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-one 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 APOTEX INC 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:	122
Clinical Trials:	39
Patent Applications:	5,021
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	020789-001	Mar 27, 2000	AB	RX	Yes	Yes
Advanz Pharma	ZONEGRAN	zonisamide	CAPSULE;ORAL	020789-002	Aug 22, 2003		DISCN	Yes	No
Advanz Pharma	ZONEGRAN	zonisamide	CAPSULE;ORAL	020789-003	Aug 22, 2003	AB	RX	Yes	No

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/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 ZONEGRAN

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

Country	Patent Number	Title	Estimated Expiration
Canada	2317044	MEDICAMENT POUR MALADIES NEURODEGENERATIVES (MEDICAMENT FOR NEURODEGENERATIVE DISEASES)
China	1283113
European Patent Office	1040830	REMEDE POUR MALADIES NEURODEGENERATIVES (REMEDY FOR NEURODEGENERATIVE DISEASES)
Germany	69830512
Portugal	1040830
South Korea	20010015890
Spain	2244103

Market Dynamics and Financial Trajectory for ZONEGRAN (Zonisamide)

Introduction to ZONEGRAN (Zonisamide)

ZONEGRAN, known generically as zonisamide, is an antiepileptic drug used primarily in the treatment of partial seizures. It is available in capsule form and has been approved for use in various countries, including the United States.

Market Size and Growth

The global zonisamide market is experiencing significant growth. As of 2023, the market size was substantial, and it is projected to continue growing at a moderate to high pace from 2024 to 2031. The compound annual growth rate (CAGR) for this period is expected to be notable, driven by increasing demand and expanding market reach[1][4].

Key Market Segments

Dosage Forms

The 25mg segment of zonisamide has accounted for a noticeable share of the global market and is expected to experience significant growth in the near future. This segment's growth is attributed to its efficacy and the preference of healthcare providers for this dosage[1].

Patient Demographics

The adult segment is a major driver of the zonisamide market, expected to expand at a significant CAGR throughout the forecast period. This growth is fueled by the increasing prevalence of epilepsy among adults and the effectiveness of zonisamide in treating partial seizures[1].

Market Drivers

Growing Healthcare Infrastructure

In developing nations, particularly in Asia and Latin America, the growing healthcare infrastructure, rising disposable incomes, and increasing awareness of epilepsy therapies are creating a prime environment for market expansion. These factors are expected to drive the demand for zonisamide in these regions[4].

Regulatory Acceptance

Regulatory approvals and support from agencies for the use of zonisamide in various applications are crucial for market growth. Faster drug approvals and favorable regulatory policies can facilitate quicker market entry and broader acceptance of the drug[4].

Generic Drugs and Patent Expiration

The expiration of patents for zonisamide is likely to lead to the introduction of generic equivalents, which can reduce the price of the medication and expand its market reach. Generic versions often increase accessibility and affordability, contributing to market growth[4].

Strategic Partnerships and Collaborations

Companies involved in the zonisamide market, such as Concordia and Zydus Pharmaceuticals, are focusing on strategic partnerships and collaborations to strengthen their product portfolios and expand their business. These strategies are essential for maintaining a competitive edge and driving growth[1].

Financial Performance

While specific financial data for ZONEGRAN alone is not readily available, the overall performance of companies involved in the antiepileptic drug market provides insights into the financial trajectory.

Revenue Growth

Companies like Jazz Pharmaceuticals, which operate in the broader neuroscience and oncology markets, have reported significant revenue growth. For instance, Jazz Pharmaceuticals saw a 27% year-over-year revenue increase in 2023, driven by key growth drivers including their neuroscience products. Although ZONEGRAN is not specifically mentioned, the growth in neuroscience revenues indicates a positive trend for antiepileptic drugs[2].

Cost and Pricing

The cost of product sales for companies in this sector can fluctuate based on factors such as acquisition costs and changes in product mix. However, the overall trend suggests that efficient cost management and strategic pricing can contribute to sustained revenue growth[5].

Clinical Efficacy and Market Impact

Clinical Trials and Efficacy

ZONEGRAN has demonstrated significant efficacy in clinical trials. Studies have shown that zonisamide reduces the frequency of partial seizures at various doses (100 mg/day to 400 mg/day) compared to placebo. For example, in one study, approximately 27% of patients treated with zonisamide experienced a 75% or greater reduction in seizure rate, compared to about 12% in the placebo group[3].

Market Acceptance

The clinical efficacy of zonisamide has led to its acceptance and use in the medical community. This acceptance is a key driver of market demand, as healthcare providers and patients seek effective treatments for epilepsy.

Competitive Landscape

The zonisamide market is competitive, with several key players focusing on expanding their market share. Companies like Concordia and Zydus Pharmaceuticals are actively engaged in strategy building and portfolio expansion to maintain their competitive positions[1].

Regulatory Environment

Favorable regulatory policies and approvals are crucial for the growth of the zonisamide market. Regulatory agencies' support for epilepsy treatment programs and faster drug approvals can significantly impact the market's expansion[4].

Future Outlook

The future outlook for the zonisamide market is positive, driven by increasing demand, expanding healthcare infrastructure, and strategic market initiatives. Here are some key points to consider:

• Growing Demand: The increasing prevalence of epilepsy and the effectiveness of zonisamide are expected to drive demand.
• Market Expansion: Emerging markets, especially in Asia and Latin America, offer significant growth opportunities.
• Generic Competition: The introduction of generic equivalents post-patent expiration could increase market reach and affordability.
• Regulatory Support: Favorable regulatory policies will continue to support market growth.

Key Takeaways

• The global zonisamide market is growing at a moderate to high pace.
• The 25mg segment and adult demographics are key drivers of market growth.
• Growing healthcare infrastructure and regulatory support are significant market drivers.
• Strategic partnerships and the introduction of generic equivalents will impact market dynamics.
• Clinical efficacy and market acceptance are crucial for sustained growth.

FAQs

What is ZONEGRAN (zonisamide) used for?

ZONEGRAN (zonisamide) is used primarily for the treatment of partial seizures in adults.

What is the expected growth rate of the zonisamide market?

The zonisamide market is expected to grow at a significant CAGR from 2024 to 2031, driven by increasing demand and market expansion.

Which regions are expected to drive the growth of the zonisamide market?

Emerging markets, particularly in Asia and Latin America, are expected to drive the growth of the zonisamide market due to growing healthcare infrastructure and increasing awareness of epilepsy therapies.

How does the expiration of patents affect the zonisamide market?

The expiration of patents for zonisamide is expected to lead to the introduction of generic equivalents, which can reduce the price of the medication and expand its market reach.

What role do regulatory policies play in the zonisamide market?

Regulatory policies and approvals are crucial for the growth of the zonisamide market, as they facilitate faster drug approvals and broader acceptance of the drug.

Sources

1. Global Zonisamide Market Report 2024 Edition - Cognitivemarketresearch.com
2. Jazz Pharmaceuticals Announces Full Year and Fourth Quarter 2023 Financial Results - Investor.jazzpharma.com
3. ZONEGRAN (zonisamide) capsules, for oral administration Rx Only - Accessdata.fda.gov
4. In-Depth Industry Outlook : Zonisamide Market Size, Forecast - Verifiedmarketresearch.com
5. Jazz Pharmaceuticals Announces Second Quarter 2024 Financial Results and Updates 2024 Financial Guidance - Prnewswire.com