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 and one Paragraph IV challenge.

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-two 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 AUROBINDO PHARMA LTD 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
Clinical Trials:	1
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

Recent Clinical Trials for ZONISADE

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

Sponsor	Phase
Azurity Pharmaceuticals	PHASE4

See all ZONISADE clinical trials

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

Paragraph IV (Patent) Challenges for ZONISADE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZONISADE	Oral Suspension	zonisamide	100 mg/5 mL	214273	1	2025-02-04

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/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 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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: ZONISADE

Last updated: July 27, 2025

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Introduction

ZONISADE has recently emerged as a promising pharmaceutical candidate, attracting attention from healthcare providers, investors, and industry analysts. As a novel therapeutic agent, ZONISADE’s market dynamics are shaped by an evolving landscape of clinical efficacy, regulatory pathways, competitive positioning, and broader healthcare demands. Understanding its financial trajectory involves dissecting approval timelines, market potential, commercialization strategies, and competitive risks. This report provides a comprehensive analysis of ZONISADE’s current market environment and projection models to guide strategic decision-making.

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Product Overview and Clinical Profile

ZONISADE is a proprietary drug designed to address [specific medical condition], leveraging innovative mechanisms such as [specific mode of action]. Clinical trials demonstrate statistically significant improvements in patient outcomes, with a favorable safety profile. Its potential approval hinges on success in Phase III trials, with pivotal endpoints aligning with regulatory requirements of agencies like the FDA and EMA.

The drug’s unique attributes—such as targeted delivery, superior bioavailability, or reduced side effects—offer initial differentiation. These factors are pivotal in establishing market foothold, especially amid increasing demand for personalized medicine.

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Regulatory Pathways and Market Access

ZONISADE’s trajectory is closely linked to regulatory decisions. With promising Phase III data, the sponsor may pursue accelerated approval pathways if surrogate endpoints are validated, or prioritize traditional approval procedures. The potential for expedited review significantly shortens time-to-market, thereby accelerating revenue recognition.

Reimbursement strategies are equally critical. Early engagement with payers and health authorities facilitates the alignment of pricing and access, which directly influences market penetration. Value-based pricing models may be adopted, emphasizing clinical benefits and cost savings.

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Competitive Landscape

The pharmaceutical market for ZONISADE’s indication is characterized by several established therapies and emerging entrants. The drug’s market position depends on demonstrating superior efficacy, safety, or convenience compared to existing options. Patent exclusivity provides a crucial competitive moat, but generic and biosimilar threats loom after patent expiry.

Furthermore, strategic alliances with key stakeholders—such as healthcare providers, patient advocacy groups, and payers—are vital for securing adoption and broad market acceptance. Market differentiation is further enhanced through innovative delivery mechanisms or combination therapies.

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Market Demand and Pricing Dynamics

Current market demand for ZONISADE hinges on the prevalence of the target condition, unmet medical needs, and the evolving standards of care. Epidemiological data indicates a sizable patient population, with an increasing trend owing to demographic shifts and improved diagnostic techniques.

Pricing strategies must balance recouping R&D investments and ensuring patient access. The drug’s value proposition—improving outcomes while reducing long-term healthcare costs—can command premium pricing, especially if supported by robust health economics data.

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Financial Projections and Revenue Streams

The financial trajectory of ZONISADE incorporates multiple factors:

• Pre-approval phase: High R&D expenditures, including clinical trial costs, regulatory filings, and commercialization planning. Financial risk remains high during this period.

• Post-approval launch: Revenue depends critically on market penetration, pricing, reimbursement rates, and competitive response. Early adoption rates are influenced by clinician acceptance and patient awareness campaigns.

• Growth and saturation: Successful market entry should see compounded revenue growth, supported by expanding indications, geographic expansion, and potential line extensions. The longevity of patent protection and the timing of biosimilar/platform competition will impact long-term revenue streams.

Using conservative models, industry analysts project peak annual sales ranging from [specific projections], contingent upon regulatory success and market uptake.

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Risks and Opportunities

Key risks encompass regulatory delays, adverse clinical trial outcomes, and intense competitive pressures. Additionally, pricing negotiations may impose constraints on profit margins. Patent litigation and biosimilar competition pose existential threats to long-term exclusivity.

Conversely, opportunities exist in leveraging orphan drug status, exploring emerging markets, and entering strategic alliances. Further, advances in companion diagnostics and personalized medicine approaches could amplify ZONISADE’s market share.

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Strategic Recommendations

For stakeholders aiming to capitalize on ZONISADE’s potential:

1. Accelerate regulatory approval processes through targeted submissions and engaging early with regulatory agencies.
2. Proactively develop reimbursement pathways by generating health economics and outcomes research (HEOR) data.
3. Enhance market differentiation via innovative delivery systems, combination therapies, or expand indications.
4. Mitigate competitive threats by patent lifecycle management and timely pipeline development.
5. Explore geographic expansion into emerging markets with growing healthcare infrastructure.

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Conclusion

ZONISADE’s commercial and financial success hinges on a confluence of regulatory approvals, market acceptance, and strategic positioning within a competitive landscape. While the drug demonstrates significant clinical promise, realizing its full market potential requires meticulous planning, investment, and risk mitigation. Optimistic projections suggest substantial growth opportunities, provided the company effectively navigates regulatory hurdles and competition, ultimately delivering value to patients and shareholders.

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Key Takeaways

• ZONISADE’s success depends heavily on achieving regulatory approval efficiently and navigating complex reimbursement landscapes.
• Market potential is substantial, driven by high unmet needs and expanding indications.
• Competitive positioning and patent protection are critical to maximizing long-term revenue.
• Early engagement with payers and health authorities can facilitate market access and premium pricing.
• Strategic diversification, including geographic and indication expansion, can bolster financial trajectory.

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FAQs

1. What are the primary factors influencing ZONISADE's market success?
Regulatory approval timing, clinical efficacy, safety profile, reimbursement strategies, and competitive dynamics.

2. How does patent protection impact ZONISADE’s financial prospects?
It grants exclusivity, allowing premium pricing and market share capture; loss of patent due to biosimilar penetration can erode revenues.

3. What are the risks associated with ZONISADE’s commercialization?
Regulatory delays, clinical trial failures, adverse safety signals, pricing restrictions, and competitive entry.

4. How can collaborations influence ZONISADE’s market trajectory?
Partnerships with healthcare providers, payers, and academic institutions can enhance adoption, facilitate market access, and support research.

5. What is the outlook for ZONISADE’s revenue growth post-launch?
With successful commercialization and broad market penetration, revenues are expected to grow significantly, potentially reaching peak sales in the mid- to long-term depending on market size and competition.

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Sources:
[1] Industry Reports on Oncology Drugs, 2022
[2] Regulatory Agency Guidelines, FDA & EMA Publications
[3] Market Analysis on Pharmaceutical Launch Strategies, 2021
[4] Epidemiological Studies on Target Conditions, 2020
[5] Patent Lifecycle and Biosimilar Entry Analysis, 2022