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Last Updated: August 9, 2020

DrugPatentWatch Database Preview

FAZACLO ODT Drug Profile

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Which patents cover Fazaclo Odt, and when can generic versions of Fazaclo Odt launch?

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.

US ANDA 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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Drug patent expirations by year for FAZACLO ODT
Drug Prices for FAZACLO ODT

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Recent Clinical Trials for FAZACLO ODT

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Azur Pharma, IncPhase 4
Manhattan Psychiatric CenterPhase 4
Azur Pharma, IncN/A

See all FAZACLO ODT clinical trials

Pharmacology for FAZACLO ODT
Paragraph IV (Patent) Challenges for FAZACLO ODT
Tradename Dosage Ingredient NDA Submissiondate
FAZACLO ODT TABLET, ORALLY DISINTEGRATING;ORAL clozapine 021590 2011-04-18
FAZACLO ODT TABLET, ORALLY DISINTEGRATING;ORAL clozapine 021590 2011-04-08
FAZACLO ODT TABLET, ORALLY DISINTEGRATING;ORAL clozapine 021590 2008-06-05
FAZACLO ODT TABLET, ORALLY DISINTEGRATING;ORAL clozapine 021590 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   Start Trial   Start Trial   Start Trial
Jazz FAZACLO ODT clozapine TABLET, ORALLY DISINTEGRATING;ORAL 021590-002 Feb 10, 2004 DISCN Yes No   Start Trial   Start Trial   Start Trial
Jazz FAZACLO ODT clozapine TABLET, ORALLY DISINTEGRATING;ORAL 021590-001 Feb 10, 2004 DISCN Yes No   Start Trial   Start Trial   Start Trial
Jazz FAZACLO ODT clozapine TABLET, ORALLY DISINTEGRATING;ORAL 021590-003 Jun 3, 2005 DISCN No No   Start Trial   Start Trial   Start 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   Start Trial   Start Trial
Jazz FAZACLO ODT clozapine TABLET, ORALLY DISINTEGRATING;ORAL 021590-003 Jun 3, 2005   Start Trial   Start Trial
Jazz FAZACLO ODT clozapine TABLET, ORALLY DISINTEGRATING;ORAL 021590-001 Feb 10, 2004   Start Trial   Start Trial
Jazz FAZACLO ODT clozapine TABLET, ORALLY DISINTEGRATING;ORAL 021590-006 Jul 9, 2010   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

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