Valproic acid - Generic Drug Details

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What are the generic drug sources for valproic acid and what is the scope of freedom to operate?

Valproic acid is the generic ingredient in three branded drugs marketed by Bionpharma, Abbvie, Catalent, Hibrow Hlthcare, Par Pharm, Scherer Rp, Sun Pharm Inds Ltd, Upsher Smith Labs, Ani Pharms, Chartwell Rx, Hikma, Lannett Co Inc, Nostrum Labs Inc, Pharm Assoc, Pharmobedient Cnsltg, and Quagen, and is included in eighteen NDAs. Additional information is available in the individual branded drug profile pages.

There are seventeen drug master file entries for valproic acid. Seventeen suppliers are listed for this compound.

Sponsor	Phase
Sohag University	Phase 2/Phase 3
Dr Cipto Mangunkusumo General Hospital	Phase 4
Wayne State University	Phase 4

Sponsor

Phase

Sohag University

Phase 2/Phase 3

Dr Cipto Mangunkusumo General Hospital

Phase 4

Wayne State University

Phase 4

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ani Pharms	VALPROIC ACID	valproic acid	SYRUP;ORAL	073178-001	Aug 25, 1992	AA	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abbvie	DEPAKENE	valproic acid	SYRUP;ORAL	018082-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	VALPROIC ACID	valproic acid	SYRUP;ORAL	074060-001	Jan 13, 1995		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Lannett Co Inc	VALPROIC ACID	valproic acid	SYRUP;ORAL	077960-001	Oct 13, 2006		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

US Patents:	0
Tradenames:	3
Applicants:	16
NDAs:	18
Drug Master File Entries:	17
Finished Product Suppliers / Packagers:	17
Raw Ingredient (Bulk) Api Vendors:	144
Clinical Trials:	189
Patent Applications:	7,080
Drug Prices:	Drug price trends for valproic acid
What excipients (inactive ingredients) are in valproic acid?	valproic acid excipients list
DailyMed Link:	valproic acid at DailyMed

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