FAZACLO ODT Drug Patent Profile
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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. Twelve 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.
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Summary for FAZACLO ODT
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 132 |
| Clinical Trials: | 3 |
| Patent Applications: | 5,220 |
| Drug Prices: | Drug price information for FAZACLO ODT |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for FAZACLO ODT |
| DailyMed Link: | FAZACLO ODT at DailyMed |
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 |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Jazz | FAZACLO ODT | clozapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021590-002 | Feb 10, 2004 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Jazz | FAZACLO ODT | clozapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021590-001 | Feb 10, 2004 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Jazz | FAZACLO ODT | clozapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021590-003 | Jun 3, 2005 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Jazz | FAZACLO ODT | clozapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021590-006 | Jul 9, 2010 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Jazz | FAZACLO ODT | clozapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021590-005 | Jul 9, 2010 | DISCN | Yes | 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 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 | ⤷ Sign Up | ⤷ Sign Up |
| Jazz | FAZACLO ODT | clozapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021590-002 | Feb 10, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Jazz | FAZACLO ODT | clozapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021590-003 | Jun 3, 2005 | ⤷ Sign Up | ⤷ Sign Up |
| Jazz | FAZACLO ODT | clozapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021590-004 | May 30, 2007 | ⤷ Sign Up | ⤷ Sign Up |
| Jazz | FAZACLO ODT | clozapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021590-006 | Jul 9, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| Jazz | FAZACLO ODT | clozapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021590-004 | May 30, 2007 | ⤷ Sign Up | ⤷ Sign Up |
| Jazz | FAZACLO ODT | clozapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021590-001 | Feb 10, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| >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 |
|---|---|---|---|
| Australia | 8865998 | ⤷ Sign Up | |
| Australia | 708197 | ⤷ Sign Up | |
| European Patent Office | 0896818 | ⤷ Sign Up | |
| European Patent Office | 0494972 | PRESENTATION SOUS FORME EFFERVESCENTE D'UN MEDICAMENT A USAGE PEDIATRIQUE (EFFERVESCENT DOSAGE FORM AND METHOD OF ADMINISTERING SAME) | ⤷ Sign Up |
| China | 1309374 | ⤷ Sign Up | |
| Japan | 3190299 | ⤷ Sign Up | |
| Brazil | 9811803 | ⤷ 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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