Gabapentin

Manages postherpetic neuralgia. Sold as Neurontin, Gralise. Every FDA application for this active ingredient: 8 branded and 70 generic.

As of Nov 14, 2026, FDA lists 78 applications for Gabapentin (sold as Neurontin, Gralise), first approved Dec 30, 1993, with 7 new uses approved and 0 published complete response letters.

First approved: Dec 30, 1993
Applications: 78
New uses approved: 7
Complete response letters: 0
Medicare spending, 2025: $606M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Gabapentin	Part D	$565M	+4%	8,136,131
Neurontin	Part D	$17.5M	-6%	2,258
Gabarone	Part D	$11.6M	New	2,434
Gralise	Part D	$7.7M	-39%	1,484
Gabapentin ER	Part D	$4.4M	+15%	3,638

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

GABAPENTIN 100 MG CAPSULE: $0.022 per unitGeneric · +4% in a year
GABAPENTIN 250 MG/5 ML SOLN: $0.084 per MLGeneric · -3% in a year
GABAPENTIN 300 MG CAPSULE: $0.033 per unitGeneric · -3% in a year
GABAPENTIN 400 MG CAPSULE: $0.043 per unitGeneric · +3% in a year
GABAPENTIN 600 MG TABLET: $0.064 per unitGeneric · -10% in a year
GABAPENTIN 800 MG TABLET: $0.086 per unitGeneric · -15% in a year
GABAPENTIN ER 300 MG TABLET: $0.623 per unitGeneric · -61% in a year
GABAPENTIN ER 600 MG TABLET: $1.11 per unitGeneric · -41% in a year
NEURONTIN 100 MG CAPSULE: $2.96 per unitBrand · +5% in a year
NEURONTIN 300 MG CAPSULE: $7.36 per unitBrand · +5% in a year
NEURONTIN 400 MG CAPSULE: $8.87 per unitBrand · +5% in a year
NEURONTIN 600 MG TABLET: $14.11 per unitBrand · +5% in a year

Orphan Designations (FDA)

2 designations, 1 approved for the designated use; see all orphan designations

Management of postherpetic neuralgiaGolf Acquiror LLC · designated Nov 8, 2010 · approved Jan 28, 2011
Treatment of amyotrophic lateral sclerosisWarner-Lambert Company · designated Jul 5, 1995

