ZONEGRAN Drug Patent Profile

Which patents cover Zonegran, and when can generic versions of Zonegran launch?

Zonegran is a drug marketed by Concordia and is included in one NDA.

The generic ingredient in ZONEGRAN is zonisamide. There are nineteen drug master file entries for this compound. Twenty 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:	5,091
Formulation / Manufacturing:	see details
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
Washington University School of Medicine	Phase 2
Gateway Biotechnology, Inc.	Phase 2
University of Texas	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

Anatomical Therapeutic Chemical (ATC) Classes for ZONEGRAN

N03AX	Other antiepileptics
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

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
Concordia	ZONEGRAN	zonisamide	CAPSULE;ORAL	020789-003	Aug 22, 2003	AB	RX	Yes	No
Concordia	ZONEGRAN	zonisamide	CAPSULE;ORAL	020789-002	Aug 22, 2003		DISCN	Yes	No
Concordia	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
Concordia	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
World Intellectual Property Organization (WIPO)	9933465
Hong Kong	1029043
China	1283113