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.
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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: | 4,170 |
| 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 |
|---|---|
| The University of Akron | Phase 2 |
| Washington University School of Medicine | Phase 2 |
| Gateway Biotechnology, Inc. | 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 |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Concordia | ZONEGRAN | zonisamide | CAPSULE;ORAL | 020789-002 | Aug 22, 2003 | DISCN | Yes | 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 | |||
| >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 | ⤷ Sign Up | ⤷ Sign Up |
| >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 |
|---|---|---|---|
| Portugal | 1040830 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 9933465 | ⤷ Sign Up | |
| China | 1149084 | ⤷ Sign Up | |
| South Korea | 20010015890 | ⤷ Sign Up | |
| Hong Kong | 1029043 | ⤷ Sign Up | |
| European Patent Office | 1040830 | REMEDE POUR MALADIES NEURODEGENERATIVES (REMEDY FOR NEURODEGENERATIVE DISEASES) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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