Valproate sodium - Generic Drug Details

What are the generic drug sources for valproate sodium and what is the scope of patent protection?

Valproate sodium is the generic ingredient in two branded drugs marketed by Abbvie, Fresenius Kabi Usa, Hikma Farmaceutica, Norvium Bioscience, and Sagent, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

Three suppliers are listed for this compound.

Summary for valproate sodium

US Patents:	0
Tradenames:	2
Applicants:	5
NDAs:	5
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	112
Clinical Trials:	63
Patent Applications:	6,753
What excipients (inactive ingredients) are in valproate sodium?	valproate sodium excipients list
DailyMed Link:	valproate sodium at DailyMed

Recent Clinical Trials for valproate sodium

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of North Carolina, Chapel Hill	Phase 4
Assiut University	Phase 4
Asian Pharmaceuticals Pvt. Ltd.	Phase 4

See all valproate sodium clinical trials

Pharmacology for valproate sodium

Drug Class	Anti-epileptic Agent Mood Stabilizer
Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

US Patents and Regulatory Information for valproate sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Norvium Bioscience	VALPROATE SODIUM	valproate sodium	INJECTABLE;INJECTION	208120-001	Dec 22, 2021		DISCN	No	No
Fresenius Kabi Usa	VALPROATE SODIUM	valproate sodium	INJECTABLE;INJECTION	076539-001	Jun 26, 2003	AP	RX	No	No
Hikma Farmaceutica	VALPROATE SODIUM	valproate sodium	INJECTABLE;INJECTION	078523-001	Feb 17, 2010	AP	RX	No	Yes
Abbvie	DEPACON	valproate sodium	INJECTABLE;INJECTION	020593-001	Dec 30, 1996		DISCN	Yes	No
Sagent	VALPROATE SODIUM	valproate sodium	INJECTABLE;INJECTION	076295-001	Nov 14, 2002	AP	RX	No	No