FDA Orange Book · active-ingredient family
Baclofen
Baclofen is approved as 7 brand and 42 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:FLEQSUVY · NDA 215602
7
Brand (NDA)
42
Generics (ANDA)
8
Listed patents
0
Exclusivity periods
Brand (NDA) products · granule, injectable, solution, suspension, tablet, tablet, orally disintegrating
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| FLEQSUVYRLD | AZURITY | NDA 215602 | AB | Feb 04, 2022 | |
| LYVISPAHRLD×3 | STRIDES PHARMA INTL | NDA 215422 | — | Nov 22, 2021 | |
| OZOBAXRLD×2 | METACEL PHARMS LLC | NDA 208193 | — | Sep 18, 2019 | |
| GABLOFENRLD×4 | PIRAMAL CRITICAL | NDA 022462 | AP | Nov 19, 2010 | |
| KEMSTRORLD×2 | UCB INC | NDA 021589 | — | Oct 30, 2003 | |
| LIORESALRLD×3 | AMNEAL | NDA 020075 | AP | Nov 07, 1996 | |
| LIORESALRLD×2 | NOVARTIS | NDA 017851 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (42)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BACLOFEN×3 | AUROBINDO PHARMA LTD | ANDA 214099 | AB | Nov 21, 2025 | |
| BACLOFEN×3 | SOMERSET THERAPS LLC | ANDA 090334 | AB | Jan 31, 2025 | |
| BACLOFEN×2 | RUBICON RESEARCH | ANDA 214445 | — | Dec 06, 2024 | |
| BACLOFEN×3 | RISING | ANDA 217788 | AB | Oct 24, 2024 | |
| BACLOFEN×3 | MICRO LABS | ANDA 217687 | AB | Nov 08, 2023 | |
| BACLOFEN×3 | REGCON HOLDINGS | ANDA 214114 | AB | Sep 19, 2023 | |
| BACLOFEN×2 | HERITAGE | ANDA 216309 | — | Aug 10, 2023 | |
| BACLOFEN | ANI PHARMS | ANDA 217252 | AB | Jun 08, 2023 | |
| BACLOFEN×3 | UNICHEM | ANDA 212067 | AB | Mar 09, 2023 | |
| BACLOFEN×3 | RUBICON RESEARCH | ANDA 217324 | AP | Feb 22, 2023 | |
| BACLOFEN×3 | MANKIND PHARMA | ANDA 215885 | AB | Jan 25, 2022 | |
| BACLOFEN×3 | HIBROW HLTHCARE | ANDA 211555 | AB | Nov 30, 2021 | |
| BACLOFEN×3 | LANNETT CO INC | ANDA 077241 | AB | Sep 22, 2021 | |
| BACLOFEN×3 | IMPAX | ANDA 077971 | — | Jul 07, 2021 | |
| BACLOFEN×3 | ANDAS 5 HOLDING | ANDA 212378 | AB | Apr 30, 2021 | |
| BACLOFEN×3 | RISING | ANDA 214374 | AB | Mar 05, 2021 | |
| BACLOFEN | MAIA PHARMS INC | ANDA 210777 | AP | Jan 15, 2021 | |
| BACLOFEN×4 | ZYDUS LIFESCIENCES | ANDA 211659 | AB | Apr 17, 2020 | |
| BACLOFEN×2 | MAIA PHARMS INC | ANDA 210048 | AP | Sep 11, 2019 | |
| BACLOFEN | MAIA PHARMS INC | ANDA 210315 | AP | Jul 30, 2019 | |
| BACLOFEN×2 | PHARMOBEDIENT | ANDA 209592 | AP | Mar 21, 2018 | |
| BACLOFEN | PHARMOBEDIENT | ANDA 209594 | AP | Mar 06, 2018 | |
| BACLOFEN×4 | RUBICON RESEARCH | ANDA 209102 | AB | Nov 28, 2017 | |
| BACLOFEN×3 | AMNEAL | ANDA 091193 | AP | May 03, 2016 | |
| BACLOFEN×2 | NORTHSTAR HLTHCARE | ANDA 078401 | AB | Sep 18, 2009 | |
| BACLOFEN×2 | OXFORD PHARMS | ANDA 077088 | AB | Oct 31, 2007 | |
| BACLOFEN×2 | SUN PHARM INDS INC | ANDA 077862 | — | Aug 14, 2006 | |
| BACLOFEN×2 | PH HEALTH | ANDA 077068 | AB | Aug 30, 2005 | |
| BACLOFEN | PHARMOBEDIENT | ANDA 077181 | — | Jul 29, 2005 | |
| BACLOFEN | PHARMOBEDIENT | ANDA 077121 | — | Jul 29, 2005 | |
| BACLOFEN×2 | WATSON LABS | ANDA 074698 | — | Aug 20, 1996 | |
| BACLOFEN×2 | YILING | ANDA 074584 | AB | Aug 19, 1996 | |
| BACLOFEN | WATSON LABS | ANDA 073092 | — | Jan 28, 1994 | |
| BACLOFEN | WATSON LABS | ANDA 073093 | — | Jan 28, 1994 | |
| BACLOFEN | TEVA | ANDA 073043 | — | Feb 27, 1992 | |
| BACLOFEN | TEVA | ANDA 073044 | — | Feb 27, 1992 | |
| BACLOFEN | WATSON LABS | ANDA 072824 | — | Sep 18, 1991 | |
| BACLOFEN | WATSON LABS | ANDA 072825 | — | Sep 18, 1991 | |
| BACLOFEN | IVAX SUB TEVA PHARMS | ANDA 072234 | AB | Jul 21, 1988 | |
| BACLOFEN | IVAX SUB TEVA PHARMS | ANDA 072235 | AB | Jul 21, 1988 | |
| BACLOFEN | USL PHARMA | ANDA 071260 | — | May 06, 1988 | |
| BACLOFEN | USL PHARMA | ANDA 071261 | — | May 06, 1988 |
Listed patents (8)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11446246 | Sep 08, 2037 | in 11 yr 5 mo | U-3433 |
| 11324696 | Sep 29, 2037 | in 11 yr 5 mo | Product |
| 10792262 | Jul 29, 2039 | in 13 yr 4 mo | ProductU-3263 |
| 11654124 | Jul 29, 2039 | in 13 yr 4 mo | Product |
| 11931328 | Jul 29, 2039 | in 13 yr 4 mo | Product |
| 10610502 | Aug 30, 2039 | in 13 yr 5 mo | U-2779 |
| 11850225 | Sep 29, 2041 | in 15 yr 6 mo | ProductU-3488 |
| 11491125 | Sep 29, 2041 | in 15 yr 6 mo | ProductU-3488 |
Baclofen — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
