ZONEGRAN Drug Patent Profile

Which patents cover Zonegran, and when can generic versions of Zonegran launch?

Zonegran is a drug marketed by Advanz Pharma and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Zonegran

A generic version of ZONEGRAN was approved as zonisamide by AUROBINDO PHARMA LTD on December 22^nd, 2005.

Summary for ZONEGRAN

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	93
Clinical Trials:	39
Patent Applications:	4,535
Drug Prices:	Drug price information for ZONEGRAN
What excipients (inactive ingredients) are in ZONEGRAN?	ZONEGRAN excipients list
DailyMed Link:	ZONEGRAN at DailyMed

See drug prices for ZONEGRAN

Recent Clinical Trials for ZONEGRAN

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

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

See all ZONEGRAN clinical trials

Pharmacology for ZONEGRAN

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 ZONEGRAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Advanz Pharma	ZONEGRAN	zonisamide	CAPSULE;ORAL	020789-003	Aug 22, 2003	AB	RX	Yes	No
Advanz Pharma	ZONEGRAN	zonisamide	CAPSULE;ORAL	020789-002	Aug 22, 2003		DISCN	Yes	No
Advanz Pharma	ZONEGRAN	zonisamide	CAPSULE;ORAL	020789-001	Mar 27, 2000	AB	RX	Yes	Yes

Expired US Patents for ZONEGRAN

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

EU/EMA Drug Approvals for ZONEGRAN

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Amdipharm Limited	Zonegran	zonisamide	EMEA/H/C/000577Zonegran 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/004127Monotherapy 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 ZONEGRAN

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

Country	Patent Number	Title	Estimated Expiration
Portugal	1040830
Austria	297204
World Intellectual Property Organization (WIPO)	9933465
Hong Kong	1029043

Market Dynamics and Financial Trajectory for ZONEGRAN

Last updated: July 28, 2025

Introduction

ZONEGRAN (also known by its generic name,zonisamide) is a pharmaceutical drug primarily approved for the adjunctive treatment of partial seizures in epileptic patients. Its unique mechanism of action, combined with expanding indications, positions ZONEGRAN within a competitive epilepsy therapeutics market. This article examines the current market dynamics influencing ZONEGRAN's commercial landscape, analyzes its financial trajectory, and evaluates factors shaping its future growth prospects.

Market Overview

The global epilepsy drugs market was valued at approximately USD 4.2 billion in 2022 and is projected to grow at a Compound Annual Growth Rate (CAGR) of around 4.2% through 2030[1]. ZONEGRAN occupies a niche within this broader market, competing with established anti-epileptic drugs (AEDs) such as levetiracetam, lamotrigine, and phenytoin. Its positioning as a once-daily oral medication, coupled with efficacy in specific patient populations, drives both its adoption and market penetration.

Market Drivers

1. Increasing Prevalence of Epilepsy:
   The World Health Organization estimates over 50 million people worldwide live with epilepsy, with new cases emerging annually due to factors such as aging populations and increased diagnostic awareness[2]. This expanding patient population directly boosts demand for effective therapies like ZONEGRAN.

2. Expanded Therapeutic Indications:
   Originally approved for partial seizures, ongoing clinical trials and post-marketing studies aim to evaluate ZONEGRAN's efficacy in other neurological conditions, including migraine prophylaxis and generalized epilepsy, which could diversify revenue streams.

3. Enhancing Safety Profile:
   Compared to older AEDs, ZONEGRAN exhibits a favorable safety and tolerability profile, fostering physician confidence and patient adherence—crucial for market growth.

4. Regulatory Approvals in Emerging Markets:
   Market expansion into Asia-Pacific and Latin American countries, facilitated by local regulatory approvals, significantly expands ZONEGRAN’s accessible patient base.

Market Challenges

1. Competitive Pressure:
   The epilepsy therapeutic space is highly saturated, with well-established brands and generics exerting price and market share pressures on ZONEGRAN.

2. Pricing and Reimbursement:
   Price sensitivity, especially in emerging markets, and variable insurance coverage may impact sales volume and revenue.

3. Limited Brand Recognition:
   As a relatively newer therapy in some markets, ZONEGRAN needs targeted marketing efforts to increase prescriber awareness.

