Viewing data from:

DEPAKOTE ER

NDA

DIVALPROEX SODIUM | N021168 | ABBVIE INC

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

89 trials from ClinicalTrials.gov, 75 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Bioequivalence Study of Divalproex Sodium Capsules(Sprinkle),125 mg of Dr. Reddy's Under Fasting Condition (Apple Sauce)NCT01132183	Phase 1	Completed	Dr. Reddy's Laboratories Limited	34	2007-02 → 2007-03
Divalproex Sodium ER in Adult Autism NCT00211796	Phase 4	Completed	Montefiore Medical Center	10	2005-04 → 2007-04
Naturalistic Study, Comparison of Divalproex Extended Release (ER) and Quetiapine for Adults With Acute Mania or Mixed Episodes NCT00397020	Phase 4	Completed	University of California, San Diego	30	2006-12 → 2008-12
Fasting Study of Divalproex Sodium Extended-Release Tablets 500 mg to Depakote ER® Tablets 500 mg NCT00647712	Phase 1	Completed	Mylan Pharmaceuticals Inc	38	2004-12 → 2004-12
Risperidone Alone Vs. Risperidone Plus Valproate in the Treatment of Patients With Schizophrenia and Hostility NCT00308360	Phase 4	Completed	Nathan Kline Institute for Psychiatric Research	46	1999-09 → 2004-04
A Comparison of Olanzapine in Combination With a Mood Stabilizer vs Mood Stabilizer Alone, in Mixed Bipolar Patients NCT00402324	Phase 4	Completed	Eli Lilly and Company	202	2006-12 → 2008-02
Bioequivalence Study of Divalproex Sodium 125 MG Delayed Release Tablets Under Fasting Conditions NCT00864006	Phase 1	Completed	Sandoz	28	2006-10 → 2006-10
Drug Treatment for Alcoholics With Bipolar Disorder NCT00000439	Phase 2	Completed	National Institute on Alcohol Abuse and Alcoholism (NIAAA)	72	2000-10 → 2003-08
Treatment of Mania Symptoms With Drug Therapy NCT00183443	Phase 3	Completed	Palo Alto Veterans Institute for Research	75	2005-02 → 2010-11
Divalproex Sodium (Depakote) for Explosive Tempers in Adolescents and Adults NCT00218114	Phase 3	Completed	New York State Psychiatric Institute	25	2000-02 → 2005-02-18

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$6.50

per ea

Lowest NADAC/Unit

$3.68

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00074740213DEPAKOTE ER 500 MG TABLET	$6.50	EA	Brand	$0.1838	2026-06-17
00074740113DEPAKOTE ER 250 MG TABLET	$3.68	EA	Brand	$0.1383	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$262.25

Highest Price

$629.76

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00074-7401-13DEPAKOTE ER 250MG TABLETS	$358.02	FSS	Abbvie US LLC	07/31/2030
00074-7401-13DEPAKOTE ER 250MG TABLETS	$262.25	Big4	Abbvie US LLC	07/31/2030
00074-7402-13DEPAKOTE ER 500MG TAB	$629.76	FSS	Abbvie US LLC	07/31/2030
00074-7402-13DEPAKOTE ER 500MG TAB	$442.67	Big4	Abbvie US LLC	07/31/2030

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Depakote ER (2024)

Total Spending

$9.2M

Total Claims

12,774

Beneficiaries

2,044

Avg Cost/Unit

$3.67

Spending Trend

$19.7M(2019)→$19.0M(2020)→$17.7M(2021)→$16.3M(2022)→$11.1M(2023)→$9.2M(2024)

YoY Change:-18.3%

5yr CAGR:-7.2%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain16 active DMFs5 inactive

14 active API suppliers hold Drug Master Files for this ingredient.

