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.
Summary for zonisamide
International Patents: | 2 |
US Patents: | 2 |
Tradenames: | 3 |
Applicants: | 19 |
NDAs: | 20 |
Drug Master File Entries: | 19 |
Finished Product Suppliers / Packagers: | 20 |
Raw Ingredient (Bulk) Api Vendors: | 122 |
Clinical Trials: | 68 |
Patent Applications: | 6,641 |
Drug Prices: | Drug price trends for zonisamide |
Drug Sales Revenues: | Drug sales revenues for zonisamide |
What excipients (inactive ingredients) are in zonisamide? | zonisamide excipients list |
DailyMed Link: | zonisamide at DailyMed |
Recent Clinical Trials for zonisamide
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Washington State University | Phase 2 |
Washington University School of Medicine | Phase 2 |
Gateway Biotechnology, Inc. | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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 |
Expired US Patents for zonisamide
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 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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