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Generated: September 24, 2019

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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 clozapine 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. Additional information is available in the individual branded drug profile pages.

There are thirteen drug master file entries for clozapine. Sixteen suppliers are listed for this compound. There are two tentative approvals for this compound.

Pharmacology for clozapine
Medical Subject Heading (MeSH) Categories for clozapine
Generic filers with tentative approvals for CLOZAPINE
Applicant Application No. Strength Dosage Form
  Try a Free Trial  Try a Free Trial100MGTABLET, ORALLY DISINTEGRATING;ORAL
  Try a Free Trial  Try a Free Trial25MGTABLET, ORALLY DISINTEGRATING;ORAL
  Try a Free Trial  Try a Free Trial100MGTABLET, 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.

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
Mylan CLOZAPINE clozapine TABLET;ORAL 075417-005 Apr 15, 2010 AB RX No No   Try a Free Trial   Try a Free Trial   Try a Free Trial
Jazz FAZACLO ODT clozapine TABLET, ORALLY DISINTEGRATING;ORAL 021590-001 Feb 10, 2004 AB RX Yes No   Try a Free Trial   Try a Free Trial   Try a Free Trial
Mayne Pharma CLOZAPINE clozapine TABLET;ORAL 203807-004 Aug 22, 2017 AB RX No No   Try a Free Trial   Try a Free Trial   Try a Free 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 021590-006 Jul 9, 2010   Try a Free Trial   Try a Free Trial
Jazz FAZACLO ODT clozapine TABLET, ORALLY DISINTEGRATING;ORAL 021590-002 Feb 10, 2004   Try a Free Trial   Try a Free Trial
Jazz FAZACLO ODT clozapine TABLET, ORALLY DISINTEGRATING;ORAL 021590-004 May 30, 2007   Try a Free Trial   Try a Free Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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