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Last Updated: October 12, 2024

Zonisamide - Generic Drug Details


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What are the generic sources for zonisamide and what is the scope of patent protection?

Zonisamide is the generic ingredient in three branded drugs marketed by Concordia, Ani Pharms, Apotex Inc, Aurobindo Pharma Ltd, Bionpharma, Epic Pharma Llc, Glenmark Pharms Inc, Granules, Heritage Pharma Avet, Invagen Pharms, Norvium Bioscience, 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.

Drug Prices for zonisamide

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Drug Sales Revenue Trends for zonisamide

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Recent Clinical Trials for zonisamide

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Washington State UniversityPhase 2
Washington University School of MedicinePhase 2
Gateway Biotechnology, Inc.Phase 2

See all zonisamide clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for zonisamide

US Patents and Regulatory Information for zonisamide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Epic Pharma Llc ZONISAMIDE zonisamide CAPSULE;ORAL 077876-001 Feb 21, 2007 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Norvium Bioscience ZONISAMIDE zonisamide CAPSULE;ORAL 077647-002 Dec 22, 2005 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Concordia ZONEGRAN zonisamide CAPSULE;ORAL 020789-001 Mar 27, 2000 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aurobindo Pharma Ltd ZONISAMIDE zonisamide CAPSULE;ORAL 077645-003 Sep 29, 2006 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Epic Pharma Llc ZONISAMIDE zonisamide CAPSULE;ORAL 077876-002 Feb 21, 2007 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for zonisamide

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

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2019038584 ⤷  Sign Up
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) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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