FDA Orange Book · active-ingredient family
Clobazam
Clobazam is approved as 3 brand and 31 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:SYMPAZAN · NDA 210833
3
Brand (NDA)
31
Generics (ANDA)
3
Listed patents
0
Exclusivity periods
Brand (NDA) products · film, suspension, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SYMPAZANRLD×3 | ASSERTIO SPECLTY | NDA 210833 | — | Nov 01, 2018 | |
| ONFIRLD | LUNDBECK PHARMS LLC | NDA 203993 | AB | Dec 14, 2012 | |
| ONFIRLD×3 | LUNDBECK PHARMS LLC | NDA 202067 | — | Oct 21, 2011 |
Generic (ANDA) products (31)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CLOBAZAM | ACCORD HLTHCARE | ANDA 216008 | — | Sep 06, 2022 | |
| CLOBAZAM | AUROBINDO PHARMA LTD | ANDA 214404 | AB | Mar 24, 2022 | |
| CLOBAZAM×3 | NOVITIUM PHARMA | ANDA 209308 | — | Oct 19, 2021 | |
| CLOBAZAM×2 | MSN | ANDA 213404 | AB | May 11, 2021 | |
| CLOBAZAM | ALKEM LABS LTD | ANDA 213039 | AB | May 06, 2021 | |
| CLOBAZAM×3 | ALKEM LABS LTD | ANDA 212714 | — | Dec 21, 2020 | |
| CLOBAZAM×2 | CHARTWELL RX | ANDA 211959 | — | Dec 09, 2020 | |
| CLOBAZAM×2 | APOTEX | ANDA 209853 | — | Jun 09, 2020 | |
| CLOBAZAM | CHARTWELL MOLECULAR | ANDA 213110 | AB | Apr 24, 2020 | |
| CLOBAZAM | HETERO LABS LTD III | ANDA 209796 | AB | Feb 24, 2020 | |
| CLOBAZAM | TEVA PHARMS USA | ANDA 211032 | — | Jan 31, 2020 | |
| CLOBAZAM×2 | CHARTWELL MOLECULAR | ANDA 212092 | — | Oct 30, 2019 | |
| CLOBAZAM | VISTAPHARM LLC | ANDA 210746 | — | Jul 10, 2019 | |
| CLOBAZAM×2 | ACCORD HLTHCARE | ANDA 212398 | — | May 23, 2019 | |
| CLOBAZAM | TARO | ANDA 210978 | AB | Apr 15, 2019 | |
| CLOBAZAM×2 | MICRO LABS | ANDA 211711 | AB | Jan 30, 2019 | |
| CLOBAZAM | LUPIN | ANDA 210546 | — | Dec 28, 2018 | |
| CLOBAZAM×2 | LUPIN | ANDA 210545 | AB | Dec 14, 2018 | |
| CLOBAZAM | AMNEAL | ANDA 210039 | AB | Oct 22, 2018 | |
| CLOBAZAM | BIONPHARMA | ANDA 208819 | AB | Oct 22, 2018 | |
| CLOBAZAM | HIKMA | ANDA 209715 | — | Oct 22, 2018 | |
| CLOBAZAM | PHARMOBEDIENT | ANDA 211259 | — | Oct 22, 2018 | |
| CLOBAZAM | UPSHER SMITH LABS | ANDA 210569 | — | Oct 22, 2018 | |
| CLOBAZAM×2 | AMNEAL PHARMS CO | ANDA 209718 | AB | Oct 22, 2018 | |
| CLOBAZAM×2 | BIONPHARMA | ANDA 208825 | AB | Oct 22, 2018 | |
| CLOBAZAM×2 | HETERO LABS LTD III | ANDA 209795 | AB | Oct 22, 2018 | |
| CLOBAZAM×2 | HIKMA | ANDA 208785 | — | Oct 22, 2018 | |
| CLOBAZAM×2 | PIRAMAL | ANDA 209808 | AB | Oct 22, 2018 | |
| CLOBAZAM×2 | TARO | ANDA 209440 | — | Oct 22, 2018 | |
| CLOBAZAM×2 | UPSHER SMITH LABS | ANDA 209687 | AB | Oct 22, 2018 | |
| CLOBAZAM×2 | ZYDUS PHARMS | ANDA 211449 | AB | Oct 22, 2018 |
Listed patents (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 12403090 | Sep 05, 2039 | in 13 yr 5 mo | ProductU-724 |
| 12290597 | Sep 05, 2039 | in 13 yr 5 mo | ProductU-724 |
| 11541002 | Jan 31, 2040 | in 13 yr 10 mo | ProductU-724 |
Clobazam — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
