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Clobazamis the generic ingredient in three branded drugs marketed by Aquestive Therap, Amneal Pharms Llc, Bionpharma Inc, Hetero Labs Ltd Iii, Hikma, Lannett Co Inc, Lupin Ltd, Mylan, Taro, Teva Pharms Usa, Upsher Smith Labs, Vistapharm, Lundbeck Pharms Llc, Accord Hlthcare, Alkem Labs Ltd, Amneal Pharms Co, Apotex, Breckenridge, Micro Labs, Piramal Hlthcare Uk, and Zydus Pharms, and is included in twenty-nine NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.
Clobazam has one hundred and sixty-one patent family members in eighteen countries.
There are ten drug master file entries for clobazam. Twenty suppliers are listed for this compound.
Summary for clobazam
|Drug Master File Entries:||10|
|Suppliers / Packagers:||20|
|Bulk Api Vendors:||26|
|Formulation / Manufacturing:||see details|
|Drug Prices:||Drug price trends 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
|Besson Marie||Phase 2|
|Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.||Phase 3|
|Elizabeth Thiele||Phase 3|
Pharmacology for clobazam
|Drug Class||Benzodiazepine |
|Mechanism of Action||Cytochrome P450 2D6 Inhibitors |
Cytochrome P450 3A4 Inducers
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||TE||Type||RLD||RS||Patent No.||Patent Expiration||Product||Substance||Delist Req.||Exclusivity Expiration|
|Lupin Ltd||CLOBAZAM||clobazam||TABLET;ORAL||210545-002||Dec 14, 2018||AB||RX||No||No||Start Trial||Start Trial||Start Trial|
|Lundbeck Pharms Llc||ONFI||clobazam||TABLET;ORAL||202067-001||Oct 21, 2011||DISCN||No||No||Start Trial||Start Trial||Start Trial|
|Accord Hlthcare||CLOBAZAM||clobazam||TABLET;ORAL||212398-002||May 23, 2019||DISCN||No||No||Start Trial||Start Trial||Start Trial|
|Upsher Smith Labs||CLOBAZAM||clobazam||TABLET;ORAL||209687-002||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|
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