FAZACLO ODT Drug Patent Profile
✉ Email this page to a colleague
When do Fazaclo Odt patents expire, and what generic alternatives are available?
Fazaclo Odt is a drug marketed by Jazz and is included in one NDA.
The generic ingredient in FAZACLO ODT is clozapine. There are thirteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the clozapine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Fazaclo Odt
A generic version of FAZACLO ODT was approved as clozapine by IVAX SUB TEVA PHARMS on November 26th, 1997.
Summary for FAZACLO ODT
Recent Clinical Trials for FAZACLO ODT
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of British Columbia | Phase 4 |
Manhattan Psychiatric Center | Phase 4 |
Azur Pharma, Inc | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for FAZACLO ODT
Paragraph IV (Patent) Challenges for FAZACLO ODT
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
FAZACLO ODT | Orally Disintegrating Tablets | clozapine | 200 mg | 021590 | 1 | 2011-04-18 |
FAZACLO ODT | Orally Disintegrating Tablets | clozapine | 150 mg | 021590 | 1 | 2011-04-08 |
FAZACLO ODT | Orally Disintegrating Tablets | clozapine | 12.5 mg | 021590 | 1 | 2008-06-05 |
FAZACLO ODT | Orally Disintegrating Tablets | clozapine | 25 mg and 100 mg | 021590 | 1 | 2008-04-28 |
US Patents and Regulatory Information for FAZACLO ODT
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Jazz | FAZACLO ODT | clozapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021590-004 | May 30, 2007 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Jazz | FAZACLO ODT | clozapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021590-002 | Feb 10, 2004 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Jazz | FAZACLO ODT | clozapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021590-001 | Feb 10, 2004 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Jazz | FAZACLO ODT | clozapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021590-003 | Jun 3, 2005 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Jazz | FAZACLO ODT | clozapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021590-006 | Jul 9, 2010 | DISCN | Yes | No | ⤷ 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 FAZACLO ODT
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Jazz | FAZACLO ODT | clozapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021590-002 | Feb 10, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
Jazz | FAZACLO ODT | clozapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021590-003 | Jun 3, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
Jazz | FAZACLO ODT | clozapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021590-004 | May 30, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
Jazz | FAZACLO ODT | clozapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021590-003 | Jun 3, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
Jazz | FAZACLO ODT | clozapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021590-002 | Feb 10, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for FAZACLO ODT
See the table below for patents covering FAZACLO ODT around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 2147669 | Formule de dosage robuste à dissolution rapide (Rapidly dissolving robust dosage form) | ⤷ Try a Trial |
Denmark | 1003484 | ⤷ Try a Trial | |
Canada | 2284663 | DISSOLUTION RAPIDE DE FORME POSOLOGIQUE DE BONNE TENUE (RAPIDLY DISSOLVING ROBUST DOSAGE FORM) | ⤷ Try a Trial |
Slovenia | 20059 | Izboljšana, hitro razpadajoča, multipartikularna tableta (IMPROVED MULTIPARTICULATE TABLET WITH QUICK DISINTEGRATION) | ⤷ Try a Trial |
Denmark | 2266538 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |