDE - Generic Drug Details

What are the generic drug sources for zonisamide and what is the scope of freedom to operate?

Zonisamide is the generic ingredient in three branded drugs marketed by Concordia, Ani Pharms, Apotex Inc, Aurobindo Pharma Ltd, Bionpharma, Epic Pharma Llc, Glenmark Pharms Inc, Granules, Heritage Pharma Avet, Invagen Pharms, Norvium Bioscience, Rising, Roxane, Sun Pharm Inds (in), Sun Pharm Industries, Unichem, Upsher Smith Labs, Zydus Lifesciences, and Azurity, and is included in twenty NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Zonisamide has two patent family members in two countries.

There are nineteen drug master file entries for zonisamide. Twenty suppliers are listed for this compound.

Summary for ZONISAMIDE

International Patents:	2
US Patents:	2
Tradenames:	3
Applicants:	19
NDAs:	20
Drug Master File Entries:	19
Finished Product Suppliers / Packagers:	20
Raw Ingredient (Bulk) Api Vendors:	122
Clinical Trials:	68
Patent Applications:	6,698
Drug Prices:	Drug price trends for ZONISAMIDE
Drug Sales Revenues:	Drug sales revenues for ZONISAMIDE
What excipients (inactive ingredients) are in ZONISAMIDE?	ZONISAMIDE excipients list
DailyMed Link:	ZONISAMIDE at DailyMed

See drug prices for ZONISAMIDE

See drug sales revenues for ZONISAMIDE

Recent Clinical Trials for ZONISAMIDE

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

Sponsor	Phase
Washington State University	Phase 2
The University of Akron	Phase 2
Washington University School of Medicine	Phase 2

See all ZONISAMIDE clinical trials

Pharmacology for ZONISAMIDE

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

Anatomical Therapeutic Chemical (ATC) Classes for ZONISAMIDE

N03AX	Other antiepileptics
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

US Patents and Regulatory Information for ZONISAMIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aurobindo Pharma Ltd	ZONISAMIDE	zonisamide	CAPSULE;ORAL	077645-001	Dec 22, 2005	AB	RX	No	No
Aurobindo Pharma Ltd	ZONISAMIDE	zonisamide	CAPSULE;ORAL	077645-003	Sep 29, 2006	AB	RX	No	No
Ani Pharms	ZONISAMIDE	zonisamide	CAPSULE;ORAL	077639-001	Dec 22, 2005		DISCN	No	No

Expired US Patents for ZONISAMIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Concordia	ZONEGRAN	zonisamide	CAPSULE;ORAL	020789-001	Mar 27, 2000

EU/EMA Drug Approvals for ZONISAMIDE

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 ZONISAMIDE

Country	Patent Number	Title	Estimated Expiration
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)
World Intellectual Property Organization (WIPO)	2019038584

ZONISAMIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Zonisamide

Introduction to Zonisamide

Zonisamide is an antiepileptic drug that has been increasingly prominent in the pharmaceutical market, particularly for the treatment of epilepsy and other neurological disorders. Here, we will delve into the market dynamics and financial trajectory of zonisamide.

Market Size and Growth Projections

The global zonisamide market has been experiencing significant growth. As of 2023, the market size was valued at USD 367.03 million and is expected to grow at a Compound Annual Growth Rate (CAGR) of 3.9% from 2024 to 2030, reaching USD 479.75 million by 2030[3][4].

Market Drivers

Several factors are driving the growth of the zonisamide market:

Growing Epilepsy Prevalence

The increasing prevalence of epilepsy worldwide is a major driver. With around 50 million people living with epilepsy globally and 2.4 million new cases diagnosed annually, the demand for effective antiepileptic drugs like zonisamide is on the rise[3][4].

Advances in Pharmaceutical Research

Continuous research and development have led to better formulations and administration systems, enhancing the effectiveness and patient compliance of zonisamide. These advancements make the drug more convenient and accessible[4].

Improved Diagnostic Tools

Better diagnostic instruments and greater knowledge about epilepsy enable earlier and more precise diagnoses, leading to more prescriptions for zonisamide[4].

Expanded Indications

Zonisamide is being investigated for the treatment of other neurological and mental disorders, such as bipolar disorder and Parkinson’s disease, which can significantly expand its market[4].

