Clozapine - Generic Drug Details

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What are the generic drug sources for clozapine and what is the scope of freedom to operate?

Clozapine is the generic ingredient in four branded drugs marketed by Tasman Pharma, Barr Labs Inc, Mylan, 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 fifteen 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. Twelve suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for clozapine

International Patents:	6
US Patents:	1
Tradenames:	4
Applicants:	13
NDAs:	15
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	133
Clinical Trials:	183
Drug Prices:	Drug price trends for clozapine
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for clozapine
What excipients (inactive ingredients) are in clozapine?	clozapine excipients list
DailyMed Link:	clozapine at DailyMed

See drug prices for clozapine

Recent Clinical Trials for clozapine

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

Sponsor	Phase
Intra-Cellular Therapies, Inc.	Phase 4
Westfälische Wilhelms-Universität Münster	Phase 4
Dr. Inge Winter	Phase 4

See all clozapine clinical trials

Generic filers with tentative approvals for CLOZAPINE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	200MG	TABLET, ORALLY DISINTEGRATING;ORAL
⤷ Sign Up	⤷ Sign Up	150MG	TABLET, ORALLY DISINTEGRATING;ORAL
⤷ Sign Up	⤷ Sign Up	100MG	TABLET, 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

Drug Class	Atypical Antipsychotic

Medical Subject Heading (MeSH) Categories for clozapine

Antipsychotic Agents
GABA Antagonists
Serotonin Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for clozapine

N05AH	Diazepines, oxazepines, thiazepines and oxepines
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan	CLOZAPINE	clozapine	TABLET, ORALLY DISINTEGRATING;ORAL	201824-005	Aug 7, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm Inds Inc	CLOZAPINE	clozapine	TABLET;ORAL	075713-001	Nov 15, 2002	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sandoz	CLOZAPINE	clozapine	TABLET;ORAL	074546-002	Aug 30, 1996		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Heritage Life	CLOZARIL	clozapine	TABLET;ORAL	019758-004	May 20, 2019		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan	CLOZAPINE	clozapine	TABLET, ORALLY DISINTEGRATING;ORAL	201824-004	Aug 7, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zydus Pharms	CLOZAPINE	clozapine	TABLET;ORAL	209480-002	Dec 6, 2017		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

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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	⤷ Sign Up	⤷ Sign Up
Jazz	FAZACLO ODT	clozapine	TABLET, ORALLY DISINTEGRATING;ORAL	021590-002	Feb 10, 2004	⤷ Sign Up	⤷ Sign Up
Jazz	FAZACLO ODT	clozapine	TABLET, ORALLY DISINTEGRATING;ORAL	021590-003	Jun 3, 2005	⤷ Sign Up	⤷ Sign Up
Jazz	FAZACLO ODT	clozapine	TABLET, ORALLY DISINTEGRATING;ORAL	021590-004	May 30, 2007	⤷ Sign Up	⤷ Sign Up
Jazz	FAZACLO ODT	clozapine	TABLET, ORALLY DISINTEGRATING;ORAL	021590-006	Jul 9, 2010	⤷ Sign Up	⤷ Sign Up
Jazz	FAZACLO ODT	clozapine	TABLET, ORALLY DISINTEGRATING;ORAL	021590-004	May 30, 2007	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for clozapine

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Country	Patent Number	Title	Estimated Expiration
New Zealand	527142	A stable suspension formulation	⤷ Sign Up
Spain	2436213		⤷ Sign Up
European Patent Office	1646393	FORMULATION DE SUSPENSION STABLE DE CLOZAPINE (A STABLE CLOZAPINE SUSPENSION FORMULATION)	⤷ Sign Up
Canada	2532648	FORMULATION DE SUSPENSION STABLE DE CLOZAPINE (A STABLE CLOZAPINE SUSPENSION FORMULATION)	⤷ Sign Up
Australia	2004257556	A stable clozapine suspension formulation	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2005007168		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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