FDA Orange Book · active-ingredient family
Gabapentin
Gabapentin is approved as 4 brand and 69 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:GRALISE · NDA 022544
4
Brand (NDA)
69
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, solution, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| GRALISERLD×5 | ALMATICA | NDA 022544 | AB2 | Jan 28, 2011 | |
| NEURONTINRLD | VIATRIS | NDA 021129 | AA | Mar 02, 2000 | |
| NEURONTINRLD×2 | VIATRIS | NDA 020882 | AB1 | Oct 09, 1998 | |
| NEURONTINRLD×3 | VIATRIS | NDA 020235 | AB | Dec 30, 1993 |
Generic (ANDA) products (69)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| GABAPENTIN×3 | PRINSTON INC | ANDA 219814 | AB | Mar 06, 2026 | |
| GABAPENTIN×2 | SCIEGEN PHARMS | ANDA 218491 | AB2 | Sep 19, 2025 | |
| GABAPENTIN×4 | SENORES PHARMS | ANDA 219319 | AB | Aug 07, 2025 | |
| GABAPENTIN×4 | STRIDES PHARMA | ANDA 211313 | AB1 | Dec 20, 2024 | |
| GABAPENTIN | ABON PHARMS LLC | ANDA 203643 | AB2 | Sep 09, 2024 | |
| GABAPENTIN×2 | IPCA LABS LTD | ANDA 209855 | — | May 29, 2024 | |
| GABAPENTIN×2 | LAURUS | ANDA 217965 | AB1 | Apr 08, 2024 | |
| GABAPENTIN×2 | ANNORA PHARMA | ANDA 218075 | AB2 | Feb 26, 2024 | |
| GABAPENTIN×2 | EPIC PHARMA LLC | ANDA 216252 | AB2 | Feb 26, 2024 | |
| GABAPENTIN×5 | ZYDUS PHARMS | ANDA 203934 | AB2 | Jan 24, 2024 | |
| GABAPENTIN | ANNORA PHARMA | ANDA 217682 | AA | Jan 17, 2024 | |
| GABAPENTIN×3 | IPCA LABS LTD | ANDA 208928 | — | Nov 20, 2023 | |
| GABAPENTIN×2 | RISING | ANDA 217995 | AB1 | Jul 19, 2023 | |
| GABAPENTIN×3 | LAURUS | ANDA 217546 | AB | May 12, 2023 | |
| GABAPENTIN×2 | GRANULES | ANDA 217116 | AB1 | Mar 28, 2023 | |
| GABAPENTIN | RUBICON RESEARCH | ANDA 216492 | AA | Jan 18, 2023 | |
| GABAPENTIN×2 | ASCENT PHARMS INC | ANDA 214957 | AB1 | Oct 01, 2021 | |
| GABAPENTIN×3 | ASCENT PHARMS INC | ANDA 214956 | AB | May 10, 2021 | |
| GABAPENTIN×3 | ZHEJIANG YONGTAI | ANDA 213603 | AB | Aug 17, 2020 | |
| GABAPENTIN | PAI HOLDINGS PHARM | ANDA 211330 | AA | Dec 03, 2019 | |
| GABAPENTIN×3 | STRIDES PHARMA | ANDA 211314 | AB | Oct 16, 2018 | |
| GABAPENTIN×2 | LUPIN | ANDA 209306 | — | Aug 24, 2018 | |
| GABAPENTIN×3 | STRIDES PHARMA | ANDA 206943 | AB | May 14, 2018 | |
| GABAPENTIN×3 | CHARTWELL RX | ANDA 091008 | — | Oct 26, 2017 | |
| GABAPENTIN×2 | CSPC OUYI | ANDA 207057 | AB1 | Oct 26, 2017 | |
| GABAPENTIN×3 | RISING | ANDA 207099 | AB | Mar 24, 2017 | |
| GABAPENTIN×2 | TEVA PHARMS USA | ANDA 205807 | — | Mar 10, 2017 | |
| GABAPENTIN | AJENAT PHARMS | ANDA 091286 | AA | Mar 14, 2016 | |
| RELGAABI×4 | SCIEGEN PHARMS | ANDA 204989 | AB | Feb 18, 2016 | |
| GABAPENTIN×2 | SCIEGEN PHARMS | ANDA 205101 | AB1 | Feb 04, 2016 | |
| GABAPENTIN×2 | ALKEM LABS LTD | ANDA 206402 | AB1 | Dec 23, 2015 | |