Healthcare Spending and Insurance

Increased healthcare spending and better insurance coverage allow more patients to afford and receive treatment with zonisamide[4].

Market Penetration in Developing Nations

Growing healthcare infrastructure, rising disposable incomes, and increasing awareness of epilepsy therapies in emerging markets, especially in Asia and Latin America, provide a prime location for market expansion[4].

Market Segmentation

The zonisamide market is segmented based on several criteria:

By Type

Zonisamide falls under the categories of antiepileptic drugs and carbonic anhydrase inhibitors[1].

By Application

The primary applications include epilepsy treatment, seizure control, and neuropathic pain management[1].

By Geography

North America dominates the market with a 30% share in 2023, followed by Europe, Asia-Pacific, and other regions. The Asia-Pacific region is expected to show significant growth due to increased government funding and improved healthcare infrastructure[3][4].

By Distribution Channel

The market is bifurcated into hospital pharmacies, retail pharmacies, and online pharmacies. Hospital pharmacies supply zonisamide to inpatients and outpatients, while retail and online pharmacies offer convenience and sometimes better pricing[4].

Financial Performance and Outlook

The financial trajectory of zonisamide is closely tied to the overall performance of the pharmaceutical companies that produce and market it.

Revenue Growth

The revenue from zonisamide sales is expected to grow steadily over the forecast period. The market's moderate growth rate is driven by the increasing demand for antiepileptic drugs and the expansion of zonisamide's indications[3][4].

Key Players

Companies like UCB, which has a strong portfolio of neurological treatments, play a significant role in the market. UCB's financial performance, though affected by losses of exclusivity for some products, shows resilience and growth driven by new product launches and strong performances of drugs like BRIVIACT® and FINTEPLA®[2].

Challenges and Opportunities

Challenges

• Patent Expiration: The expiration of zonisamide's patents could lead to the entry of generic equivalents, which may reduce the market share of branded versions[4].
• Regulatory Environment: Changes in regulatory policies can impact the market. However, favorable regulatory environments can also facilitate faster market entry and expansion[4].

Opportunities

• Emerging Markets: Growing healthcare infrastructure and awareness in emerging markets offer significant opportunities for expansion[4].
• Research and Development: Continuous R&D efforts can lead to better formulations and new indications, expanding the market further[4].

Regional Insights

North America

North America is the dominant region, driven by a well-developed healthcare infrastructure, favorable government initiatives, and extensive R&D activities. The antiepileptic drug market in North America was valued at US$ 7.97 billion in 2021[3].

Asia-Pacific

This region is expected to grow significantly due to increased government funding, improved healthcare infrastructure, and rising disposable incomes. Countries like India, China, and Japan are key markets in this region[3][4].

Key Takeaways

• The zonisamide market is growing at a CAGR of 3.9% from 2024 to 2030.
• Increasing epilepsy prevalence, advances in pharmaceutical research, and improved diagnostic tools are key drivers.
• North America dominates the market, but the Asia-Pacific region is expected to show significant growth.
• The market is segmented by type, application, geography, and distribution channel.
• Challenges include patent expiration and regulatory changes, while opportunities lie in emerging markets and R&D.

FAQs

What is the current market size of zonisamide?

The global zonisamide market was valued at USD 367.03 million in 2023[3].

What is the expected growth rate of the zonisamide market?

The market is expected to grow at a CAGR of 3.9% from 2024 to 2030[3].

Which region dominates the zonisamide market?

North America dominates the zonisamide market with a 30% share in 2023[3].

What are the primary applications of zonisamide?

The primary applications include epilepsy treatment, seizure control, and neuropathic pain management[1].

How does the expiration of patents affect the zonisamide market?

The expiration of patents could lead to the entry of generic equivalents, reducing the market share of branded versions but expanding overall market reach due to lower prices[4].

What are the key drivers of the zonisamide market?

Key drivers include the growing prevalence of epilepsy, advances in pharmaceutical research, improved diagnostic tools, and increased healthcare spending and insurance coverage[3][4].

Sources

1. Market Research Intellect: Global Zonisamide Sales Market Size, Scope And Forecast Report.
2. UCB USA: UCB on Growth Path for a Decade Plus.
3. Maximize Market Research: Zonisamide Market- Industry Analysis and Forecast.
4. Verified Market Research: In-Depth Industry Outlook : Zonisamide Market Size, Forecast.