Is there a generic for Zonisamide?

Yes. The FDA Orange Book lists 19 approved generic (ANDA) applications for Zonisamide, referencing the brand ZONISADE. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Zonisamide?

ZONISADE (NDA 214273, AZURITY) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Zonisamide?

The Orange Book lists 3 patents against Zonisamide products, with the earliest listed expiry in 2038. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Zonisamide are approved?

Zonisamide is approved in the following dosage forms: capsule, suspension.

FDA Orange Book · active-ingredient family

Zonisamide

Zonisamide is approved as 2 brand and 19 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ZONISADE · NDA 214273

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · capsule, suspension

Product	Applicant	Application	TE	Approved
ZONISADERLD	AZURITY	NDA 214273	—	Jul 15, 2022
ZONEGRANRLD×3	ADVANZ PHARMA	NDA 020789	AB	Aug 22, 2003

Generic (ANDA) products (19)

Product	Applicant	Application	TE	Approved
ZONISAMIDE×3	MACLEODS PHARMS LTD	ANDA 219507	—	May 12, 2025
ZONISAMIDE×3	UNICHEM	ANDA 214492	AB	Jan 26, 2021
ZONISAMIDE×3	EPIC PHARMA LLC	ANDA 077876	—	Feb 21, 2007
ZONISAMIDE×3	ZYDUS LIFESCIENCES	ANDA 077625	AB	Oct 16, 2006
ZONISAMIDE×3	AUROBINDO PHARMA LTD	ANDA 077645	AB	Sep 29, 2006
ZONISAMIDE×3	BIONPHARMA	ANDA 077813	AB	Aug 16, 2006
ZONISAMIDE×3	GRANULES	ANDA 077636	AB	Jul 27, 2006
ZONISAMIDE×3	INVAGEN PHARMS	ANDA 077869	AB	May 31, 2006
ZONISAMIDE×3	CHARTWELL RX	ANDA 077650	—	Apr 20, 2006
ZONISAMIDE×3	SUN PHARM INDS (IN)	ANDA 077634	—	Mar 17, 2006
ZONISAMIDE×3	GLENMARK PHARMS	ANDA 077651	AB	Jan 30, 2006
ZONISAMIDE×3	ANI PHARMS	ANDA 077639	—	Dec 22, 2005
ZONISAMIDE×3	ANI PHARMS	ANDA 077641	—	Dec 22, 2005
ZONISAMIDE×3	APOTEX	ANDA 077642	—	Dec 22, 2005
ZONISAMIDE×3	PHARMOBEDIENT	ANDA 077647	—	Dec 22, 2005
ZONISAMIDE×3	RISING	ANDA 077637	—	Dec 22, 2005
ZONISAMIDE×3	ROXANE	ANDA 077648	—	Dec 22, 2005
ZONISAMIDE×3	SUN PHARM INDUSTRIES	ANDA 077635	—	Dec 22, 2005
ZONISAMIDE×3	UPSHER SMITH LABS	ANDA 077644	—	Dec 22, 2005

Listed patents (3)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
11478456	Aug 18, 2038	in 12 yr 4 mo	U-3458
12491179	Aug 18, 2038	in 12 yr 4 mo	Product
11529333	Aug 18, 2038	in 12 yr 4 mo	Product

Zonisamide — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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