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Clozapine - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for clozapine?

Clozapine 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 three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has thirty-five patent family members in nineteen countries.

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

Summary for Generic Name: clozapine

Tradenames:4
Patents:4
Applicants:13
NDAs:15
Drug Master File Entries: see list12
Suppliers / Packagers: see list15
Bulk Api Vendors: see list76
Clinical Trials: see list41
Patent Applications: see list5,986
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
► Subscribe► SubscribeTABLET, ORALLY DISINTEGRATING;ORAL12.5MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Jazz Pharms Iii
FAZACLO ODT
clozapine
TABLET, ORALLY DISINTEGRATING;ORAL021590-003Jun 3, 2005DISCNNoNo6,024,981► SubscribeY ► Subscribe
Aurobindo Pharma Ltd
CLOZAPINE
clozapine
TABLET;ORAL206433-004Nov 29, 2016RXNoNo► Subscribe► Subscribe
Jazz Pharms Iii
FAZACLO ODT
clozapine
TABLET, ORALLY DISINTEGRATING;ORAL021590-002Feb 10, 2004RXYesYes6,106,861► SubscribeY ► Subscribe
Mylan Pharms Inc
CLOZAPINE
clozapine
TABLET, ORALLY DISINTEGRATING;ORAL201824-003Sep 15, 2015RXNoNo► Subscribe► Subscribe
Jazz Pharms Iii
FAZACLO ODT
clozapine
TABLET, ORALLY DISINTEGRATING;ORAL021590-001Feb 10, 2004RXYesNo6,106,861► SubscribeY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: clozapine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Jazz Pharms Iii
FAZACLO ODT
clozapine
TABLET, ORALLY DISINTEGRATING;ORAL021590-001Feb 10, 20045,178,878► Subscribe
Jazz Pharms Iii
FAZACLO ODT
clozapine
TABLET, ORALLY DISINTEGRATING;ORAL021590-003Jun 3, 20055,178,878► Subscribe
Jazz Pharms Iii
FAZACLO ODT
clozapine
TABLET, ORALLY DISINTEGRATING;ORAL021590-002Feb 10, 20045,178,878► Subscribe
Jazz Pharms Iii
FAZACLO ODT
clozapine
TABLET, ORALLY DISINTEGRATING;ORAL021590-004May 30, 20075,178,878► Subscribe
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International Patent Family for Ingredient: clozapine

Country Document Number Estimated Expiration
Israel130339► Subscribe
Austria208616► Subscribe
JapanH1135450► Subscribe
Japan2012162558► Subscribe
Denmark1003484► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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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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