ZONISAMIDE Drug Patent Profile
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Which patents cover Zonisamide, and what generic alternatives are available?
Zonisamide is a drug marketed by 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, and Zydus Lifesciences. and is included in eighteen NDAs.
The generic ingredient in ZONISAMIDE 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 Zonisamide
A generic version of ZONISAMIDE was approved as zonisamide by APOTEX INC on December 22nd, 2005.
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Questions you can ask:
- What is the 5 year forecast for ZONISAMIDE?
- What are the global sales for ZONISAMIDE?
- What is Average Wholesale Price for ZONISAMIDE?
Summary for ZONISAMIDE
| US Patents: | 0 |
| Applicants: | 17 |
| NDAs: | 18 |
| Finished Product Suppliers / Packagers: | 18 |
| Raw Ingredient (Bulk) Api Vendors: | 122 |
| Clinical Trials: | 68 |
| Patent Applications: | 5,106 |
| Drug Prices: | Drug price information for ZONISAMIDE |
| Drug Sales Revenues: | Drug sales revenues for ZONISAMIDE |
| DailyMed Link: | ZONISAMIDE at DailyMed |
See drug prices for ZONISAMIDE
Recent Clinical Trials for ZONISAMIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Washington State University | Phase 2 |
| Gateway Biotechnology, Inc. | Phase 2 |
| University of Texas | Phase 2 |
Pharmacology for ZONISAMIDE
| 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 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sun Pharm Inds (in) | ZONISAMIDE | zonisamide | CAPSULE;ORAL | 077634-002 | Mar 17, 2006 | AB | RX | 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 | ||||
| Upsher Smith Labs | ZONISAMIDE | zonisamide | CAPSULE;ORAL | 077644-001 | Dec 22, 2005 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sun Pharm Industries | ZONISAMIDE | zonisamide | CAPSULE;ORAL | 077635-003 | Dec 22, 2005 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Upsher Smith Labs | ZONISAMIDE | zonisamide | CAPSULE;ORAL | 077644-002 | Dec 22, 2005 | 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 |