PCASDIVALPROEX SODIUM

DMF 146461999

KATWIJK CHEMIE BVDIVALPROEX SODIUM

DMF 163122002

WOCKHARDT LTDDIVALPROEX SODIUM

DMF 174692004

SCI PHARMTECH INCDIVALPROEX SODIUM

DMF 182852005

SUVEN LIFE SCIENCES LTDDIVALPROEX SODIUM

DMF 192662006

DR REDDYS LABORATORIES LTDDIVALPROEX SODIUM USP

DMF 198712006

SUN PHARMACEUTICAL INDUSTRIES LTDDIVALPROEX SODIUM USP

DMF 198842006

ANJAN DRUG PRIVATE LTDDIVALPROEX SODIUM USP

DMF 200362006

ORBION PHARMACEUTICALS PRIVATE LTDDIVALPROEX SODIUM

DMF 202062007

HARMAN FINOCHEM LTDDIVALPROEX SODIUM USP

DMF 215322008

RAKS PHARMA PVT LTDDIVALPROEX SODIUM USP

DMF 239152010

APITORIA PHARMA PRIVATE LTDDIVALPROEX SODIUM USP

DMF 290972015

HETERO DRUGS LTDDIVALPROEX SODIUM

DMF 314372018

MAITHRI DRUGS PRIVATE LTDDIVALPROEX SODIUM USP

DMF 344402019

SUN PHARMACEUTICAL INDUSTRIES LTDDIVALPROEX SODIUM USP (PROCESS II)

DMF 389112023

APITORIA PHARMA PRIVATE LTDDIVALPROEX SODIUM USP (PROCESS-II)

DMF 418712026

SELOC FRNCEInactiveDIVALPROEX SODIUM

DMF 75531988

CILAG AGInactiveDIVALPROEX SODIUM

DMF 162242002

PROCOS SPAInactiveDIVALPROEX SODIUM

DMF 173492004

CHENG FONG CHEMICAL CO LTDInactiveDIVALPROEX SODIUM

DMF 180642005

GENESEN LABS LTDInactiveDIVALPROEX SODIUM

DMF 213412007

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

39 letters from Drugs@FDA

Date	Submission	Document
Apr 2, 2026	SUPPL -52	View Letter (PDF)
May 5, 2025	SUPPL -49	View Letter (PDF)
Feb 6, 2025	SUPPL -48	View Letter (PDF)
Mar 19, 2024	SUPPL -46	View Letter (PDF)
Feb 27, 2023	SUPPL -44	View Letter (PDF)
Dec 1, 2021	SUPPL -43	View Letter (PDF)
Feb 11, 2021	SUPPL -42	View Letter (PDF)
May 20, 2020	SUPPL -41	View Letter (PDF)
Nov 26, 2019	SUPPL -40	View Letter (PDF)
Feb 22, 2019	SUPPL -39	View Letter (PDF)
May 10, 2018	SUPPL -38	View Letter (PDF)
Oct 6, 2017	SUPPL -37	View Letter (PDF)
Mar 8, 2017	SUPPL -36	View Letter (PDF)
Nov 4, 2016	SUPPL -35	View Letter (PDF)
Feb 23, 2016	SUPPL -33	View Letter (PDF)
Sep 25, 2015	SUPPL -32	View Letter (PDF)
Apr 16, 2015	SUPPL -30	View Letter (PDF)
Mar 17, 2015	SUPPL -31	View Letter (PDF)
Jan 8, 2015	SUPPL -27	View Letter (PDF)
Nov 24, 2014	SUPPL -26	View Letter (PDF)
Aug 21, 2014	SUPPL -29	View Letter (PDF)
Jun 23, 2014	SUPPL -19	View Letter (PDF)
Jun 11, 2014	SUPPL -28	View Letter (PDF)
Sep 17, 2013	SUPPL -24	View Letter (PDF)
Mar 1, 2013	SUPPL -23	View Letter (PDF)
Oct 19, 2011	SUPPL -16	View Letter (PDF)
Oct 19, 2011	SUPPL -17	View Letter (PDF)
Oct 19, 2011	SUPPL -20	View Letter (PDF)
Oct 19, 2011	SUPPL -22	View Letter (PDF)
May 4, 2009	SUPPL -18	View Letter (PDF)
Mar 26, 2008	SUPPL -15	View Letter (PDF)
Oct 23, 2006	SUPPL -14	View Letter (PDF)
Jan 20, 2006	SUPPL -9	View Letter (PDF)
Dec 13, 2005	SUPPL -12	View Letter (PDF)
Jun 15, 2004	SUPPL -7	View Letter (PDF)
Jun 2, 2004	SUPPL -4	View Letter (PDF)
Jun 2, 2004	SUPPL -3	View Letter (PDF)
May 31, 2002	SUPPL -1	View Letter (PDF)
Aug 4, 2000	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 500MG VALPROIC ACID

RLDAB

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Aug 4, 2000

No patent or exclusivity listings for this strength.

#002 — EQ 250MG VALPROIC ACID

RLDAB

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: May 31, 2002