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Last Updated: March 28, 2024

CLOZAPINE Drug Patent Profile


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Which patents cover Clozapine, and when can generic versions of Clozapine launch?

Clozapine is a drug marketed by Barr Labs Inc, Mylan, Teva Pharms Usa, Accord Hlthcare, Aurobindo Pharma, Dr Reddys Labs Sa, Ivax Sub Teva Pharms, Par Pharm, Sandoz, Sun Pharm Inds Inc, and Zydus Pharms. and is included in thirteen NDAs.

The generic ingredient in CLOZAPINE is clozapine. There are thirteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the clozapine profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Clozapine

A generic version of CLOZAPINE was approved as clozapine by IVAX SUB TEVA PHARMS on November 26th, 1997.

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Drug patent expirations by year for CLOZAPINE
Drug Prices for CLOZAPINE

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Recent Clinical Trials for CLOZAPINE

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SponsorPhase
Westfälische Wilhelms-Universität MünsterPhase 4
Dr. Inge WinterPhase 4
First Affiliated Hospital Xi'an Jiaotong UniversityN/A

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Pharmacology for CLOZAPINE
Medical Subject Heading (MeSH) Categories for CLOZAPINE
Anatomical Therapeutic Chemical (ATC) Classes for CLOZAPINE
Paragraph IV (Patent) Challenges for CLOZAPINE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
FAZACLO ODT Orally Disintegrating Tablets clozapine 200 mg 021590 1 2011-04-18
FAZACLO ODT Orally Disintegrating Tablets clozapine 150 mg 021590 1 2011-04-08
FAZACLO ODT Orally Disintegrating Tablets clozapine 12.5 mg 021590 1 2008-06-05
FAZACLO ODT Orally Disintegrating Tablets clozapine 25 mg and 100 mg 021590 1 2008-04-28

US Patents and Regulatory Information for CLOZAPINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Zydus Pharms CLOZAPINE clozapine TABLET;ORAL 209480-002 Dec 6, 2017 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Par Pharm CLOZAPINE clozapine TABLET;ORAL 075162-001 Apr 26, 2005 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan CLOZAPINE clozapine TABLET;ORAL 075417-001 May 27, 1999 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Par Pharm CLOZAPINE clozapine TABLET;ORAL 075162-002 Apr 26, 2005 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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