Clinical Trials

69 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Physical Therapy for the Management of Postoperative Pain After Minimally Invasive Thoracic SurgeryPost Operative Pain · University of Miami	Phase 4	Not yet recruiting	Nov 12, 2026
Oral Gabapentin Versus Intravenous Neostigmine/Atropine Versus Combination of Both for Prevention of PDPHPostdural Puncture Headache (PDPH) · Assiut University	Phase 2 / Phase 3	Recruiting	Nov 4, 2026
Suzetrigine for Analgesiain Arthroscopic Rotator Cuff RepairArtroscopic Surgery, Pain Management · University of Alabama at Birmingham	Phase 4	Not yet recruiting	Oct 8, 2026
Gabapentin vs. Benzonatate vs. Standard of Care for Cough in ILDInterstitial Lung Disease · Post Graduate Institute of Medical Education and Research, Chandigarh	Phase 4	Not yet recruiting	Oct 6, 2026
Mechanistic Evaluation of Polypharmacy Effects for PainChronic Lower Back Pain (CLBP) · University of Maryland, Baltimore	Phase 1 / Phase 2	Not yet recruiting	Sep 29, 2026
Epidural Analgesia Versus Opioid-sparing Analgesia for Open Ventral Hernia Repair With Transversus Abdominis ReleaseVentral Hernia, Ventral Hernia Repair · Northwestern University	Phase 4	Recruiting	Sep 24, 2026
Abuse Potential of Gabapentin Taken Orally Concomitantly With Oxycodone Hydrochloride in Healthy, Non-Drug-Dependent, Recreational Opioid UsersHealthy · Viatris Inc.	Phase 4	Recruiting	Sep 10, 2026
Modality Choice Before and After Failure for the Treatment of Painful Diabetic NeuropathyPainful Diabetic Neuropathy (PDN), Diabetic Nephropathies · University of Michigan	Phase 4	Not yet recruiting	Aug 31, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Dec 30, 1993	NeurontinNDA 20235 · New molecular entity	Viatris	37	Marketed
Oct 9, 1998	NeurontinNDA 20882 · New dosage form	Viatris	26	Marketed
Mar 2, 2000	NeurontinNDA 21129 · New dosage form	Viatris	28	Marketed
Oct 12, 2000	NeurontinNDA 21216 · TYPE 6	Parke Davis	1	Marketed
May 24, 2002	NeurontinNDA 21424 · TYPE 6	Parke Davis	0	Marketed
May 24, 2002	NeurontinNDA 21397 · TYPE 6	Parke Davis	0	Marketed
May 24, 2002	NeurontinNDA 21423 · TYPE 6	Parke Davis	0	Marketed
Sep 12, 2003	GabapentinANDA 75350	Actavis Elizabeth	17	Marketed
Apr 28, 2004	GabapentinANDA 76017	Ivax Sub Teva Pharms	17	Marketed
Oct 8, 2004	GabapentinANDA 75435	Teva Pharms	11	Discontinued
Oct 21, 2004	GabapentinANDA 75694	Actavis Elizabeth	17	Discontinued
Dec 15, 2004	GabapentinANDA 75827	Teva	4	Discontinued
Mar 23, 2005	GabapentinANDA 75477	Cspc Ouyi	5	Marketed
Apr 6, 2005	GabapentinANDA 75539	Sandoz	7	Discontinued
Apr 6, 2005	GabapentinANDA 75360	Granules	15	Marketed
Jun 30, 2005	GabapentinANDA 76537	Sun Pharm Industries	1	Discontinued
Sep 14, 2005	GabapentinANDA 76605	Ranbaxy	0	Discontinued
Oct 7, 2005	GabapentinANDA 76606	Sun Pharm Inds Ltd	3	Discontinued
Jan 24, 2006	GabapentinANDA 75428	Sandoz	4	Discontinued
Jan 27, 2006	GabapentinANDA 76120	Chartwell Rx	2	Discontinued
Jul 6, 2006	GabapentinANDA 76877	Pharmazone	1	Discontinued
Aug 18, 2006	GabapentinANDA 77662	Glenmark Pharms Ltd	14	Marketed
Aug 24, 2006	GabapentinANDA 77525	Sun Pharm Inds Ltd	10	Discontinued
Aug 24, 2006	GabapentinANDA 77242	Sun Pharm Inds Ltd	13	Discontinued
Sep 13, 2006	GabapentinANDA 77661	Rubicon Research	14	Marketed
