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 |
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 |
Generic filers with tentative approvals for CLOZAPINE
Applicant | Application No. | Strength | Dosage Form |
⤷ Subscribe | ⤷ Subscribe | 200MG | TABLET, ORALLY DISINTEGRATING;ORAL |
⤷ Subscribe | ⤷ Subscribe | 150MG | TABLET, ORALLY DISINTEGRATING;ORAL |
⤷ Subscribe | ⤷ Subscribe | 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
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Jazz | FAZACLO ODT | clozapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021590-005 | Jul 9, 2010 | DISCN | Yes | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Jazz | FAZACLO ODT | clozapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021590-002 | Feb 10, 2004 | DISCN | Yes | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Barr Labs Inc | CLOZAPINE | clozapine | TABLET, ORALLY DISINTEGRATING;ORAL | 090308-002 | Nov 25, 2015 | AB | RX | No | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
Aurobindo Pharma | CLOZAPINE | clozapine | TABLET;ORAL | 206433-003 | Nov 29, 2016 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
>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 | 021590-003 | Jun 3, 2005 | ⤷ Subscribe | ⤷ Subscribe |
Jazz | FAZACLO ODT | clozapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021590-005 | Jul 9, 2010 | ⤷ Subscribe | ⤷ Subscribe |
Jazz | FAZACLO ODT | clozapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021590-006 | Jul 9, 2010 | ⤷ Subscribe | ⤷ Subscribe |
Jazz | FAZACLO ODT | clozapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021590-002 | Feb 10, 2004 | ⤷ Subscribe | ⤷ Subscribe |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for clozapine
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Canada | 2532648 | FORMULATION DE SUSPENSION STABLE DE CLOZAPINE (A STABLE CLOZAPINE SUSPENSION FORMULATION) | ⤷ Subscribe |
Australia | 2004257556 | A stable clozapine suspension formulation | ⤷ Subscribe |
Spain | 2436213 | ⤷ Subscribe | |
European Patent Office | 1646393 | FORMULATION DE SUSPENSION STABLE DE CLOZAPINE (A STABLE CLOZAPINE SUSPENSION FORMULATION) | ⤷ Subscribe |
>Country | >Patent Number | >Title | >Estimated Expiration |
Clozapine Market Analysis and Financial Projection Experimental
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