Divalproex sodium - Generic Drug Details

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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, Rising, Teva Pharms Usa, Zydus Pharms Usa Inc, Abbott, Actavis Labs Fl Inc, Apotex, Aurobindo Pharma Ltd, Chartwell Rx, Endo Operations, Invatech, Lupin, Mylan, Norvium Bioscience, Orbion Pharms, Prinston Inc, Sun Pharm Inds, Teva, Unichem Labs Ltd, Upsher Smith Labs, Amneal Pharms, Annora Pharma, Cosette, Impax Labs, Lupin Ltd, Reddys, Unichem, Utopic Pharms, and Wockhardt, and is included in forty NDAs. Additional information is available in the individual branded drug profile pages.

There are eighteen drug master file entries for divalproex sodium. Forty-one suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for divalproex sodium

US Patents:	0
Tradenames:	4
Applicants:	31
NDAs:	40
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	41
Raw Ingredient (Bulk) Api Vendors:	53
Clinical Trials:	68
Patent Applications:	7,028
Drug Prices:	Drug price trends 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

Drug Sales Revenue Trends for divalproex sodium

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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

Generic filers with tentative approvals for DIVALPROEX SODIUM

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE;ORAL
⤷ Sign Up	⤷ Sign Up	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE;ORAL
⤷ Sign Up	⤷ Sign Up	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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

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Glossary

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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
Abbott	DEPAKOTE CP	divalproex sodium	TABLET, DELAYED RELEASE;ORAL	019794-001	Jul 11, 1990		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan	DIVALPROEX SODIUM	divalproex sodium	TABLET, EXTENDED RELEASE;ORAL	077567-002	Jan 29, 2009	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Prinston Inc	DIVALPROEX SODIUM	divalproex sodium	TABLET, DELAYED RELEASE;ORAL	090210-003	Nov 30, 2009	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Prinston Inc	DIVALPROEX SODIUM	divalproex sodium	TABLET, DELAYED RELEASE;ORAL	090210-002	Nov 30, 2009	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Upsher Smith Labs	DIVALPROEX SODIUM	divalproex sodium	TABLET, DELAYED RELEASE;ORAL	078182-002	Jul 29, 2008	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abbvie	DEPAKOTE	divalproex sodium	TABLET, DELAYED RELEASE;ORAL	018723-002	Mar 10, 1983	AB	RX	Yes	Yes	⤷ 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

Expired US Patents for divalproex sodium

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	DEPAKOTE ER	divalproex sodium	TABLET, EXTENDED RELEASE;ORAL	021168-002	May 31, 2002	⤷ Sign Up	⤷ Sign Up
Abbvie	DEPAKOTE ER	divalproex sodium	TABLET, EXTENDED RELEASE;ORAL	021168-002	May 31, 2002	⤷ Sign Up	⤷ Sign Up
Abbott	DEPAKOTE CP	divalproex sodium	TABLET, DELAYED RELEASE;ORAL	019794-002	Jul 11, 1990	⤷ Sign Up	⤷ Sign Up
Abbvie	DEPAKOTE	divalproex sodium	CAPSULE, DELAYED REL PELLETS;ORAL	019680-001	Sep 12, 1989	⤷ Sign Up	⤷ Sign Up
Abbvie	DEPAKOTE ER	divalproex sodium	TABLET, EXTENDED RELEASE;ORAL	021168-001	Aug 4, 2000	⤷ Sign Up	⤷ Sign Up
Abbvie	DEPAKOTE ER	divalproex sodium	TABLET, EXTENDED RELEASE;ORAL	021168-002	May 31, 2002	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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