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Last Updated: April 16, 2024

Zonisamide - Generic Drug Details

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What are the generic 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 Generics, Granules, Heritage Pharma Avet, Invagen Pharms, Mylan Pharms Inc, 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:	6,870
Formulation / Manufacturing:	see details
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

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Drug Sales Revenue Trends 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
Gateway Biotechnology, Inc.	Phase 2
University of Texas	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

US Patents and Regulatory Information for zonisamide

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm Inds (in)	ZONISAMIDE	zonisamide	CAPSULE;ORAL	077634-003	Mar 17, 2006	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Azurity	ZONISADE	zonisamide	SUSPENSION;ORAL	214273-001	Jul 15, 2022		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Epic Pharma Llc	ZONISAMIDE	zonisamide	CAPSULE;ORAL	077876-001	Feb 21, 2007		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Aurobindo Pharma Ltd	ZONISAMIDE	zonisamide	CAPSULE;ORAL	077645-002	Sep 29, 2006	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Granules	ZONISAMIDE	zonisamide	CAPSULE;ORAL	077636-002	Jul 27, 2006	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for zonisamide

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

EU/EMA Drug Approvals for zonisamide

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for zonisamide

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2019038584		⤷ Try a Trial
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)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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