Divalproex sodium - Generic Drug Details

What are the generic sources for divalproex sodium and what is the scope of freedom to operate?

Divalproex sodium is the generic ingredient in four branded drugs marketed by Abbvie, Ajanta Pharma Ltd, Dr Reddys Labs Ltd, Mylan, Teva Pharms Usa, Zydus Pharms Usa Inc, Abbott, Actavis Labs Fl Inc, Anchen Pharms, Apotex, Aurobindo Pharma Ltd, Celltrion, Invatech, Lupin, Orbion Pharms, Prinston Inc, Sun Pharm Inds, Teva, Unichem Labs Ltd, Upsher Smith Labs, Amneal Pharms, Amta, Cosette, Impax Labs, Lupin Ltd, Reddys, Unichem, and Wockhardt, and is included in thirty-nine NDAs. Additional information is available in the individual branded drug profile pages.

There are eighteen drug master file entries for divalproex sodium. Forty-two suppliers are listed for this compound.

Summary for divalproex sodium

US Patents:	0
Tradenames:	4
Applicants:	28
NDAs:	39
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	42
Raw Ingredient (Bulk) Api Vendors:	61
Clinical Trials:	68
Patent Applications:	7,149
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for divalproex sodium
Drug Sales Revenues:	Drug sales revenues for divalproex sodium
What excipients (inactive ingredients) are in divalproex sodium?	divalproex sodium excipients list
DailyMed Link:	divalproex sodium at DailyMed

See drug prices for divalproex sodium

See drug sales revenues for divalproex sodium

Recent Clinical Trials for divalproex sodium

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

Sponsor	Phase
Emalex Biosciences Inc.	Phase 1
Syneos Health	Phase 1
Nuventra	Phase 1

See all divalproex sodium clinical trials

Pharmacology for divalproex sodium

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

Paragraph IV (Patent) Challenges for DIVALPROEX SODIUM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DEPAKOTE ER	Extended-release Tablets	divalproex sodium	500 mg	021168		2005-02-08
DEPAKOTE ER	Extended-release Tablets	divalproex sodium	250 mg	021168		2004-05-03

US Patents and Regulatory Information for divalproex sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Invatech	DIVALPROEX SODIUM	divalproex sodium	TABLET, DELAYED RELEASE;ORAL	078290-002	Jul 29, 2008	AB	RX	No	No
Aurobindo Pharma Ltd	DIVALPROEX SODIUM	divalproex sodium	TABLET, DELAYED RELEASE;ORAL	090554-002	Apr 21, 2011	AB	RX	No	No
Invatech	DIVALPROEX SODIUM	divalproex sodium	TABLET, DELAYED RELEASE;ORAL	078290-003	Jul 29, 2008	AB	RX	No	No
Mylan	DIVALPROEX SODIUM	divalproex sodium	CAPSULE, DELAYED REL PELLETS;ORAL	090407-001	Mar 28, 2011		DISCN	No	No
Celltrion	DIVALPROEX SODIUM	divalproex sodium	TABLET, DELAYED RELEASE;ORAL	077296-002	Jul 31, 2008	AB	RX	No	No

Expired US Patents for divalproex sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	DEPAKOTE ER	divalproex sodium	TABLET, EXTENDED RELEASE;ORAL	021168-001	Aug 4, 2000
Abbvie	DEPAKOTE	divalproex sodium	TABLET, DELAYED RELEASE;ORAL	018723-002	Mar 10, 1983
Abbvie	DEPAKOTE	divalproex sodium	TABLET, DELAYED RELEASE;ORAL	018723-003	Oct 26, 1984
Abbvie	DEPAKOTE ER	divalproex sodium	TABLET, EXTENDED RELEASE;ORAL	021168-001	Aug 4, 2000
Abbvie	DEPAKOTE	divalproex sodium	CAPSULE, DELAYED REL PELLETS;ORAL	019680-001	Sep 12, 1989