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Generated: April 23, 2017

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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?

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

Clozapine has thirty-five patent family members in nineteen countries.

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

Summary for Generic Name: clozapine

Drug Master File Entries: see list12
Suppliers / Packagers: see list16
Bulk Api Vendors: see list76
Clinical Trials: see list41
Patent Applications: see list6,007
Therapeutic Class:Antipsychotics
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:clozapine at DailyMed

Pharmacology for Ingredient: clozapine

Tentative approvals for CLOZAPINE

Applicant Application No. Form Dosage
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Jazz Pharms Iii
TABLET, ORALLY DISINTEGRATING;ORAL021590-003Jun 3, 2005DISCNNoNo6,221,392► SubscribeY ► Subscribe
Ivax Sub Teva Pharms
TABLET;ORAL074949-001Nov 26, 1997ABRXNoNo► Subscribe► Subscribe
Jazz Pharms Iii
TABLET, ORALLY DISINTEGRATING;ORAL021590-002Feb 10, 2004ABRXYesYes6,221,392► SubscribeY ► Subscribe
Sun Pharm Inds Inc
TABLET;ORAL075713-003Aug 19, 2005ABRXNoNo► Subscribe► Subscribe
TABLET;ORAL075417-002May 27, 1999ABRXNoNo► Subscribe► Subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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