Clobazam - Generic Drug Details
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What are the generic drug sources for clobazam and what is the scope of patent protection?
Clobazam
is the generic ingredient in three branded drugs marketed by Otter Pharms, Accord Hlthcare, Alkem Labs Ltd, Amneal, Aurobindo Pharma Ltd, Bionpharma, Chartwell Molecular, Hetero Labs Ltd Iii, Hikma, Lupin Ltd, Mylan, Taro, Teva Pharms Usa, Upsher Smith Labs, Vistapharm, Lundbeck Pharms Llc, Amneal Pharms Co, Apotex, Breckenridge, Celltrion, Micro Labs, MSN, Piramal Hlthcare Uk, and Zydus Pharms, and is included in thirty-four NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Clobazam has one hundred and sixty-eight patent family members in nineteen countries.
There are ten drug master file entries for clobazam. Twenty-three suppliers are listed for this compound.
Summary for clobazam
International Patents: | 168 |
US Patents: | 3 |
Tradenames: | 3 |
Applicants: | 24 |
NDAs: | 34 |
Drug Master File Entries: | 10 |
Finished Product Suppliers / Packagers: | 23 |
Raw Ingredient (Bulk) Api Vendors: | 37 |
Clinical Trials: | 26 |
Patent Applications: | 6,097 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for clobazam |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for clobazam |
What excipients (inactive ingredients) are in clobazam? | clobazam excipients list |
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 |
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Amneal Pharms Co | CLOBAZAM | clobazam | TABLET;ORAL | 209718-002 | Oct 22, 2018 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Accord Hlthcare | CLOBAZAM | clobazam | TABLET;ORAL | 212398-002 | May 23, 2019 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Aurobindo Pharma Ltd | CLOBAZAM | clobazam | SUSPENSION;ORAL | 214404-001 | Mar 24, 2022 | AB | RX | 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 |
Expired US Patents for clobazam
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Otter Pharms | SYMPAZAN | clobazam | FILM;ORAL | 210833-002 | Nov 1, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
Otter Pharms | SYMPAZAN | clobazam | FILM;ORAL | 210833-001 | Nov 1, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
Otter Pharms | SYMPAZAN | clobazam | FILM;ORAL | 210833-002 | Nov 1, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
Otter Pharms | SYMPAZAN | clobazam | FILM;ORAL | 210833-001 | Nov 1, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for clobazam
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 2004530928 | ⤷ Try a Trial | |
European Patent Office | 2079457 | PROCÉDÉ DESTINÉ À ADMINISTRER UN PRODUIT EN FILM CONTENANT UN MÉDICAMENT (A METHOD OF ADMINISTERING A FILM PRODUCT CONTAINING A DRUG) | ⤷ Try a Trial |
Japan | 2011140507 | UNIFORM FILM FOR RAPID-DISSOLVE DOSAGE FORM INCORPORATING TASTE-MASKING COMPOSITION | ⤷ Try a Trial |
Denmark | 2332523 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
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