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Serving leading biopharmaceutical companies globally:

Healthtrust
Mallinckrodt
AstraZeneca
Medtronic
Baxter
Chinese Patent Office
Chubb
Johnson and Johnson
Covington
Citi

Generated: November 19, 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 clozapine freedom to operate?

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, Tasman Pharma, 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.

Clozapine has forty patent family members in nineteen countries.

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

Tentative approvals for CLOZAPINE

Applicant Application No. Strength Dosage Form
u► Subscribe25MGTABLET, ORALLY DISINTEGRATING;ORAL
u► Subscribe100MGTABLET, ORALLY DISINTEGRATING;ORAL
u► Subscribe100MGTABLET, ORALLY DISINTEGRATING;ORAL
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
FAZACLO ODT
clozapine
TABLET, ORALLY DISINTEGRATING;ORAL021590-005Jul 9, 2010ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Aurobindo Pharma Ltd
CLOZAPINE
clozapine
TABLET;ORAL206433-002Nov 29, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Jazz Pharms Iii
FAZACLO ODT
clozapine
TABLET, ORALLY DISINTEGRATING;ORAL021590-005Jul 9, 2010ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Sun Pharm Inds Inc
CLOZAPINE
clozapine
TABLET;ORAL075713-002Nov 15, 2002ABRXNoNo► Subscribe► Subscribe► Subscribe
Mayne Pharma
CLOZAPINE
clozapine
TABLET;ORAL203807-004Aug 22, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Jazz Pharms Iii
FAZACLO ODT
clozapine
TABLET, ORALLY DISINTEGRATING;ORAL021590-001Feb 10, 2004ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Jazz Pharms Iii
FAZACLO ODT
clozapine
TABLET, ORALLY DISINTEGRATING;ORAL021590-001Feb 10, 2004ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Jazz Pharms Iii
FAZACLO ODT
clozapine
TABLET, ORALLY DISINTEGRATING;ORAL021590-004May 30, 2007RXYesNo► Subscribe► SubscribeY ► Subscribe
Mylan Pharms Inc
CLOZAPINE
clozapine
TABLET, ORALLY DISINTEGRATING;ORAL201824-002Sep 15, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Teva Pharms Usa
CLOZAPINE
clozapine
TABLET, ORALLY DISINTEGRATING;ORAL203039-001Nov 25, 2015ABRXNoNo► Subscribe► Subscribe► 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;ORAL021590-003Jun 3, 2005► Subscribe► Subscribe
Jazz Pharms Iii
FAZACLO ODT
clozapine
TABLET, ORALLY DISINTEGRATING;ORAL021590-004May 30, 2007► Subscribe► Subscribe
Jazz Pharms Iii
FAZACLO ODT
clozapine
TABLET, ORALLY DISINTEGRATING;ORAL021590-001Feb 10, 2004► Subscribe► Subscribe
Jazz Pharms Iii
FAZACLO ODT
clozapine
TABLET, ORALLY DISINTEGRATING;ORAL021590-002Feb 10, 2004► Subscribe► Subscribe
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International Patent Family for Ingredient: clozapine

Country Document Number Estimated Expiration
New Zealand502228► Subscribe
Portugal2147669► Subscribe
Portugal1003484► Subscribe
European Patent Office2266538► Subscribe
France2766089► Subscribe
Spain2167921► Subscribe
Japan2008001726► Subscribe
Australia4930197► Subscribe
Japan2012162558► Subscribe
Brazil9811803► 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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Serving leading biopharmaceutical companies globally:

Deloitte
Chubb
McKinsey
Cipla
Cantor Fitzgerald
Citi
Argus Health
Dow
Harvard Business School
Teva

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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