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Last Updated: August 9, 2020

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CLOZAPINE - Generic Drug Details

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What are the generic drug sources for clozapine and what is the scope of freedom to operate?

Clozapine is the generic ingredient in four branded drugs marketed by Tasman Pharma, Barr Labs Inc, Mylan, Teva Pharms Usa, Jazz, Accord Hlthcare, Aurobindo Pharma Ltd, Ivax Sub Teva Pharms, Mayne Pharma, Par Pharm, Sandoz, Sun Pharm Inds Inc, Zydus Pharms, and Heritage Life, and is included in sixteen NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Clozapine has six patent family members in six countries.

There are thirteen drug master file entries for clozapine. Fifteen suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for CLOZAPINE

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Recent Clinical Trials for CLOZAPINE

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

SponsorPhase
University Hospital, Strasbourg, FrancePhase 2
King's College Hospital NHS TrustEarly Phase 1
King's College LondonEarly Phase 1

See all CLOZAPINE clinical trials

Generic filers with tentative approvals for CLOZAPINE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial100MGTABLET, ORALLY DISINTEGRATING;ORAL
  Start Trial  Start Trial25MGTABLET, ORALLY DISINTEGRATING;ORAL
  Start Trial  Start Trial12.5MGTABLET, ORALLY DISINTEGRATING;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for CLOZAPINE
Medical Subject Heading (MeSH) Categories for CLOZAPINE
Paragraph IV (Patent) Challenges for CLOZAPINE
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 CLOZAPINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mayne Pharma CLOZAPINE clozapine TABLET;ORAL 203807-004 Aug 22, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Barr Labs Inc CLOZAPINE clozapine TABLET, ORALLY DISINTEGRATING;ORAL 090308-003 Apr 9, 2018 RX No No   Start Trial   Start Trial   Start Trial
Barr Labs Inc CLOZAPINE clozapine TABLET, ORALLY DISINTEGRATING;ORAL 090308-002 Nov 25, 2015 AB RX No Yes   Start Trial   Start Trial   Start Trial
Ivax Sub Teva Pharms CLOZAPINE clozapine TABLET;ORAL 074949-003 Jul 31, 2003 RX No No   Start Trial   Start Trial   Start Trial
Ivax Sub Teva Pharms CLOZAPINE clozapine TABLET;ORAL 076809-001 Dec 16, 2005 AB RX No No   Start Trial   Start Trial   Start Trial
Mayne Pharma CLOZAPINE clozapine TABLET;ORAL 203807-001 Sep 17, 2015 AB RX 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 CLOZAPINE

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

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