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Last Updated: September 25, 2022

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. 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.

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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

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SponsorPhase
University of British ColumbiaPhase 4
Manhattan Psychiatric CenterPhase 4
Azur Pharma, IncPhase 4

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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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Jazz FAZACLO ODT clozapine TABLET, ORALLY DISINTEGRATING;ORAL 021590-002 Feb 10, 2004 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Jazz FAZACLO ODT clozapine TABLET, ORALLY DISINTEGRATING;ORAL 021590-001 Feb 10, 2004 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 021590-003 Jun 3, 2005 See Plans and Pricing See Plans and Pricing
Jazz FAZACLO ODT clozapine TABLET, ORALLY DISINTEGRATING;ORAL 021590-005 Jul 9, 2010 See Plans and Pricing See Plans and Pricing
Jazz FAZACLO ODT clozapine TABLET, ORALLY DISINTEGRATING;ORAL 021590-003 Jun 3, 2005 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

McKesson
Baxter
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McKinsey
Express Scripts
Johnson and Johnson

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