.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

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

DrugPatentWatch Database Preview

Clozapine - Generic Drug Details

« Back to Dashboard
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, Teva Pharms Usa, Sandoz, Heritage Life, Par Pharm, Accord Hlthcare, and Jazz Pharms Iii, and is included in fourteen 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. Fourteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: clozapine

Tradenames:4
Patents:3
Applicants:12
NDAs:14
Drug Master File Entries: see list12
Suppliers / Packaging: see list14
Therapeutic Class:Antipsychotics
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: clozapine

Tentative approvals for CLOZAPINE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET, ORALLY DISINTEGRATING;ORAL12.5MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Pharms Usa
CLOZAPINE
clozapine
TABLET, ORALLY DISINTEGRATING;ORAL203039-002Nov 25, 2015RXNo► subscribe► subscribe
Mylan Pharms Inc
CLOZAPINE
clozapine
TABLET, ORALLY DISINTEGRATING;ORAL201824-003Sep 15, 2015RXNo► subscribe► subscribe
Jazz Pharms Iii
FAZACLO ODT
clozapine
TABLET, ORALLY DISINTEGRATING;ORAL021590-004May 30, 2007RXNo6,221,392► subscribeY ► 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

These historical archives are available as an add-on to one-year subscriptions.
See the Subscription Options for more information.

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;ORAL021590-004May 30, 20075,178,878► subscribe
Jazz Pharms Iii
FAZACLO ODT
clozapine
TABLET, ORALLY DISINTEGRATING;ORAL021590-003Jun 3, 20055,178,878► 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
Portugal2147669► subscribe
Japan2012162558► subscribe
Austria208616► 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

How are People Using DrugPatentWatch?

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.

`abc