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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, Teva Pharms Usa, Jazz, Accord Hlthcare, Aurobindo Pharma Ltd, 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.
Summary for clozapine
| International Patents: | 6 |
| US Patents: | 1 |
| Tradenames: | 4 |
| Applicants: | 14 |
| NDAs: | 16 |
| Drug Master File Entries: | 13 |
| Suppliers / Packagers: | 15 |
| Bulk Api Vendors: | 101 |
| Clinical Trials: | 162 |
| Patent Applications: | 5,915 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for clozapine |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for clozapine |
| DailyMed Link: | clozapine at DailyMed |
Recent Clinical Trials for clozapine
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University Hospital, Strasbourg, France | Phase 2 |
| King's College Hospital NHS Trust | Early Phase 1 |
| King's College London | Early Phase 1 |
Generic filers with tentative approvals for CLOZAPINE
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | 100MG | TABLET, ORALLY DISINTEGRATING;ORAL |
| Start Trial | Start Trial | 25MG | TABLET, ORALLY DISINTEGRATING;ORAL |
| Start Trial | Start Trial | 12.5MG | 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
Paragraph IV (Patent) Challenges for CLOZAPINE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| FAZACLO ODT | TABLET, ORALLY DISINTEGRATING;ORAL | clozapine | 021590 | 2011-04-18 |
| FAZACLO ODT | TABLET, ORALLY DISINTEGRATING;ORAL | clozapine | 021590 | 2011-04-08 |
| FAZACLO ODT | TABLET, ORALLY DISINTEGRATING;ORAL | clozapine | 021590 | 2008-06-05 |
| FAZACLO ODT | TABLET, ORALLY DISINTEGRATING;ORAL | clozapine | 021590 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mayne Pharma | CLOZAPINE | clozapine | TABLET;ORAL | 203807-004 | Aug 22, 2017 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Barr Labs Inc | CLOZAPINE | clozapine | TABLET, ORALLY DISINTEGRATING;ORAL | 090308-003 | Apr 9, 2018 | RX | No | No | Start Trial | Start Trial | Start Trial | ||||
| Barr Labs Inc | CLOZAPINE | clozapine | TABLET, ORALLY DISINTEGRATING;ORAL | 090308-002 | Nov 25, 2015 | AB | RX | No | Yes | Start Trial | Start Trial | Start Trial | |||
| Ivax Sub Teva Pharms | CLOZAPINE | clozapine | TABLET;ORAL | 074949-003 | Jul 31, 2003 | RX | No | No | Start Trial | Start Trial | Start Trial | ||||
| Ivax Sub Teva Pharms | CLOZAPINE | clozapine | TABLET;ORAL | 076809-001 | Dec 16, 2005 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Mayne Pharma | CLOZAPINE | clozapine | TABLET;ORAL | 203807-001 | Sep 17, 2015 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Ivax Sub Teva Pharms | CLOZAPINE | clozapine | TABLET;ORAL | 076809-002 | Dec 16, 2005 | AB | RX | No | No | Start Trial | Start Trial | Start 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 | Start Trial | Start Trial |
| Jazz | FAZACLO ODT | clozapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021590-003 | Jun 3, 2005 | Start Trial | Start Trial |
| Jazz | FAZACLO ODT | clozapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021590-001 | Feb 10, 2004 | Start Trial | Start Trial |
| Jazz | FAZACLO ODT | clozapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021590-006 | Jul 9, 2010 | Start Trial | Start Trial |
| Jazz | FAZACLO ODT | clozapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021590-004 | May 30, 2007 | Start Trial | Start Trial |
| Jazz | FAZACLO ODT | clozapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021590-002 | Feb 10, 2004 | Start Trial | Start Trial |
| Jazz | FAZACLO ODT | clozapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021590-006 | Jul 9, 2010 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for clozapine
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Canada | 2532648 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2005007168 | Start Trial |
| European Patent Office | 1646393 | Start Trial |
| Australia | 2004257556 | Start Trial |
| Spain | 2436213 | Start Trial |
| New Zealand | 527142 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
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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.
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