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CLOBAZAM Drug Profile
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When do Clobazam patents expire, and when can generic versions of Clobazam launch?
Clobazam is a drug marketed by Amneal, Bionpharma Inc, Hetero Labs Ltd Iii, Hikma, Lannett Co Inc, Lupin Ltd, Mylan, Taro, Teva Pharms Usa, Upsher Smith Labs, Vistapharm, Accord Hlthcare, Alkem Labs Ltd, Amneal Pharms Co, Apotex, Breckenridge, Celltrion, Micro Labs, Piramal Hlthcare Uk, and Zydus Pharms. and is included in twenty-seven NDAs.
The generic ingredient in CLOBAZAM is clobazam. There are ten drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the clobazam profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Clobazam
A generic version of CLOBAZAM was approved as clobazam by AMNEAL on October 22nd, 2018.
Summary for CLOBAZAM
| US Patents: | 0 |
| Applicants: | 20 |
| NDAs: | 27 |
| Suppliers / Packagers: | 18 |
| Bulk Api Vendors: | 27 |
| Clinical Trials: | 21 |
| Patent Applications: | 3,774 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for CLOBAZAM |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for CLOBAZAM |
| DailyMed Link: | CLOBAZAM at DailyMed |
Recent Clinical Trials for CLOBAZAM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Greenwich Biosciences | Phase 1 |
| Northwell Health | Phase 1 |
| Besson Marie | Phase 2 |
Pharmacology for CLOBAZAM
| Drug Class | Benzodiazepine |
| Mechanism of Action | Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inducers |
US Patents and Regulatory Information for CLOBAZAM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Upsher Smith Labs | CLOBAZAM | clobazam | TABLET;ORAL | 209687-001 | Oct 22, 2018 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Lannett Co Inc | CLOBAZAM | clobazam | TABLET;ORAL | 212092-002 | Oct 30, 2019 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Hetero Labs Ltd Iii | CLOBAZAM | clobazam | TABLET;ORAL | 209795-002 | Oct 22, 2018 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Lupin Ltd | CLOBAZAM | clobazam | TABLET;ORAL | 210545-001 | Dec 14, 2018 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Hikma | CLOBAZAM | clobazam | TABLET;ORAL | 208785-001 | Oct 22, 2018 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Amneal | CLOBAZAM | clobazam | SUSPENSION;ORAL | 210039-001 | Oct 22, 2018 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Amneal Pharms Co | CLOBAZAM | clobazam | TABLET;ORAL | 209718-002 | Oct 22, 2018 | 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 |
