Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 20, 2019

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FAZACLO ODT Drug Profile

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When do Fazaclo Odt patents expire, 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. Sixteen suppliers are listed for this compound. Additional details are available on the clozapine profile page.

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

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Recent Litigation for FAZACLO ODT

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District Court Litigation
Case NameDate
Purdue Pharmaceutical v. Actavis Elizabeth LLC2015-05-13
CIMA Labs Inc. v. Barr Laboratories Inc.2008-08-21
Cephalon Inc. v. Barr Pharmaceuticals Inc.2008-07-22

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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 AB RX Yes No   Start Trial   Start Trial   Start Trial
Jazz FAZACLO ODT clozapine TABLET, ORALLY DISINTEGRATING;ORAL 021590-002 Feb 10, 2004 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Jazz FAZACLO ODT clozapine TABLET, ORALLY DISINTEGRATING;ORAL 021590-001 Feb 10, 2004 AB RX 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 021590-002 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 021590-004 May 30, 2007   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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