FDA Orange Book · active-ingredient family
Pregabalin
Pregabalin is approved as 3 brand and 52 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:LYRICA CR · NDA 209501
3
Brand (NDA)
52
Generics (ANDA)
6
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, solution, tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LYRICA CRRLD×3 | UPJOHN | NDA 209501 | AB | Oct 11, 2017 | |
| LYRICARLD | UPJOHN | NDA 022488 | AA | Jan 04, 2010 | |
| LYRICARLD×8 | UPJOHN | NDA 021446 | AB | Dec 30, 2004 |
Generic (ANDA) products (52)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PREGABALIN×8 | UNICHEM | ANDA 219593 | AB | Apr 30, 2026 | |
| PREGABALIN×8 | FOURRTS LABS | ANDA 218529 | AB | Feb 24, 2026 | |
| PREGABALIN×8 | JUBILANT GENERICS | ANDA 209530 | AB | May 20, 2025 | |
| PREGABALIN×8 | PHARMOBEDIENT | ANDA 091222 | AB | Feb 21, 2025 | |
| PREGABALIN×8 | TORRENT | ANDA 206942 | AB | Feb 21, 2025 | |
| PREGABALIN | AIPING PHARM INC | ANDA 217857 | AB | Jan 28, 2025 | |
| PREGABALIN×8 | MACLEODS PHARMS LTD | ANDA 205924 | — | Nov 12, 2024 | |
| PREGABALIN×8 | CHANGZHOU PHARM | ANDA 214322 | AB | Sep 26, 2024 | |
| PREGABALIN×8 | REGCON HOLDINGS | ANDA 208113 | AB | May 17, 2024 | |
| PREGABALIN×8 | STRIDES PHARMA | ANDA 209883 | — | Jan 24, 2024 | |
| PREGABALIN×8 | CADILA PHARMS LTD | ANDA 206452 | — | Jul 12, 2023 | |
| PREGABALIN×3 | EPIC PHARMA LLC | ANDA 214496 | AB | Jun 01, 2023 | |
| PREGABALIN×8 | STRIDES PHARMA | ANDA 215755 | AB | Apr 26, 2023 | |
| PREGABALIN×8 | AUROBINDO PHARMA | ANDA 205321 | AB | Mar 29, 2023 | |
| PREGABALIN×8 | ZYDUS PHARMS | ANDA 206752 | — | Dec 09, 2022 | |
| PREGABALIN×3 | SCIEGEN PHARMS | ANDA 215675 | — | Sep 14, 2022 | |
| PREGABALIN×8 | PRINSTON INC | ANDA 207883 | AB | Sep 01, 2022 | |
| PREGABALIN×3 | ZYDUS PHARMS | ANDA 215577 | — | Aug 26, 2022 | |
| PREGABALIN×8 | ADAPTIS | ANDA 216197 | AB | Jul 18, 2022 | |
| PREGABALIN×8 | LUPIN LTD | ANDA 091040 | — | May 03, 2022 | |
| PREGABALIN×3 | RUBICON RESEARCH | ANDA 215249 | AB | Mar 22, 2022 | |
| PREGABALIN×8 | ESKAYEF | ANDA 212988 | AB | Mar 08, 2022 | |
| PREGABALIN | PATRIN | ANDA 212604 | AA | Feb 18, 2022 | |
| PREGABALIN | PHARMOBEDIENT | ANDA 211967 | — | Nov 04, 2021 | |
| PREGABALIN×8 | APOTEX | ANDA 211685 | — | Jul 07, 2021 | |
| PREGABALIN×3 | ALVOGEN | ANDA 211687 | — | Jul 06, 2021 | |
| PREGABALIN | PHARMOBEDIENT | ANDA 211431 | — | Jul 02, 2021 | |
| PREGABALIN×3 | ALVOGEN | ANDA 211593 | — | Apr 13, 2021 | |
| PREGABALIN×2 | APOTEX | ANDA 213313 | — | Apr 13, 2021 | |
| PREGABALIN×3 | MSN | ANDA 213226 | AB | Apr 13, 2021 | |
| PREGABALIN | PHARMOBEDIENT | ANDA 211948 | — | Apr 13, 2021 | |
| PREGABALIN×3 | SUN PHARM | ANDA 211889 | — | Apr 13, 2021 | |
| PREGABALIN×8 | ACTAVIS ELIZABETH | ANDA 091025 | — | Jul 09, 2020 | |
| PREGABALIN×8 | CREEKWOOD PHARMS | ANDA 213423 | AB | Mar 23, 2020 | |
| PREGABALIN×4 | CHARTWELL RX | ANDA 212865 | AB | Mar 20, 2020 | |
| PREGABALIN×8 | CIPLA | ANDA 212280 | — | Jan 10, 2020 | |
| PREGABALIN×6 | RENATA | ANDA 210585 | AB | Dec 26, 2019 | |
| PREGABALIN×8 | SUN PHARM | ANDA 091157 | — | Nov 29, 2019 | |
| PREGABALIN×8 | HETERO LABS LTD III | ANDA 206912 | AB | Oct 08, 2019 | |
| PREGABALIN×8 | ALKEM LABS LTD | ANDA 207799 | AB | Sep 30, 2019 | |
| PREGABALIN×2 | YILING | ANDA 210891 | AB | Sep 30, 2019 | |
| PREGABALIN×8 | PHARMOBEDIENT | ANDA 091228 | — | Sep 20, 2019 | |
| PREGABALIN×8 | ALEMBIC | ANDA 203459 | AB | Jul 19, 2019 | |
| PREGABALIN×8 | AMNEAL PHARMS CO | ANDA 209743 | AB | Jul 19, 2019 | |
| PREGABALIN×8 | DR REDDYS | ANDA 209664 | AB | Jul 19, 2019 | |
| PREGABALIN×8 | INVAGEN PHARMS | ANDA 211384 | AB | Jul 19, 2019 | |
| PREGABALIN×8 | MSN | ANDA 209357 | AB | Jul 19, 2019 | |
| PREGABALIN×8 | RISING | ANDA 210432 | AB | Jul 19, 2019 | |
| PREGABALIN×8 | SCIEGEN PHARMS | ANDA 208677 | AB | Jul 19, 2019 | |
| PREGABALIN×2 | TEVA PHARMS | ANDA 091219 | — | Jul 19, 2019 | |
| PREGABALIN×6 | TEVA PHARMS | ANDA 091224 | — | Jul 19, 2019 | |
| PREGABALIN | ALKEM LABS LTD | ANDA 207623 | AA | Jul 19, 2019 |
Listed patents (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10022447 | Nov 02, 2026 | in 5 mo | U-2137 |
| 8945620 | Nov 02, 2026 | in 5 mo | ProductU-2136 |
| 9144559 | Nov 02, 2026 | in 5 mo | Product |
| 9144559*PED | May 02, 2027 | in 11 mo | |
| 10022447*PED | May 02, 2027 | in 11 mo | |
| 8945620*PED | May 02, 2027 | in 11 mo |
Pregabalin — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
