Is there a generic for Clobazam?

Yes. The FDA Orange Book lists 31 approved generic (ANDA) applications for Clobazam, referencing the brand SYMPAZAN. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Clobazam?

SYMPAZAN (NDA 210833, COSETTE) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Clobazam?

The Orange Book lists 3 patents against Clobazam products, with the earliest listed expiry in 2039. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Clobazam are approved?

Clobazam is approved in the following dosage forms: film, suspension, tablet.

FDA Orange Book · active-ingredient family

Clobazam

Clobazam: 3 brands, 31 generics; first approved Oct 21, 2011; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 31 ANDA applications approved.

Earliest patent expiry Sep 05, 2039

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Sep 05, 2039

in 13 yr 3 mo

Brand (NDA) products

Originator applications

SYMPAZANRLD
COSETTENDA 21083320183 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG FILM ORAL Rx —
10MG FILM ORAL Rx —
20MG FILM ORAL Rx —
ONFIRLDRS
LUNDBECK PHARMS LLCNDA 2039932012
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG/ML SUSPENSION ORAL Rx AB
ONFIRLD
LUNDBECK PHARMS LLCNDA 20206720113 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Discontinued —
10MG TABLET ORAL Rx AB
20MG TABLET ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	FILM	ORAL	Rx	—
10MG	FILM	ORAL	Rx	—
20MG	FILM	ORAL	Rx	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG/ML	SUSPENSION	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Discontinued	—
10MG	TABLET	ORAL	Rx	AB
20MG	TABLET	ORAL	Rx	AB

Generic (ANDA) products (31)

Abbreviated applications

CLOBAZAM
ACCORD HLTHCAREANDA 2160082022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG/ML SUSPENSION ORAL Discontinued —
CLOBAZAM
AUROBINDO PHARMA LTDANDA 2144042022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG/ML SUSPENSION ORAL Rx AB
CLOBAZAM
NOVITIUM PHARMAANDA 20930820213 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Discontinued —
20MG TABLET ORAL Discontinued —
5MG TABLET ORAL Discontinued —
CLOBAZAM
MSNANDA 21340420212 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Rx AB
20MG TABLET ORAL Rx AB
CLOBAZAM
ALKEM LABS LTDANDA 2130392021
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG/ML SUSPENSION ORAL Rx AB
CLOBAZAM
ALKEM LABS LTDANDA 21271420203 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Rx AB
20MG TABLET ORAL Rx AB
5MG TABLET ORAL Rx —
CLOBAZAM
CHARTWELL RXANDA 21195920202 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Discontinued —
20MG TABLET ORAL Discontinued —
CLOBAZAM
APOTEXANDA 20985320202 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Discontinued —
20MG TABLET ORAL Discontinued —
CLOBAZAM
CHARTWELL MOLECULARANDA 2131102020
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG/ML SUSPENSION ORAL Rx AB
CLOBAZAM
HETERO LABS LTD IIIANDA 2097962020
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG/ML SUSPENSION ORAL Rx AB
CLOBAZAM
TEVA PHARMS USAANDA 2110322020
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG/ML SUSPENSION ORAL Discontinued —
CLOBAZAM
CHARTWELL MOLECULARANDA 21209220192 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Discontinued —
20MG TABLET ORAL Discontinued —
CLOBAZAM
VISTAPHARM LLCANDA 2107462019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG/ML SUSPENSION ORAL Discontinued —
CLOBAZAM
ACCORD HLTHCAREANDA 21239820192 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Discontinued —
20MG TABLET ORAL Discontinued —
CLOBAZAM
TAROANDA 2109782019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG/ML SUSPENSION ORAL Rx AB
CLOBAZAM
MICRO LABSANDA 21171120192 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Rx AB
20MG TABLET ORAL Rx AB
CLOBAZAM
LUPINANDA 2105462018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG/ML SUSPENSION ORAL Discontinued —
CLOBAZAM
LUPINANDA 21054520182 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Rx AB
20MG TABLET ORAL Rx AB
CLOBAZAM
AMNEALANDA 2100392018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG/ML SUSPENSION ORAL Rx AB
CLOBAZAM
BIONPHARMAANDA 2088192018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG/ML SUSPENSION ORAL Rx AB
CLOBAZAM
HIKMAANDA 2097152018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG/ML SUSPENSION ORAL Discontinued —
CLOBAZAM
PHARMOBEDIENTANDA 2112592018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG/ML SUSPENSION ORAL Discontinued —
CLOBAZAM
UPSHER SMITH LABSANDA 2105692018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG/ML SUSPENSION ORAL Discontinued —
CLOBAZAM
AMNEAL PHARMS COANDA 20971820182 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Rx AB
20MG TABLET ORAL Rx AB
CLOBAZAM
BIONPHARMAANDA 20882520182 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Rx AB
20MG TABLET ORAL Rx AB
CLOBAZAM
HETERO LABS LTD IIIANDA 20979520182 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Rx AB
20MG TABLET ORAL Rx AB
CLOBAZAM
HIKMAANDA 20878520182 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Discontinued —
20MG TABLET ORAL Discontinued —
CLOBAZAM
PIRAMALANDA 20980820182 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Rx AB
20MG TABLET ORAL Rx AB
CLOBAZAM
TAROANDA 20944020182 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Discontinued —
20MG TABLET ORAL Discontinued —
CLOBAZAM
UPSHER SMITH LABSANDA 20968720182 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Rx AB
20MG TABLET ORAL Rx AB
CLOBAZAM
ZYDUS PHARMSANDA 21144920182 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Rx AB
20MG TABLET ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG/ML	SUSPENSION	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG/ML	SUSPENSION	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Discontinued	—
20MG	TABLET	ORAL	Discontinued	—
5MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Rx	AB
20MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG/ML	SUSPENSION	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Rx	AB
20MG	TABLET	ORAL	Rx	AB
5MG	TABLET	ORAL	Rx	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Discontinued	—
20MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Discontinued	—
20MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG/ML	SUSPENSION	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG/ML	SUSPENSION	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG/ML	SUSPENSION	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Discontinued	—
20MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG/ML	SUSPENSION	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Discontinued	—
20MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG/ML	SUSPENSION	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Rx	AB
20MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG/ML	SUSPENSION	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Rx	AB
20MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG/ML	SUSPENSION	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG/ML	SUSPENSION	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG/ML	SUSPENSION	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG/ML	SUSPENSION	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG/ML	SUSPENSION	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Rx	AB
20MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Rx	AB
20MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Rx	AB
20MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Discontinued	—
20MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Rx	AB
20MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Discontinued	—
20MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Rx	AB
20MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Rx	AB
20MG	TABLET	ORAL	Rx	AB

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Listed patents

Orange Book patent file

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
12403090	Sep 05, 2039	in 13 yr 3 mo	ProductU-724
12290597	Sep 05, 2039	in 13 yr 3 mo	ProductU-724
11541002	Jan 31, 2040	in 13 yr 8 mo	ProductU-724

Approval history

FDA approval span

First approval

Oct 21, 2011

15 yr 1 mo ago

Most recent approval

Sep 06, 2022

4 yr ago

Approvals span 2011–2022 across 34 FDA applications.

Brand (NDA) 39%

Generic (ANDA) 3191%

Clobazam: frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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