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Last Updated: March 29, 2024

Clozapine - Generic Drug Details


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What are the generic drug sources for clozapine and what is the scope of patent protection?

Clozapine is the generic ingredient in four branded drugs marketed by Tasman Pharma, Barr Labs Inc, Mylan, Teva Pharms Usa, Jazz, Accord Hlthcare, Aurobindo Pharma, Dr Reddys Labs Sa, Ivax Sub Teva Pharms, Par Pharm, Sandoz, Sun Pharm Inds Inc, Zydus Pharms, and Heritage Life, and is included in sixteen NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Clozapine has six patent family members in six countries.

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

Drug Prices for clozapine

See drug prices for clozapine

Recent Clinical Trials for clozapine

Identify potential brand extensions & 505(b)(2) entrants

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

See all clozapine clinical trials

Generic filers with tentative approvals for CLOZAPINE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial200MGTABLET, ORALLY DISINTEGRATING;ORAL
⤷  Try a Trial⤷  Try a Trial150MGTABLET, ORALLY DISINTEGRATING;ORAL
⤷  Try a Trial⤷  Try a Trial100MGTABLET, ORALLY DISINTEGRATING;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for clozapine
Medical Subject Heading (MeSH) Categories 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
Jazz FAZACLO ODT clozapine TABLET, ORALLY DISINTEGRATING;ORAL 021590-002 Feb 10, 2004 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ivax Sub Teva Pharms CLOZAPINE clozapine TABLET;ORAL 076809-001 Dec 16, 2005 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurobindo Pharma CLOZAPINE clozapine TABLET;ORAL 206433-001 Nov 29, 2016 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ivax Sub Teva Pharms CLOZAPINE clozapine TABLET;ORAL 074949-003 Jul 31, 2003 RX 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

Expired US Patents for clozapine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Jazz FAZACLO ODT clozapine TABLET, ORALLY DISINTEGRATING;ORAL 021590-002 Feb 10, 2004 ⤷  Try a Trial ⤷  Try a Trial
Jazz FAZACLO ODT clozapine TABLET, ORALLY DISINTEGRATING;ORAL 021590-003 Jun 3, 2005 ⤷  Try a Trial ⤷  Try a Trial
Jazz FAZACLO ODT clozapine TABLET, ORALLY DISINTEGRATING;ORAL 021590-004 May 30, 2007 ⤷  Try a Trial ⤷  Try a Trial
Jazz FAZACLO ODT clozapine TABLET, ORALLY DISINTEGRATING;ORAL 021590-003 Jun 3, 2005 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for clozapine

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2005007168 ⤷  Try a Trial
Spain 2436213 ⤷  Try a Trial
Australia 2004257556 A stable clozapine suspension formulation ⤷  Try a Trial
European Patent Office 1646393 FORMULATION DE SUSPENSION STABLE DE CLOZAPINE (A STABLE CLOZAPINE SUSPENSION FORMULATION) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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