Oct 10, 2006	GabapentinANDA 77894	Apotex	11	Discontinued
May 11, 2007	GabapentinANDA 75485	Watson Labs	1	Discontinued
Jul 25, 2007	GabapentinANDA 78428	Amneal Pharms Ny	20	Marketed
Sep 25, 2007	GabapentinANDA 78150	Hikma	10	Discontinued
Jan 31, 2008	GabapentinANDA 78787	Aurobindo Pharma	16	Marketed
Dec 30, 2009	GabapentinANDA 90705	Invagen Pharms	13	Marketed
Jun 1, 2010	GabapentinANDA 90335	Pharmobedient	9	Discontinued
Dec 17, 2010	GabapentinANDA 90858	Alkem	12	Marketed
Jan 28, 2011	GraliseNDA 22544 · New dosage form	Almatica	20	Marketed
Feb 11, 2011	GabapentinANDA 78926	Zydus Pharms USA Inc	12	Marketed
Feb 14, 2011	GabapentinANDA 90158	Pharmazone	8	Discontinued
Feb 18, 2011	GabapentinANDA 78974	Mission Pharmacal	6	Marketed
Jul 21, 2011	GabapentinANDA 78782	Hikma Pharms	5	Discontinued
Jul 21, 2011	GabapentinANDA 90007	Pharmazone	9	Marketed
Oct 6, 2011	GabapentinANDA 200651	Aurobindo Pharma Ltd	11	Marketed
Mar 23, 2012	GabapentinANDA 202024	Amneal Pharms	10	Marketed
May 1, 2012	GabapentinANDA 76403	Acella Pharms LLC	1	Marketed
Oct 16, 2012	GabapentinANDA 202764	Invagen Pharms	7	Discontinued
Jul 3, 2013	GabapentinANDA 76672	Taro	0	Discontinued
Jul 12, 2013	GabapentinANDA 203244	Strides Pharma	9	Marketed
Aug 2, 2013	GabapentinANDA 77261	Taro	0	Discontinued
Dec 23, 2015	GabapentinANDA 206402	Alkem Labs Ltd	8	Marketed
Feb 4, 2016	GabapentinANDA 205101	Sciegen Pharms	10	Marketed
Feb 18, 2016	RelgaabiANDA 204989	Sciegen Pharms	9	Marketed
Mar 14, 2016	GabapentinANDA 91286	Ajenat Pharms	3	Marketed
Mar 10, 2017	GabapentinANDA 205807	Teva Pharms USA	2	Discontinued
Mar 24, 2017	GabapentinANDA 207099	Rising	5	Marketed
Oct 26, 2017	GabapentinANDA 91008	Chartwell Rx	0	Discontinued
Oct 26, 2017	GabapentinANDA 207057	Cspc Ouyi	4	Marketed
May 14, 2018	GabapentinANDA 206943	Strides Pharma	6	Marketed
Aug 24, 2018	GabapentinANDA 209306	Lupin	3	Discontinued
Oct 16, 2018	GabapentinANDA 211314	Strides Pharma	5	Marketed
Dec 3, 2019	GabapentinANDA 211330	Pai Holdings Pharm	5	Marketed
Aug 17, 2020	GabapentinANDA 213603	Zhejiang Yongtai	3	Marketed
May 10, 2021	GabapentinANDA 214956	Ascent Pharms Inc	2	Marketed
Oct 1, 2021	GabapentinANDA 214957	Ascent Pharms Inc	2	Marketed
Jan 18, 2023	GabapentinANDA 216492	Rubicon Research	1	Marketed
Mar 28, 2023	GabapentinANDA 217116	Granules	2	Marketed
May 12, 2023	GabapentinANDA 217546	Pharmobedient	3	Marketed
Jul 19, 2023	GabapentinANDA 217995	Rising	2	Marketed
Nov 20, 2023	GabapentinANDA 208928	Ipca Labs Ltd	2	Discontinued
Jan 17, 2024	GabapentinANDA 217682	Annora Pharma	2	Marketed
Jan 24, 2024	GabapentinANDA 203934	Zydus Pharms	1	Marketed
Feb 26, 2024	GabapentinANDA 216252	Epic Pharma LLC	2	Marketed
Feb 26, 2024	GabapentinANDA 218075	Annora Pharma	1	Marketed
Mar 4, 2024	GabapentinANDA 211313	Strides Pharma	2	Marketed
Apr 8, 2024	GabapentinANDA 217965	Pharmobedient	3	Marketed
May 29, 2024	GabapentinANDA 209855	Ipca Labs Ltd	2	Discontinued
Sep 9, 2024	GabapentinANDA 203643	Abon Pharms LLC	0	Marketed
Aug 7, 2025	GabapentinANDA 219319	Pharmazone	1	Marketed
Sep 19, 2025	GabapentinANDA 218491	Sciegen Pharms	0	Marketed
Mar 6, 2026	GabapentinANDA 219814	Prinston	0	Marketed
Jun 23, 2026	GabapentinANDA 203611	Actavis Elizabeth	0	Marketed

Show all 78

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA