CLOBAZAM Drug Patent Profile
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When do Clobazam patents expire, and when can generic versions of Clobazam launch?
Clobazam is a drug marketed by Accord Hlthcare, Alkem Labs Ltd, Amneal, Aurobindo Pharma Ltd, Bionpharma, Chartwell Molecular, Hetero Labs Ltd Iii, Hikma, Lupin Ltd, Norvium Bioscience, Taro, Teva Pharms Usa, Upsher Smith Labs, Vistapharm, Amneal Pharms Co, Anda Repository, Apotex, Breckenridge, Micro Labs, MSN, Piramal, and Zydus Pharms. and is included in thirty-one NDAs.
The generic ingredient in CLOBAZAM is clobazam. There are ten drug master file entries for this compound. Twenty-three 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.
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Summary for CLOBAZAM
| US Patents: | 0 |
| Applicants: | 22 |
| NDAs: | 31 |
| Finished Product Suppliers / Packagers: | 21 |
| Raw Ingredient (Bulk) Api Vendors: | 37 |
| Clinical Trials: | 26 |
| Patent Applications: | 3,812 |
| 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 |
|---|---|
| Dr Cipto Mangunkusumo General Hospital | Phase 4 |
| Wayne State University | Phase 4 |
| Jazz Pharmaceuticals | Phase 3 |
Pharmacology for CLOBAZAM
| Drug Class | Benzodiazepine |
| Mechanism of Action | Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inducers |
Anatomical Therapeutic Chemical (ATC) Classes for CLOBAZAM
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Msn | CLOBAZAM | clobazam | TABLET;ORAL | 213404-001 | May 11, 2021 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Chartwell Molecular | CLOBAZAM | clobazam | TABLET;ORAL | 212092-002 | Oct 30, 2019 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Zydus Pharms | CLOBAZAM | clobazam | TABLET;ORAL | 211449-001 | Oct 22, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Taro | CLOBAZAM | clobazam | TABLET;ORAL | 209440-001 | Oct 22, 2018 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Zydus Pharms | CLOBAZAM | clobazam | TABLET;ORAL | 211449-002 | Oct 22, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Breckenridge | CLOBAZAM | clobazam | TABLET;ORAL | 209308-003 | Oct 19, 2021 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hetero Labs Ltd Iii | CLOBAZAM | clobazam | TABLET;ORAL | 209795-001 | Oct 22, 2018 | AB | RX | 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 |
