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, 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 twelve NDAs.
The generic ingredient in CLOZAPINE is clozapine. There are thirteen drug master file entries for this compound. Twelve 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.
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Questions you can ask:
- What is the 5 year forecast for CLOZAPINE?
- What are the global sales for CLOZAPINE?
- What is Average Wholesale Price for CLOZAPINE?
Summary for CLOZAPINE
| US Patents: | 0 |
| Applicants: | 10 |
| NDAs: | 12 |
| Finished Product Suppliers / Packagers: | 10 |
| Raw Ingredient (Bulk) Api Vendors: | 133 |
| Clinical Trials: | 183 |
| 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 |
|---|---|
| Intra-Cellular Therapies, Inc. | Phase 4 |
| Dr. Inge Winter | Phase 4 |
| Westfälische Wilhelms-Universität Münster | Phase 4 |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Par Pharm | CLOZAPINE | clozapine | TABLET;ORAL | 075162-001 | Apr 26, 2005 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Mylan | CLOZAPINE | clozapine | TABLET;ORAL | 075417-001 | May 27, 1999 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Par Pharm | CLOZAPINE | clozapine | TABLET;ORAL | 075162-002 | Apr 26, 2005 | 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 |
