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NDA

VALPROIC ACID | N018082 | ABBVIE INC

1 strength0 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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

108 trials from ClinicalTrials.gov — 2 recruiting, 1 active, 67 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Sunitinib Malate or Valproic Acid in Preventing Metastasis in Patients With High-Risk Uveal Melanoma NCT02068586	Phase 2	Active	Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University	210	2014-11-19 → 2026-12-31
Metronomic Therapy for Pediatric Patients With Solid Tumors at High Risk of Recurrence NCT02446431	Early Phase 1	Recruiting	Miller Children's & Women's Hospital Long Beach	20	2014-07 → 2029-07
Seizure Treatment in Glioma NCT03048084	Phase 4	Recruiting	Leiden University Medical Center	120	2018-02-01 → 2028-07-01
Estetrol (E4)/Drospirenone (DRSP) Drug-drug Interaction (DDI) Study NCT03512860	Phase 1	Completed	Estetra	24	2018-04-12 → 2018-10-08
Lithium and Divalproex for the Treatment of Comorbid Rapid Cycling Bipolar Disorder and Substance Abuse Disorder NCT00194129	Phase 3	Completed	University Hospitals Cleveland Medical Center	31	1997-11 → 2006-09
Valproic Acid and Carnitine in Patients With Spinal Muscular Atrophy NCT00227266	Phase 2	Completed	University of Utah	94	2005-09 → 2007-11
Trial of Valproic Acid in Patients With Progressive Supranuclear Palsy (Depakine)NCT00385710	Phase 2	Completed	Nantes University Hospital	28	2006-11 → 2010-07
Phase II Randomized Study of Early Surgery Vs Multiple Sequential Antiepileptic Drug Therapy for Infantile Spasms Refractory to Standard Treatment NCT00004758	Phase 2	Completed	National Center for Research Resources (NCRR)	30	1993-11
Valproic Acid in Treating Patients With Kaposi's Sarcoma NCT00075777	N/A	Completed	AIDS Malignancy Consortium	19	2005-02 → 2008-02
CARNIVAL Type I: Valproic Acid and Carnitine in Infants With Spinal Muscular Atrophy (SMA) Type I NCT00661453	Phase 1/2	Completed	University of Utah	40	2008-04 → 2012-06

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

API Supply Chain10 active DMFs11 inactive

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

PCASVALPROIC ACID

DMF 56781985

KATWIJK CHEMIE BVVALPROIC ACID

DMF 64281986

THE NIPPON SYNTHETIC CHEMICAL INDUSTRY CO LTDVALPROIC ACID

DMF 73801988

SCI PHARMTECH INCVALPROIC ACID

DMF 165582003

ANJAN DRUG PRIVATE LTDVALPROIC ACID USP

DMF 200342006

SUN PHARMACEUTICAL INDUSTRIES LTDVALPROIC ACID USP

DMF 214102008

SUN PHARMACEUTICAL INDUSTRIES LTDVALPROIC ACID USP (PROCESS-II)

DMF 357442021

AREVA SYNTHETICS LLCVALPROIC ACID USP

DMF 421782025

HEBEI CHENGUANG TONGSHENG PHARMA CO LTDVALPROIC ACID

DMF 428132025

EMNAR PHARMA PRIVATE LTDVALPROIC ACID

DMF 437022026

DUPONT NUTRITION BIOSCIENCES APSInactiveVALPROIC ACID

DMF 30611977

SYNTEX USA INCInactiveVALPROIC ACID

DMF 32111978

YODOGAWA PHARMACEUTICAL CO LTDInactiveVALPROIC ACID

DMF 33221978

PROCOS SPAInactiveVALPROIC ACID

DMF 43801981

ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIVInactiveVALPROIC ACID

DMF 46571982

SIEGFRIED AGInactiveVALPROIC ACID & SODIUM VALPROATE

DMF 60151985

LIANYUNGANG PHARMACEUTICAL FACTORYInactiveVALPROIC ACID

DMF 96661992

SIEGFRIED CHEMICALS INCInactiveVALPROIC ACID

DMF 131611998

SIEGFRIED CHEMICALS INCInactiveVALPROIC ACID USP

DMF 146071999

SIGNA SA DE CVInactiveVALPROIC ACID USP

DMF 172242004

CALYX CHEMICALS AND PHARMACEUTICALS LTDInactiveVALPROIC ACID

DMF 219702008

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

Approval Letters

25 letters from Drugs@FDA

Date	Submission	Document
May 20, 2020	SUPPL -54	View Letter (PDF)
Nov 26, 2019	SUPPL -53	View Letter (PDF)
Feb 22, 2019	SUPPL -52	View Letter (PDF)
May 10, 2018	SUPPL -51	View Letter (PDF)
Oct 6, 2017	SUPPL -50	View Letter (PDF)
Mar 8, 2017	SUPPL -49	View Letter (PDF)
Nov 4, 2016	SUPPL -48	View Letter (PDF)
Feb 23, 2016	SUPPL -47	View Letter (PDF)
Sep 25, 2015	SUPPL -46	View Letter (PDF)
Mar 17, 2015	SUPPL -45	View Letter (PDF)
Jan 8, 2015	SUPPL -42	View Letter (PDF)
Nov 24, 2014	SUPPL -41	View Letter (PDF)
Aug 21, 2014	SUPPL -44	View Letter (PDF)
Jun 23, 2014	SUPPL -34	View Letter (PDF)
Jun 11, 2014	SUPPL -43	View Letter (PDF)
Sep 17, 2013	SUPPL -39	View Letter (PDF)
Mar 1, 2013	SUPPL -38	View Letter (PDF)
Oct 13, 2011	SUPPL -33	View Letter (PDF)
Oct 13, 2011	SUPPL -31	View Letter (PDF)
Oct 13, 2011	SUPPL -35	View Letter (PDF)
Oct 13, 2011	SUPPL -37	View Letter (PDF)
May 1, 2009	SUPPL -32	View Letter (PDF)
Oct 23, 2006	SUPPL -27	View Letter (PDF)
Jan 20, 2006	SUPPL -26	View Letter (PDF)
Jun 2, 2004	SUPPL -24	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SYRUP;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.