Divalproex Sodium

Treats manic episodes associated with bipolar disorder Monotherapy and adjunctive therapy…. Sold as Depakote, Depakote Cp, Depakote Er. Every FDA application for this active ingredient: 6 branded and 38 generic.

As of Nov 14, 2026, FDA lists 44 applications for Divalproex Sodium (sold as Depakote, Depakote Cp, Depakote Er), first approved Mar 10, 1983, with 8 new uses approved and 0 published complete response letters.

First approved: Mar 10, 1983
Applications: 44
New uses approved: 8
Complete response letters: 0
Medicare spending, 2025: $245M

Medicare Spending

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


Divalproex Sodium	Part D	$134M	+2%	459,920
Divalproex Sodium ER	Part D	$87.0M	+2%	231,083
Depakote	Part D	$11.3M	-5%	2,200
Depakote ER	Part D	$9.5M	+4%	2,023
Depakote Sprinkle	Part D	$4.0M	+4%	1,122

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

DIVALPROEX DR 125 MG CAP SPRNK: $0.197 per unitGeneric · -10% in a year
DEPAKOTE DR 125 MG SPRINKLE CP: $1.97 per unitBrand · +5% in a year
DEPAKOTE DR 125 MG TABLET: $2.06 per unitBrand · +5% in a year
DEPAKOTE DR 250 MG TABLET: $4.04 per unitBrand · +5% in a year
DEPAKOTE DR 500 MG TABLET: $7.46 per unitBrand · +5% in a year
DEPAKOTE ER 250 MG TABLET: $3.68 per unitBrand · +5% in a year
DEPAKOTE ER 500 MG TABLET: $6.49 per unitBrand · +5% in a year

Clinical Trials

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


CS1 Added to Standard of Care Therapy for Pulmonary Arterial HypertensionPulmonary Arterial Hypertension · Cereno Scientific AB	Phase 2	Not yet recruiting	Aug 12, 2026
Evaluation of Intravenous Sodium Valproate on Interleukin-6 Levels in Patients With TMJ Disc DisplacementTemporomandibular Joint Internal Derangement (ADWR) · Tanta University	Phase 2	Active, not recruiting	Mar 23, 2026
Valproic AcId for Traumatic BRAin INjury TrialModerate Traumatic Brain Injury (TBI), Severe Traumatic Brain Injury · Northwestern University	Phase 2 / Phase 3	Not yet recruiting	Sep 10, 2025
Pharmacogenetics-Based Study on Individualized Use of Sodium ValproateEpilepsy · The First Affiliated Hospital of University of South China	Phase 4	Recruiting	Jul 1, 2025
Efficacy of Hydroxyzine for Patients With Panic DisorderPanic Disorder · Sultan Qaboos University	Phase 4	Not yet recruiting	Feb 21, 2023
Combining Sodium Valproate With Standard-of-care EGFR (Epidermal Growth Factor Receptor) Monoclonal Antibody Treatment in Patients With Metastatic Colorectal CancerMetastatic Colorectal Cancer · Australasian Gastro-Intestinal Trials Group	Phase 2	Active, not recruiting	Jan 23, 2023
Sunitinib Malate or Valproic Acid in Preventing Metastasis in Patients With High-Risk Uveal MelanomaCiliary Body and Choroid Melanoma, Medium/Large Size, Ciliary Body and Choroid Melanoma, Small Size · Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University	Phase 2	Active, not recruiting	Feb 21, 2014