| GABAPENTIN×3 | TARO | ANDA 077261 | — | Aug 02, 2013 | |
| GABAPENTIN×2 | STRIDES PHARMA | ANDA 203244 | AB1 | Jul 12, 2013 | |
| GABAPENTIN | TARO | ANDA 076672 | — | Jul 03, 2013 | |
| GABAPENTIN×2 | INVAGEN PHARMS | ANDA 202764 | — | Oct 16, 2012 | |
| GABAPENTIN | ACELLA PHARMS LLC | ANDA 076403 | AA | May 01, 2012 | |
| GABAPENTIN | AMNEAL PHARMS | ANDA 202024 | AA | Mar 23, 2012 | |
| GABAPENTIN×2 | AUROBINDO PHARMA LTD | ANDA 200651 | AB1 | Oct 06, 2011 | |
| GABAPENTIN×3 | MARKSANS PHARMA | ANDA 090007 | AB | Jul 21, 2011 | |
| GABAPENTIN×2 | HIKMA PHARMS | ANDA 078782 | — | Jul 21, 2011 | |
| GABAPENTIN | MISSION PHARMACAL | ANDA 078974 | AA | Feb 18, 2011 | |
| GABAPENTIN×3 | PHARMOBEDIENT | ANDA 090158 | — | Feb 14, 2011 | |
| GABAPENTIN×2 | ZYDUS PHARMS USA INC | ANDA 078926 | AB1 | Feb 11, 2011 | |
| GABAPENTIN×3 | ALKEM | ANDA 090858 | AB | Dec 17, 2010 | |
| GABAPENTIN×2 | PHARMOBEDIENT | ANDA 090335 | — | Jun 01, 2010 | |
| GABAPENTIN×3 | INVAGEN PHARMS | ANDA 090705 | AB | Dec 30, 2009 | |
| GABAPENTIN×3 | AUROBINDO PHARMA | ANDA 078787 | AB | Jan 31, 2008 | |
| GABAPENTIN×3 | HIKMA | ANDA 078150 | — | Sep 25, 2007 | |
| GABAPENTIN×3 | AMNEAL PHARMS NY | ANDA 078428 | AB | Jul 25, 2007 | |
| GABAPENTIN×3 | WATSON LABS | ANDA 075485 | — | May 11, 2007 | |
| GABAPENTIN×3 | APOTEX | ANDA 077894 | — | Oct 10, 2006 | |
| GABAPENTIN×2 | RUBICON RESEARCH | ANDA 077661 | AB1 | Sep 13, 2006 | |
| GABAPENTIN×3 | SUN PHARM INDS LTD | ANDA 077242 | — | Aug 24, 2006 | |
| GABAPENTIN×2 | SUN PHARM INDS LTD | ANDA 077525 | — | Aug 24, 2006 | |
| GABAPENTIN×2 | GLENMARK PHARMS LTD | ANDA 077662 | AB1 | Aug 18, 2006 | |
| GABAPENTIN×2 | SENORES PHARMS | ANDA 076877 | — | Jul 06, 2006 | |
| GABAPENTIN×2 | CHARTWELL RX | ANDA 076120 | — | Jan 27, 2006 | |
| GABAPENTIN×3 | SANDOZ | ANDA 075428 | — | Jan 24, 2006 | |
| GABAPENTIN×3 | SUN PHARM INDS LTD | ANDA 076606 | — | Oct 07, 2005 | |
| GABAPENTIN×2 | RANBAXY | ANDA 076605 | — | Sep 14, 2005 | |
| GABAPENTIN×3 | SUN PHARM INDUSTRIES | ANDA 076537 | — | Jun 30, 2005 | |
| GABAPENTIN×3 | GRANULES | ANDA 075360 | AB | Apr 06, 2005 | |
| GABAPENTIN×3 | SANDOZ | ANDA 075539 | — | Apr 06, 2005 | |
| GABAPENTIN×3 | CSPC OUYI | ANDA 075477 | AB | Mar 23, 2005 | |
| GABAPENTIN×2 | TEVA | ANDA 075827 | — | Dec 15, 2004 | |
| GABAPENTIN×2 | ACTAVIS ELIZABETH | ANDA 075694 | — | Oct 21, 2004 | |
| GABAPENTIN×3 | TEVA PHARMS | ANDA 075435 | — | Oct 08, 2004 | |
| GABAPENTIN×5 | IVAX SUB TEVA PHARMS | ANDA 076017 | AB1 | Apr 28, 2004 | |
| GABAPENTIN×3 | ACTAVIS ELIZABETH | ANDA 075350 | AB | Sep 12, 2003 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Gabapentin — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
