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Last Updated: November 27, 2022

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, Ivax Sub Teva Pharms, Mayne Pharma, 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

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Recent Clinical Trials for clozapine

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

SponsorPhase
Westfälische Wilhelms-Universität MünsterPhase 4
Dr. Inge WinterPhase 4
RenJi HospitalPhase 4

See all clozapine clinical trials

Generic filers with tentative approvals for CLOZAPINE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing25MGTABLET, ORALLY DISINTEGRATING;ORAL
See Plans and PricingSee Plans and Pricing12.5MGTABLET, ORALLY DISINTEGRATING;ORAL
See Plans and PricingSee Plans and Pricing100MGTABLET, 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
Ivax Sub Teva Pharms CLOZAPINE clozapine TABLET;ORAL 076809-001 Dec 16, 2005 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Teva Pharms Usa CLOZAPINE clozapine TABLET, ORALLY DISINTEGRATING;ORAL 203039-001 Nov 25, 2015 RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan CLOZAPINE clozapine TABLET;ORAL 075417-002 May 27, 1999 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sun Pharm Inds Inc CLOZAPINE clozapine TABLET;ORAL 075713-004 Nov 7, 2017 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Jazz FAZACLO ODT clozapine TABLET, ORALLY DISINTEGRATING;ORAL 021590-004 May 30, 2007 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Accord Hlthcare CLOZAPINE clozapine TABLET;ORAL 202873-002 Nov 25, 2015 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Jazz FAZACLO ODT clozapine TABLET, ORALLY DISINTEGRATING;ORAL 021590-002 Feb 10, 2004 See Plans and Pricing See Plans and Pricing
Jazz FAZACLO ODT clozapine TABLET, ORALLY DISINTEGRATING;ORAL 021590-003 Jun 3, 2005 See Plans and Pricing See Plans and Pricing
Jazz FAZACLO ODT clozapine TABLET, ORALLY DISINTEGRATING;ORAL 021590-004 May 30, 2007 See Plans and Pricing See Plans and Pricing
Jazz FAZACLO ODT clozapine TABLET, ORALLY DISINTEGRATING;ORAL 021590-006 Jul 9, 2010 See Plans and Pricing See Plans and Pricing
Jazz FAZACLO ODT clozapine TABLET, ORALLY DISINTEGRATING;ORAL 021590-004 May 30, 2007 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for clozapine

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

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Serving leading biopharmaceutical companies globally:

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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 verification 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.