FDA Orange Book · active-ingredient family
Oxcarbazepine
Oxcarbazepine is approved as 3 brand and 32 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:OXTELLAR XR · NDA 202810
3
Brand (NDA)
32
Generics (ANDA)
11
Listed patents
0
Exclusivity periods
Brand (NDA) products · suspension, tablet, tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| OXTELLAR XRRLD×3 | SUPERNUS PHARMS | NDA 202810 | AB | Oct 19, 2012 | |
| TRILEPTALRLD | NOVARTIS | NDA 021285 | AB | May 25, 2001 | |
| TRILEPTALRLD×3 | NOVARTIS | NDA 021014 | AB | Jan 14, 2000 |
Generic (ANDA) products (32)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| OXCARBAZEPINE | MSN | ANDA 209020 | AB | May 29, 2026 | |
| OXCARBAZEPINE×3 | UMEDICA LABS PVT | ANDA 218341 | AB | Apr 29, 2026 | |
| OXCARBAZEPINE | STERANCO HLTHCARE | ANDA 220281 | AB | Mar 09, 2026 | |
| OXCARBAZEPINE×3 | EPIC PHARMA LLC | ANDA 219556 | AB | Mar 02, 2026 | |
| OXCARBAZEPINE | MACLEODS PHARMS LTD | ANDA 207300 | AB | Jul 11, 2025 | |
| OXCARBAZEPINE×3 | AUROBINDO PHARMA LTD | ANDA 219241 | — | Apr 30, 2025 | |
| OXCARBAZEPINE×3 | RICONPHARMA LLC | ANDA 215796 | AB | Nov 22, 2024 | |
| OXCARBAZEPINE×3 | RUBICON RESEARCH | ANDA 207717 | AB | Mar 05, 2024 | |
| OXCARBAZEPINE | BIOCON PHARMA | ANDA 218278 | AB | Mar 01, 2024 | |
| OXCARBAZEPINE×3 | AJANTA PHARMA LTD | ANDA 217659 | AB | Feb 22, 2024 | |
| OXCARBAZEPINE | KANCHAN HLTHCARE | ANDA 217782 | AB | Feb 14, 2024 | |
| OXCARBAZEPINE | HETERO LABS LTD III | ANDA 216749 | AB | Oct 20, 2023 | |
| OXCARBAZEPINE×3 | APOTEX | ANDA 213369 | AB | Jul 13, 2023 | |
| OXCARBAZEPINE×3 | ZYDUS | ANDA 211747 | — | Jul 03, 2023 | |
| OXCARBAZEPINE | ALKEM LABS LTD | ANDA 213183 | AB | Mar 18, 2023 | |
| OXCARBAZEPINE | AUCTA | ANDA 215332 | AB | Nov 30, 2022 | |
| OXCARBAZEPINE | BIONPHARMA | ANDA 209652 | AB | Nov 04, 2022 | |
| OXCARBAZEPINE | RUBICON RESEARCH | ANDA 215726 | AB | Aug 30, 2022 | |
| OXCARBAZEPINE×3 | ANNORA PHARMA | ANDA 215939 | AB | Jan 11, 2022 | |
| OXCARBAZEPINE | PAI HOLDINGS | ANDA 211420 | — | Jul 09, 2021 | |
| OXCARBAZEPINE | CHARTWELL RX | ANDA 212428 | AB | Jun 21, 2021 | |
| OXCARBAZEPINE | HIKMA | ANDA 201193 | — | Oct 03, 2012 | |
| OXCARBAZEPINE | AMNEAL PHARMS | ANDA 202961 | AB | Sep 17, 2012 | |
| OXCARBAZEPINE×3 | JUBILANT CADISTA | ANDA 090239 | — | Jan 25, 2010 | |
| OXCARBAZEPINE | SUN PHARM INDS LTD | ANDA 078734 | AB | Jun 26, 2009 | |
| OXCARBAZEPINE×3 | RUBICON RESEARCH | ANDA 077747 | AB | Apr 09, 2008 | |
| OXCARBAZEPINE×3 | BRECKENRIDGE PHARM | ANDA 078069 | AB | Jan 11, 2008 | |
| OXCARBAZEPINE×3 | ANI PHARMS | ANDA 078005 | AB | Dec 11, 2007 | |
| OXCARBAZEPINE×3 | TARO | ANDA 077801 | AB | Nov 15, 2007 | |
| OXCARBAZEPINE×3 | GLENMARK PHARMS LTD | ANDA 077802 | AB | Oct 09, 2007 | |
| OXCARBAZEPINE×3 | HIKMA | ANDA 077795 | — | Oct 09, 2007 | |
| OXCARBAZEPINE×3 | SUN PHARM INDS | ANDA 077794 | AB | Oct 09, 2007 |
Listed patents (11)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10220042 | Apr 13, 2027 | in 10 mo | U-2501 |
| 7910131 | Apr 13, 2027 | in 10 mo | U-2041 |
| 9119791 | Apr 13, 2027 | in 10 mo | U-2041 |
| 11896599 | Apr 13, 2027 | in 10 mo | Product |
| 9855278 | Apr 13, 2027 | in 10 mo | Product |
| 7722898 | Apr 13, 2027 | in 10 mo | Product |
| 8821930 | Apr 13, 2027 | in 10 mo | Product |
| 8617600 | Apr 13, 2027 | in 10 mo | Product |
| 11166960 | Apr 13, 2027 | in 10 mo | Product |
| 9370525 | Apr 13, 2027 | in 10 mo | Product |
| 9351975 | Apr 13, 2027 | in 10 mo | Product |
Oxcarbazepine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