Applications

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


Mar 10, 1983	DepakoteNDA 18723 · New dosage form	Abbvie	56	Marketed
Sep 12, 1989	DepakoteNDA 19680 · New dosage form	Abbvie	44	Marketed
Jul 11, 1990	Depakote CpNDA 19794 · New dosage form	Abbott	2	Discontinued
Aug 4, 2000	Depakote ErNDA 21168 · New dosage form	Abbvie	41	Marketed
Dec 20, 2002	Depakote ErNDA 20782 · New dosage form	Abbott	0	Marketed
Mar 24, 2008	Depakote ErNDA 22267 · TYPE 6	Abbvie Inc	1	Marketed
Jul 29, 2008	Divalproex SodiumANDA 76941	Teva	17	Discontinued
Jul 29, 2008	Divalproex SodiumANDA 77615	Apotex	23	Discontinued
Jul 29, 2008	Divalproex SodiumANDA 78182	Upsher Smith Labs	19	Marketed
Jul 29, 2008	Divalproex SodiumANDA 78290	Invatech	0	Marketed
Jul 29, 2008	Divalproex SodiumANDA 78755	Dr Reddys Labs Ltd	2	Marketed
Jul 29, 2008	Divalproex SodiumANDA 78790	Lupin	22	Discontinued
Jul 29, 2008	Divalproex SodiumANDA 78597	Sun Pharm Inds	20	Marketed
Jul 31, 2008	Divalproex SodiumANDA 77296	Chartwell Rx	10	Marketed
Nov 3, 2008	Divalproex SodiumANDA 78411	Ph Health	1	Discontinued
Nov 25, 2008	Divalproex SodiumANDA 78853	Orbion Pharms	13	Marketed
Jan 23, 2009	Divalproex SodiumANDA 78979	Dr Reddys Labs Ltd	25	Marketed
Jan 27, 2009	Divalproex SodiumANDA 78919	Zydus Pharms USA Inc	19	Marketed
Jan 29, 2009	Divalproex SodiumANDA 77567	Mylan	21	Marketed
Feb 10, 2009	Divalproex SodiumANDA 78705	Sciegen Pharms	6	Marketed
Feb 26, 2009	Divalproex SodiumANDA 78445	Ph Health	10	Discontinued
Feb 27, 2009	Divalproex SodiumANDA 78239	Zydus Pharms USA Inc	24	Marketed
Mar 5, 2009	Divalproex SodiumANDA 77100	Zydus Pharms USA Inc	16	Marketed
Mar 17, 2009	Divalproex SodiumANDA 90062	Pharmobedient	14	Discontinued
May 6, 2009	Divalproex SodiumANDA 78791	Impax Labs	14	Discontinued
Aug 3, 2009	Divalproex SodiumANDA 78700	Cosette Pharms Nc	4	Discontinued
Nov 30, 2009	Divalproex SodiumANDA 90210	Prinston	6	Marketed
Feb 25, 2011	Divalproex SodiumANDA 79080	Actavis Labs Fl Inc	8	Discontinued
Mar 28, 2011	Divalproex SodiumANDA 90407	Rising	13	Discontinued
Apr 5, 2011	Divalproex SodiumANDA 79163	Unichem Labs Ltd	17	Marketed
Apr 21, 2011	Divalproex SodiumANDA 90554	Aurobindo Pharma Ltd	21	Marketed
Mar 12, 2012	Divalproex SodiumANDA 90070	Reddys	21	Marketed
Mar 15, 2012	Divalproex SodiumANDA 90161	Dr Reddys Labs Ltd	21	Marketed
Jun 2, 2014	Divalproex SodiumANDA 202419	Aurobindo Pharma Ltd	21	Marketed
May 29, 2015	Divalproex SodiumANDA 203730	Amneal Pharms	4	Marketed
Oct 18, 2019	Divalproex SodiumANDA 209286	Lupin	8	Marketed
Feb 28, 2020	Divalproex SodiumANDA 213181	Ajanta Pharma Ltd	7	Marketed
Nov 17, 2020	Divalproex SodiumANDA 211505	Teva Pharms USA	0	Discontinued
Mar 15, 2021	Divalproex SodiumANDA 214462	Yichang Humanwell	4	Discontinued
Feb 25, 2022	Divalproex SodiumANDA 214643	Unichem	5	Marketed
Sep 26, 2023	Divalproex SodiumANDA 215527	Annora Pharma	2	Marketed
Dec 19, 2024	Divalproex SodiumANDA 218793	Alembic	3	Marketed
Aug 12, 2025	Divalproex SodiumANDA 217358	Mankind Pharma	1	Marketed
—	Divalproex SodiumANDA 77254	Mylan	0	Discontinued

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