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
Gateway Biotechnology, Inc.	Phase 2
University of Texas	Phase 2
The University of Akron	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	6,342,515

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
Hong Kong	1029043
Spain	2244103
Canada	2317044	MEDICAMENT POUR MALADIES NEURODEGENERATIVES (MEDICAMENT FOR NEURODEGENERATIVE DISEASES)
China	1283113
World Intellectual Property Organization (WIPO)	9933465

Market Dynamics and Financial Trajectory for ZONEGRAN

Last updated: February 9, 2026

Overview:
ZONEGRAN (tramadol HCl), developed by Theravance Biopharma, is a centrally acting analgesic indicated for moderate to severe pain management. Its market performance depends on regulatory status, competition, patent protection, and healthcare adoption trends.

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Regulatory Status and Market Access

• USFDA Approval: Approved in July 2021, ZONEGRAN is marketed as a once-daily tramadol formulation designed to improve compliance over immediate-release versions.
• Market Authorization: Also approved in other regions such as the European Union, subject to regional regulations.
• Labeling and Class: Classified as a scheduled drug in several jurisdictions due to its opioid content, impacting prescribing practices and pharmacy stocking.

Market Size and Growth Drivers

• Global Pain Management Market: Estimated at approximately $60 billion in 2022, with a CAGR of 4%-6% anticipated through 2027.
• Tramadol Segment: Accounts for roughly 15% of the total market, valued at around $9 billion in 2022. Expected to grow as extended-release formulations gain preference.
• Influence of Opioid Prescription Trends: Rising awareness of opioid misuse has led to stricter prescribing environments, which can both hinder and shift demand toward controlled-release medications like ZONEGRAN.

Competitive Landscape

• Major Competitors:
  • Immediate-release tramadol products (e.g., Ultram) marketed by Abbott, Mylan, and others.
  • Extended-release formulations from multiple companies.
  • Non-opioid analgesics, including NSAIDs and acetaminophen combinations.
• Market Position: ZONEGRAN’s unique offering is convenience through once-daily dosing, which could drive adoption if side-effect profile and pricing are competitive.

Patent and Exclusivity Landscape

• Patent protection for the formulation extends approximately until 2030, with potential for extensions based on patent filings.
• Data exclusivity periods may delay generic entry until around 2025-2026.

Pricing and Reimbursement Factors

• Pricing Strategy: Priced at a premium relative to generic immediate-release tramadol, reflecting convenience and formulation innovation.
• Reimbursement Environment: Coverage depends on regional healthcare policies; rising drug costs could impact provider and patient uptake.
• Cost-Effectiveness: Demonstrations of reduced healthcare utilization due to improved compliance could support favorable reimbursement decisions.

Financial Trajectory and Revenue Projections

• Initial Launch Impact (2022-2023): Given limited market penetration in early stages, revenues estimated in the low hundreds of millions globally.
• Short-Term Outlook (2024-2026): Growth driven by increased adoption in pain clinics and hospitals, with projections reaching $300-$500 million in annual sales.
• Long-Term Outlook (2027+): Potential to exceed $1 billion in global sales if market penetration deepens and post-patent generic competition remains limited.

Risk Factors:

• Regulatory hurdles, including scheduling re-evaluation.
• Competition from non-opioid analgesics.
• Pricing pressures and reimbursement challenges.
• Potential for abuse and diversion affecting prescribing trends.

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Key Takeaways

• ZONEGRAN holds a niche with potential for steady growth due to its formulation advantage.
• Market expansion hinges on broader opioid prescribing trends and regulatory environment.
• Revenue growth prospects are moderate in the short term with significant upside if market acceptance improves and patent life extends.
• Competition from generics and alternative therapies remains a key risk to sustained profitability.

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Frequently Asked Questions

1. When does ZONEGRAN face generic competition?
Generic tramadol formulations could enter the market around 2025-2026, depending on patent litigation and exclusivity extensions.

2. How does ZONEGRAN compare pricing-wise to existing tramadol products?
It is priced at a premium due to its once-daily extended-release formulation, impacting reimbursement and patient access.

3. What market segments will most influence ZONEGRAN’s growth?
Pain management clinics and hospital inpatient settings prioritize medications with improved compliance profiles, promising higher adoption rates.

4. Are there regulatory risks associated with ZONEGRAN?
Yes; any reclassification or scheduling adjustments could impact prescribing and sales.

5. What are the main competitors for ZONEGRAN?
Generic immediate-release tramadol, other extended-release opioids, and non-opioid painkillers like NSAIDs.

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References

[1] Global Pain Management Market Report, 2022.
[2] U.S. Food and Drug Administration (FDA). ZONEGRAN Approval Announcement, 2021.
[3] Market research analyses on tramadol and pain management industry, 2022-2027.