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Last Updated: January 27, 2023

Clobazam - Generic Drug Details


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What are the generic 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 Inc, 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 two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Clobazam has one hundred and sixty-two patent family members in nineteen countries.

There are ten drug master file entries for clobazam. Twenty-five suppliers are listed for this compound.

Drug Prices for clobazam

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Recent Clinical Trials for clobazam

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Jazz PharmaceuticalsPhase 3
Northwell HealthPhase 1
Greenwich BiosciencesPhase 1

See all clobazam clinical trials

Pharmacology 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
Amneal Pharms Co CLOBAZAM clobazam TABLET;ORAL 209718-001 Oct 22, 2018 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Lundbeck Pharms Llc ONFI clobazam TABLET;ORAL 202067-001 Oct 21, 2011 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Msn CLOBAZAM clobazam TABLET;ORAL 213404-002 May 11, 2021 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Breckenridge CLOBAZAM clobazam TABLET;ORAL 209308-003 Oct 19, 2021 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Zydus Pharms CLOBAZAM clobazam TABLET;ORAL 211449-001 Oct 22, 2018 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Chartwell Molecular CLOBAZAM clobazam SUSPENSION;ORAL 213110-001 Apr 24, 2020 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hikma CLOBAZAM clobazam TABLET;ORAL 208785-001 Oct 22, 2018 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for clobazam

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 03046630 See Plans and Pricing
Australia 2018205083 SUBLINGUAL AND BUCCAL FILM COMPOSITIONS See Plans and Pricing
Japan 2011093936 THIN FILM WITH NON-SELF-AGGREGATING UNIFORM HETEROGENEITY, METHOD FOR PRODUCING THE SAME, AND DRUG DELIVERY SYSTEM MADE THEREFROM See Plans and Pricing
China 101321511 Topical film compositions for delivery of actives See Plans and Pricing
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) See Plans and Pricing
European Patent Office 3210601 FILMS À BASE D'OXYDE DE POLYÉTHYLÈNE ET SYSTÈMES D'ADMINISTRATION DE MÉDICAMENT FABRIQUÉS À PARTIR DE CEUX-CI (POLYETHYLENE OXIDE-BASED FILMS AND DRUG DELIVERY SYSTEM MADE THEREFROM) See Plans and Pricing
European Patent Office 2351557 FILM MINCE DOTÉ D'UNE HÉTÉROGÉNÉITÉ UNIFORME NON AUTO-REGROUPANT, SON PROCÉDÉ DE PRÉPARATION ET SYSTÈMES D'ADMINISTRATION DE MÉDICAMENTS CORRESPONDANTS (THIN FILM WITH NON-SELF-AGGREGATING UNIFORM HETEROGENEITY, PROCESS FOR THER PRODUCTION AND DRUG DELIVERY SYSTEMS MADE THEREFROM) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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