FDA Orange Book · active-ingredient family
Carbamazepine
Carbamazepine is approved as 7 brand and 44 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:CARNEXIV · NDA 206030
7
Brand (NDA)
44
Generics (ANDA)
7
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, extended release, solution, suspension, tablet, tablet, chewable, tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CARNEXIVRLD | LUNDBECK PHARMS LLC | NDA 206030 | — | Oct 07, 2016 | |
| EQUETRORLD×3 | VALIDUS PHARMS | NDA 021710 | — | Dec 10, 2004 | |
| CARBATROLRLD×3 | TAKEDA PHARMS USA | NDA 020712 | AB | Sep 30, 1997 | |
| TEGRETOL-XRRLD×3 | NOVARTIS | NDA 020234 | AB | Mar 25, 1996 | |
| TEGRETOLRLD | NOVARTIS | NDA 018927 | AB | Dec 18, 1987 | |
| TEGRETOLRLD | NOVARTIS | NDA 018281 | — | Approved Prior to Jan 1, 1982 | |
| TEGRETOLRLD | NOVARTIS | NDA 016608 | AB | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (44)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CARBAMAZEPINE×3 | ALEMBIC | ANDA 219939 | AB | Jul 25, 2025 | |
| CARBAMAZEPINE | ALEMBIC | ANDA 216623 | AB | Apr 16, 2025 | |
| CARBAMAZEPINE×3 | YICHANG HUMANWELL | ANDA 219072 | AB | Jan 16, 2025 | |
| CARBAMAZEPINE×3 | ALKEM LABS LTD | ANDA 217277 | AB | Jan 14, 2025 | |
| CARBAMAZEPINE×3 | TORRENT | ANDA 212524 | AB | Jan 13, 2025 | |
| CARBAMAZEPINE×3 | OSMOTICA PHARM US | ANDA 215664 | — | Oct 22, 2024 | |
| CARBAMAZEPINE×3 | APOTEX | ANDA 213159 | — | Mar 08, 2024 | |
| CARBAMAZEPINE | BIONPHARMA | ANDA 218221 | AB | Feb 16, 2024 | |
| CARBAMAZEPINE×3 | AMNEAL PHARMS | ANDA 212704 | — | Sep 22, 2023 | |
| CARBAMAZEPINE×3 | AJANTA PHARMA LTD | ANDA 216193 | — | Mar 24, 2023 | |
| CARBAMAZEPINE×3 | SCIECURE PHARMA INC | ANDA 216235 | AB | Mar 02, 2023 | |
| CARBAMAZEPINE×3 | INGENUS PHARMS LLC | ANDA 216404 | AB | Dec 02, 2022 | |
| CARBAMAZEPINE | NOVITIUM PHARMA | ANDA 214277 | AB | Oct 06, 2022 | |
| CARBAMAZEPINE | UNICHEM | ANDA 213284 | AB | Aug 22, 2022 | |
| CARBAMAZEPINE×3 | UMEDICA | ANDA 216594 | AB | Aug 18, 2022 | |
| CARBAMAZEPINE×3 | ZHEJIANG JIUZHOU | ANDA 215591 | AB | Mar 31, 2022 | |
| CARBAMAZEPINE×3 | ANBISON LAB | ANDA 212948 | AB | Sep 30, 2021 | |
| CARBAMAZEPINE | RK PHARMA | ANDA 214328 | — | Aug 16, 2021 | |
| CARBAMAZEPINE×3 | CSPC OUYI | ANDA 213311 | AB | Apr 13, 2021 | |
| CARBAMAZEPINE×3 | UNIQUE PHARM | ANDA 211623 | AB | Apr 24, 2020 | |
| CARBAMAZEPINE×2 | UMEDICA | ANDA 207798 | BX | Apr 15, 2020 | |
| CARBAMAZEPINE×3 | ZYDUS PHARMS | ANDA 205571 | AB | Feb 07, 2019 | |
| CARBAMAZEPINE×3 | TARO | ANDA 201106 | — | Jun 21, 2013 | |
| CARBAMAZEPINE×3 | TEVA PHARMS | ANDA 078592 | AB | Sep 20, 2012 | |
| CARBAMAZEPINE×3 | APOTEX INC | ANDA 078986 | AB | Nov 25, 2011 | |
| CARBAMAZEPINE×3 | ANI PHARMS | ANDA 076697 | AB | May 20, 2011 | |
| CARBAMAZEPINE×3 | TARO | ANDA 078115 | AB | Mar 31, 2009 | |
| CARBAMAZEPINE×4 | TORRENT PHARMS | ANDA 077272 | — | Dec 07, 2005 | |
| TERIL | TARO | ANDA 076729 | AB | Sep 20, 2004 | |
| TERIL | TARO | ANDA 076525 | — | Sep 26, 2003 | |
| CARBAMAZEPINE | CHARTWELL RX | ANDA 075714 | AB | Jun 05, 2002 | |
| CARBAMAZEPINE | APOTEX | ANDA 075948 | AB | Feb 27, 2002 | |
| CARBAMAZEPINE | TORRENT PHARMS | ANDA 075712 | AB | Jul 05, 2001 | |
| CARBAMAZEPINE | TARO | ANDA 075875 | — | Dec 21, 2000 | |
| CARBAMAZEPINE×2 | TARO PHARM INDS | ANDA 075687 | AB | Oct 24, 2000 | |
| CARBAMAZEPINE | TARO | ANDA 074649 | AB | Oct 03, 1996 | |
| EPITOL | TEVA | ANDA 073524 | AB | Jul 29, 1992 | |
| CARBAMAZEPINE | JUBILANT CADISTA | ANDA 071940 | — | Feb 01, 1988 | |
| CARBAMAZEPINE | ACTAVIS ELIZABETH | ANDA 071696 | — | Nov 09, 1987 | |
| CARBAMAZEPINE | PLIVA | ANDA 071479 | — | Jul 24, 1987 | |
| CARBAMAZEPINE | WARNER CHILCOTT | ANDA 070429 | — | Jan 02, 1987 | |
| EPITOL | TEVA | ANDA 070541 | AB | Sep 17, 1986 | |
| CARBAMAZEPINE | INWOOD LABS | ANDA 070231 | — | Aug 14, 1986 | |
| CARBAMAZEPINE | USL PHARMA | ANDA 070300 | — | May 15, 1986 |
Listed patents (7)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9629797 | Nov 10, 2028 | in 2 yr 5 mo | U-2004 |
| 9770407 | Nov 10, 2028 | in 2 yr 5 mo | Product |
| 7635773 | Mar 13, 2029 | in 2 yr 9 mo | Product |
| 9750822 | Mar 13, 2029 | in 2 yr 9 mo | Product |
| 8410077 | Mar 13, 2029 | in 2 yr 9 mo | Product |
| 9493582 | Feb 27, 2033 | in 6 yr 10 mo | Product |
| 11529357 | Jan 31, 2040 | in 13 yr 10 mo | Product |
Carbamazepine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
