ZONEGRAN Drug Patent Profile
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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 22nd, 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 |
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 |
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
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Concordia | ZONEGRAN | zonisamide | CAPSULE;ORAL | 020789-002 | Aug 22, 2003 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Concordia | ZONEGRAN | zonisamide | CAPSULE;ORAL | 020789-001 | Mar 27, 2000 | AB | RX | Yes | Yes | ⤷ 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 ZONEGRAN
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 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 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
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 | ⤷ Try a Trial | |
Hong Kong | 1029043 | ⤷ Try a Trial | |
China | 1283113 | ⤷ Try a Trial | |
China | 1149084 | ⤷ Try a Trial | |
Germany | 69830512 | ⤷ Try a Trial | |
Japan | 3364481 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |