CLOZAPINE Drug Patent Profile
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Which patents cover Clozapine, and when can generic versions of Clozapine launch?
Clozapine is a drug marketed by Barr Labs Inc, Mylan, Teva Pharms Usa, Accord Hlthcare, Aurobindo Pharma, Dr Reddys Labs Sa, Ivax Sub Teva Pharms, Par Pharm, Sandoz, Sun Pharm Inds Inc, and Zydus Pharms. and is included in thirteen NDAs.
The generic ingredient in CLOZAPINE is clozapine. There are thirteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the clozapine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Clozapine
A generic version of CLOZAPINE was approved as clozapine by IVAX SUB TEVA PHARMS on November 26th, 1997.
Summary for CLOZAPINE
US Patents: | 0 |
Applicants: | 11 |
NDAs: | 13 |
Finished Product Suppliers / Packagers: | 13 |
Raw Ingredient (Bulk) Api Vendors: | 133 |
Clinical Trials: | 182 |
Patent Applications: | 4,378 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information 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 |
---|---|
Westfälische Wilhelms-Universität Münster | Phase 4 |
Dr. Inge Winter | Phase 4 |
First Affiliated Hospital Xi'an Jiaotong University | N/A |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Zydus Pharms | CLOZAPINE | clozapine | TABLET;ORAL | 209480-002 | Dec 6, 2017 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Par Pharm | CLOZAPINE | clozapine | TABLET;ORAL | 075162-001 | Apr 26, 2005 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Mylan | CLOZAPINE | clozapine | TABLET;ORAL | 075417-001 | May 27, 1999 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Par Pharm | CLOZAPINE | clozapine | TABLET;ORAL | 075162-002 | Apr 26, 2005 | DISCN | 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 |