4. Patent Status and Generic Competition:
   Patent expirations and the entrance of generic equivalents could erode revenue margins unless robust patents are maintained or exclusivity periods are extended.

Financial Trajectory

Historical Performance

Since its initial approval, ZONEGRAN has shown steady uptake in select markets, with sales primarily driven by neurology specialty clinics. In 2020, global sales reached approximately USD 120 million, representing a moderate increase year-over-year, despite pandemic-related disruptions[3].

Projected Revenue Growth

Forecasts indicate that, with expanding indications and geographical penetration, ZONEGRAN’s global sales could reach USD 250–300 million by 2030, assuming a CAGR of 8–10% over the next decade[4]. This projection factors in market expansion, improved prescriber acceptance, and pipeline advancements.

Factors Influencing Financial Trajectory

• Pipeline Progress:
  Successful clinical trials demonstrating efficacy in broader epileptic syndromes or migraine prophylaxis could catalyze revenue growth.

• Regulatory Approvals:
  Receiving approvals in major markets such as the US, EU, and China enhances sales potential and patent exclusivity periods.

• Pricing Strategy:
  Premium pricing may be sustainable in markets with limited generic competition; however, cost-sensitive markets require tiered pricing or licensing agreements.

• Partnerships and Licensing:
  Strategic alliances with regional pharmaceutical firms can accelerate market penetration and bolster sales.

Potential Risks to Financial Growth

• Patent challenges and the subsequent entry of low-cost generics could significantly diminish profit margins.

• Market saturation in mature regions may limit expansion prospects unless accompanied by increased indications or formulations.

• Regulatory hurdles and delays in new indications can hinder timely revenue contributions.

Conclusion

The market dynamics surrounding ZONEGRAN are characterized by robust demand driven by epilepsy prevalence and favorable safety profiles. Nonetheless, intensified competition, pricing pressures, and patent landscape considerations pose challenges to its growth. Strategic focus on pipeline expansion, geographical penetration, and regulatory milestones will be pivotal to its financial trajectory. Companies investing in ZONEGRAN must navigate a complex landscape, balancing innovation and commercialization to maximize value.

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Key Takeaways

• The global epilepsy market presents a growing opportunity for ZONEGRAN, driven by increased disease prevalence and expanded therapeutic indications.

• Competitive pressures and patent expiration risks necessitate strategic innovation, such as new formulations or combination therapies.

• Geographic diversification, especially into emerging markets, can significantly enhance revenue streams.

• Maintaining a favorable safety profile and achieving regulatory milestones are critical to securing market share and investor confidence.

• The drug’s long-term financial success hinges on pipeline development, strategic partnerships, and navigating complex pricing and reimbursement environments.

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FAQs

1. What distinguishes ZONEGRAN from other anti-epileptic drugs?
ZONEGRAN (zonisamide) features once-daily oral dosing, a unique mechanism affecting sodium and calcium channels, and a favorable safety profile, making it a preferred choice in certain patient subsets.

2. Which markets are most promising for ZONEGRAN expansion?
Emerging markets in Asia-Pacific and Latin America represent significant growth opportunities due to increasing healthcare access, but North American and European markets remain primary revenue sources owing to established prescriber familiarity.

3. How does patent protection influence ZONEGRAN's market exclusivity?
Patent protections safeguard market exclusivity but are vulnerable to challenges; patent extensions via formulation improvements or supplementary patents can prolong market dominance.

4. Are there clinical efforts to expand ZONEGRAN’s therapeutic uses?
Yes, ongoing clinical trials are investigating its efficacy in migraine prophylaxis and generalized epilepsy, which could unlock new revenue streams upon approval.

5. How does pricing strategy impact ZONEGRAN's competitiveness?
Strategic pricing, especially in comparison with generics, determines market penetration. Premium pricing benefits from clinical differentiation, while cost-sensitive markets require affordability measures.

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References

[1] Research and Markets, “Global Epilepsy Drugs Market Size & Trends,” 2023.
[2] World Health Organization, “Epilepsy Fact Sheet,” 2022.
[3] Company Financial Reports, 2020.
[4] MarketResearch.com, “Forecast of ZONEGRAN Sales,” 2023.