FDA Orange Book · active-ingredient family
Lacosamide
Lacosamide is approved as 4 brand and 43 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:MOTPOLY XR · NDA 216185
4
Brand (NDA)
43
Generics (ANDA)
3
Listed patents
6
Exclusivity periods
Brand (NDA) products · capsule, extended release, solution, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MOTPOLY XRRLD×3 | AUCTA | NDA 216185 | — | May 04, 2023 | |
| VIMPATRLD | UCB INC | NDA 022255 | AA | Apr 20, 2010 | |
| VIMPATRLD | UCB INC | NDA 022254 | AP | Oct 28, 2008 | |
| VIMPATRLD×4 | UCB INC | NDA 022253 | AB | Oct 28, 2008 |
Generic (ANDA) products (43)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LACOSAMIDE | STERANCO HLTHCARE | ANDA 220366 | AA | May 21, 2026 | |
| LACOSAMIDE | REGCON HOLDINGS | ANDA 220386 | AA | Jan 29, 2026 | |
| LACOSAMIDE | GLENMARK PHARMS | ANDA 220268 | AP | Jan 21, 2026 | |
| LACOSAMIDE | AJENAT PHARMS | ANDA 219699 | AA | Jun 26, 2025 | |
| LACOSAMIDE | WESTMINSTER PHARMS | ANDA 218706 | AP | May 23, 2025 | |
| LACOSAMIDE | ACELLA | ANDA 218464 | AP | Nov 14, 2024 | |
| LACOSAMIDE | SOMERSET THERAPS LLC | ANDA 214960 | AP | Oct 09, 2024 | |
| LACOSAMIDE×4 | UNICHEM | ANDA 213109 | AB | Sep 04, 2024 | |
| LACOSAMIDE×4 | MACLEODS PHARMS LTD | ANDA 208466 | AB | May 24, 2024 | |
| LACOSAMIDE | CHARTWELL RX | ANDA 215154 | AA | May 15, 2024 | |
| LACOSAMIDE | HIKMA | ANDA 216806 | AP | Apr 05, 2024 | |
| LACOSAMIDE×4 | KANCHAN HLTHCARE | ANDA 218014 | AB | Apr 02, 2024 | |
| LACOSAMIDE | AMNEAL PHARMS | ANDA 204839 | — | Mar 27, 2024 | |
| LACOSAMIDE | DR REDDYS | ANDA 217718 | AP | Mar 25, 2024 | |
| LACOSAMIDE | HAINAN POLY | ANDA 217311 | AP | Feb 13, 2024 | |
| LACOSAMIDE | AUROBINDO PHARMA LTD | ANDA 209224 | AA | Jan 24, 2024 | |
| LACOSAMIDE | MSN | ANDA 215379 | AA | Dec 22, 2023 | |
| LACOSAMIDE×4 | ZYDUS PHARMS | ANDA 204947 | — | Dec 15, 2023 | |
| LACOSAMIDE | APOTEX | ANDA 216670 | AP | Nov 13, 2023 | |
| LACOSAMIDE | MSN | ANDA 215979 | AP | Feb 09, 2023 | |
| LACOSAMIDE | KANCHAN HLTHCARE | ANDA 216461 | AA | Feb 06, 2023 | |
| LACOSAMIDE×4 | ACTAVIS LABS FL INC | ANDA 204855 | — | Jan 05, 2023 | |
| LACOSAMIDE×4 | AUROBINDO PHARMA LTD | ANDA 204994 | AB | Jan 05, 2023 | |
| LACOSAMIDE | APOTEX | ANDA 206355 | — | Sep 26, 2022 | |
| LACOSAMIDE×4 | APOTEX | ANDA 214567 | — | Sep 23, 2022 | |
| LACOSAMIDE | GLAND | ANDA 215628 | AP | Sep 19, 2022 | |
| LACOSAMIDE | ASPIRO | ANDA 216335 | AP | Sep 14, 2022 | |
| LACOSAMIDE | NOVITIUM PHARMA | ANDA 216151 | AA | Aug 26, 2022 | |
| LACOSAMIDE×4 | ACCORD HLTHCARE | ANDA 205011 | — | Jul 12, 2022 | |
| LACOSAMIDE | ZYDUS PHARMS | ANDA 209465 | AP | Jun 29, 2022 | |
| LACOSAMIDE | HETERO LABS LTD III | ANDA 209301 | AA | May 31, 2022 | |
| LACOSAMIDE | ALKEM LABS LTD | ANDA 214672 | AA | May 19, 2022 | |
| LACOSAMIDE | FRESENIUS KABI USA | ANDA 214677 | AP | May 03, 2022 | |
| LACOSAMIDE | REGCON HOLDINGS | ANDA 214301 | AP | Apr 07, 2022 | |
| LACOSAMIDE×4 | ALKEM LABS LTD | ANDA 214695 | AB | Mar 31, 2022 | |
| LACOSAMIDE×4 | ALEMBIC | ANDA 204974 | AB | Mar 17, 2022 | |
| LACOSAMIDE×4 | AMNEAL PHARMS | ANDA 204857 | — | Mar 17, 2022 | |
| LACOSAMIDE×4 | GLENMARK PHARMS LTD | ANDA 205006 | AB | Mar 17, 2022 | |
| LACOSAMIDE×4 | HETERO LABS LTD V | ANDA 204787 | AB | Mar 17, 2022 | |
| LACOSAMIDE×4 | MSN LABS PVT LTD | ANDA 204921 | AB | Mar 17, 2022 | |
| LACOSAMIDE×4 | REGCON HOLDINGS | ANDA 208308 | AB | Mar 17, 2022 | |
| LACOSAMIDE×4 | SCIEGEN PHARMS | ANDA 205237 | AB | Mar 17, 2022 | |
| LACOSAMIDE×4 | SUN PHARM | ANDA 205031 | AB | Mar 17, 2022 |
Marketing exclusivity (6)
- D-188New indication / change exclusivity (3 years)
Apr 28, 2026
2 mo ago
- D-188New indication / change exclusivity (3 years)
Apr 28, 2026
2 mo ago
- D-188New indication / change exclusivity (3 years)
Apr 28, 2026
2 mo ago
- D-188New indication / change exclusivity (3 years)
Apr 28, 2026
2 mo ago
- D-188New indication / change exclusivity (3 years)
Apr 28, 2026
2 mo ago
- D-188New indication / change exclusivity (3 years)
Apr 28, 2026
2 mo ago
Listed patents (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11337943 | Jun 05, 2040 | in 14 yr 2 mo | ProductU-3660 |
| 12042474 | Jun 05, 2040 | in 14 yr 2 mo | ProductU-3660 |
| 11883374 | Jun 05, 2040 | in 14 yr 2 mo | ProductU-3660 |
Lacosamide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
