.

Deeper Knowledge, Faster

  • Identify first generic entrants
  • Obtain formulation and manufacturing information
  • Drug patents in 130+ countries

► See Plans & Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
Novartis
Accenture
Citi
Fish and Richardson
Deloitte
Covington
McKesson
Cantor Fitzgerald
US Army

Generated: September 26, 2017

DrugPatentWatch Database Preview

Clozapine - Generic Drug Details

« Back to Dashboard

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, 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 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 are two tentative approvals for this compound.

Summary for Generic Name: clozapine

Tradenames:4
Patents:3
Applicants:13
NDAs:15
Drug Master File Entries: see list12
Suppliers / Packagers: see list16
Bulk Api Vendors: see list76
Clinical Trials: see list149
Patent Applications: see list5,638
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. Strength Dosage Form
► Subscribe► Subscribe25MGTABLET, ORALLY DISINTEGRATING;ORAL
► Subscribe► Subscribe100MGTABLET, ORALLY DISINTEGRATING;ORAL
► Subscribe► 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
Barr Labs Inc
CLOZAPINE
clozapine
TABLET, ORALLY DISINTEGRATING;ORAL090308-002Nov 25, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Jazz Pharms Iii
FAZACLO ODT
clozapine
TABLET, ORALLY DISINTEGRATING;ORAL021590-004May 30, 2007RXYesNo► Subscribe► SubscribeY ► Subscribe
Jazz Pharms Iii
FAZACLO ODT
clozapine
TABLET, ORALLY DISINTEGRATING;ORAL021590-003Jun 3, 2005DISCNNoNo► Subscribe► SubscribeY ► Subscribe
Jazz Pharms Iii
FAZACLO ODT
clozapine
TABLET, ORALLY DISINTEGRATING;ORAL021590-005Jul 9, 2010ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Jazz Pharms Iii
FAZACLO ODT
clozapine
TABLET, ORALLY DISINTEGRATING;ORAL021590-002Feb 10, 2004ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Mylan
CLOZAPINE
clozapine
TABLET;ORAL075417-005Apr 15, 2010ABRXNoNo► Subscribe► Subscribe► Subscribe
Jazz Pharms Iii
FAZACLO ODT
clozapine
TABLET, ORALLY DISINTEGRATING;ORAL021590-001Feb 10, 2004ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Sun Pharm Inds Inc
CLOZAPINE
clozapine
TABLET;ORAL075713-002Nov 15, 2002ABRXNoNo► Subscribe► Subscribe► Subscribe
Ivax Sub Teva Pharms
CLOZAPINE
clozapine
TABLET;ORAL074949-001Nov 26, 1997ABRXNoNo► Subscribe► Subscribe► Subscribe
Jazz Pharms Iii
VERSACLOZ
clozapine
SUSPENSION;ORAL203479-001Feb 6, 2013RXYesYes► Subscribe► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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;ORAL021590-004May 30, 2007► Subscribe► Subscribe
Jazz Pharms Iii
FAZACLO ODT
clozapine
TABLET, ORALLY DISINTEGRATING;ORAL021590-003Jun 3, 2005► Subscribe► Subscribe
Jazz Pharms Iii
FAZACLO ODT
clozapine
TABLET, ORALLY DISINTEGRATING;ORAL021590-001Feb 10, 2004► Subscribe► Subscribe
Jazz Pharms Iii
FAZACLO ODT
clozapine
TABLET, ORALLY DISINTEGRATING;ORAL021590-002Feb 10, 2004► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Ingredient: clozapine

Country Document Number Estimated Expiration
European Patent Office0975336► Subscribe
France2766089► Subscribe
Israel130339► Subscribe
Turkey200000139► Subscribe
JapanH1135450► Subscribe
Japan2012162558► Subscribe
China1309374► Subscribe
Denmark2147669► Subscribe
World Intellectual Property Organization (WIPO)9846215► Subscribe
Australia6896998► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Medtronic
Argus Health
Merck
McKinsey
Chinese Patent Office
Mallinckrodt
Queensland Health
Cerilliant
Daiichi Sankyo
McKesson

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted Heap | Mobile and Web Analytics
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot