See also: Generic Depakote
Depakote ER is a brand name of divalproex sodium, approved by the FDA in the following formulation(s):
DEPAKOTE ER (divalproex sodium - tablet, extended release; oral)
Manufacturer: ABBOTT
Approval date: August 4, 2000
Strength(s): EQ 500MG VALPROIC ACID [RLD][AB]
Manufacturer: ABBOTT
Approval date: May 31, 2002
Strength(s): EQ 250MG VALPROIC ACID [AB]
Has a generic version of Depakote ER been approved?
A generic version of Depakote ER has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Depakote ER and have been approved by the FDA:
divalproex sodium tablet, extended release; oral
Manufacturer: ANCHEN PHARMS
Approval date: February 26, 2009
Strength(s): EQ 250MG VALPROIC ACID [AB]
Manufacturer: ANCHEN PHARMS
Approval date: August 4, 2009
Strength(s): EQ 500MG VALPROIC ACID [AB]
Manufacturer: IMPAX LABS
Approval date: May 6, 2009
Strength(s): EQ 250MG VALPROIC ACID [AB]
Manufacturer: IMPAX LABS
Approval date: August 4, 2009
Strength(s): EQ 500MG VALPROIC ACID [AB]
Manufacturer: MYLAN
Approval date: January 29, 2009
Strength(s): EQ 250MG VALPROIC ACID [AB], EQ 500MG VALPROIC ACID [AB]
Manufacturer: TEVA PHARMS
Approval date: August 3, 2009
Strength(s): EQ 500MG VALPROIC ACID [AB]
Manufacturer: WOCKHARDT
Approval date: February 10, 2009
Strength(s): EQ 250MG VALPROIC ACID [AB]
Manufacturer: WOCKHARDT
Approval date: August 4, 2009
Strength(s): EQ 500MG VALPROIC ACID [AB]
Manufacturer: ZYDUS PHARMS USA INC
Approval date: February 27, 2009
Strength(s): EQ 250MG VALPROIC ACID [AB]
Manufacturer: ZYDUS PHARMS USA INC
Approval date: August 4, 2009
Strength(s): EQ 500MG VALPROIC ACID [AB]
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Depakote ER. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: About generic drugs.
Related Patents
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
Controlled release formulation of divalproex sodium
Patent 6,419,953
Issued: July 16, 2002
Inventor(s): Yihong; Qiu & Paul Richard; Poska & Howard S.; Cheskin & J. Daniel; Bollinger & Robert K.; Engh
Assignee(s): Abbott Laboratories
The present invention pertains to a hydrophilic matrix tablet suitable for the once-a-day administration of valproate compounds such as divalproex sodium. The tablet comprises from about 50 weight percent to about 55 weight percent of an active ingredient selected from the group consisting of valproic acid, a pharmaceutically acceptable salt or ester of valproic acid, divalproex sodium, and valpromide; from about 20 weight percent to about 40 weight percent hydroxypropyl methylcellulose; from about 5 weight percent to about 15 weight percent lactose, from about 4 weight percent to about 6 weight percent microcrystalline cellulose, and from about 1 weight percent to about 5 weight percent of silicon dioxide; all weight percentages based upon the total weight of the tablet dosage form. Other aspects of the invention relate to the use of this formulation in the treatment of epilepsy and to methods for manufacturing this dosage form.Patent expiration dates:
- December 18, 2018
- June 18, 2019✓
- December 18, 2018
Controlled release formulation of divalproex sodium
Patent 6,511,678
Issued: January 28, 2003
Inventor(s): Yihong; Qiu & J. Daniel; Bollinger & Sandeep; Dutta & Howard S.; Cheskin & Kevin R.; Engh & Richard P.; Poska
Assignee(s): Abbott Laboratories
A new oral polymeric controlled release formulation suitable for the once-a-day administration of valproate compounds, such as divalproex sodium, has been discovered. This formulation exhibits significant advantages over the sustained release valproate formulations of the prior art. This formulation minimizes the variation between peak and trough plasma levels of valproate over a 24 hour dosing period. This formulation follows a zero-order release pattern thus producing essentially flat plasma levels of valproate, once steady-state levels have been achieved. This results in a significantly lower incidence of side effects for patients consuming such a formulation.Patent expiration dates:
- December 18, 2018
- June 18, 2019✓
- December 18, 2018
Controlled release formulation of divalproex sodium
Patent 6,528,090
Issued: March 4, 2003
Inventor(s): Yihong; Qiu & J. Daniel; Bollinger & Howard S.; Cheskin & Sandeep; Dutta & Kevin R.; Engh & Richard P.; Poska
Assignee(s): Abbott Laboratories
A new oral polymeric controlled release formulation suitable for the once-a-day administration of valproate compounds, such as divalproex sodium, has been discovered. This formulation exhibits significant advantages over the sustained release valproate formulations of the prior art. This formulation minimizes the variation between peak and trough plasma levels of valproate over a 24 hour dosing period. This formulation follows a zero-order release pattern thus producing essentially flat plasma levels of valproate, once steady-state levels have been achieved. This results in a significantly lower incidence of side effects for patients consuming such a formulation.Patent expiration dates:
- December 18, 2018✓
- June 18, 2019✓
- December 18, 2018
Controlled release formulation of divalproex sodium
Patent 6,528,091
Issued: March 4, 2003
Inventor(s): Yihong; Qiu & Paul Richard; Poska & Howard S.; Cheskin & J. Daniel; Bollinger & Robert K.; Engh
Assignee(s): Abbott Laboratories
A controlled release tablet formulation which permits once daily dosing in the treatment of epilepsy comprises from about 50 weight percent to about 55 weight percent of an active ingredient selected from the group consisting of valproic acid, a pharmaceutically acceptable salt or ester of valproic acid, divalproex sodium, and valpromide; from about 20 weight percent to about 40 weight percent hydroxypropyl methylcellulose; from about 5 weight percent to about 15 weight percent lactose, from about 4 weight percent to about 6 weight percent microcrystalline cellulose, and from about 1 weight percent to about 5 weight percent silicon dioxide having an average particle size ranging between about 1 micron and about 10 microns; all weight percentages based upon the total weight of the tablet dosage form. Also disclosed are pre-tableting granular formulations, methods of making the granular formulations and tablets, and a method of treating epilepsy employing the controlled release tablet formulations of the invention.Patent expiration dates:
- December 18, 2018✓
- June 18, 2019✓
- December 18, 2018
Controlled release formulation of divalproex sodium
Patent 6,713,086
Issued: March 30, 2004
Inventor(s): Yihong; Qiu & J. Daniel; Bollinger & Howard S.; Cheskin & Sandeep; Dutta & Kevin R.; Engh & Richard P.; Poska
Assignee(s): Abbott Laboratories
A new oral polymeric controlled release formulation suitable for the once-a-day administration of valproate compounds, such as divalproex sodium, has been discovered. This formulation exhibits significant advantages over the sustained release valproate formulations of the prior art. This formulation minimizes the variation between peak and trough plasma levels of valproate over a 24 hour dosing period. This formulation follows a zero-order release pattern thus producing essentially flat plasma levels of valproate, once steady-state levels have been achieved. This results in a significantly lower incidence of side effects for patients consuming such a formulation.Patent expiration dates:
- December 18, 2018✓✓
- June 18, 2019✓
- December 18, 2018
Controlled release formulation of divalproex sodium
Patent 6,720,004
Issued: April 13, 2004
Inventor(s): Yihong; Qiu & J. Daniel; Bollinger & Sandeep; Dutta & Howard S.; Cheskin & Kevin R.; Engh & Richard P.; Poska
Assignee(s): Abbott Laboratories
A new oral polymeric controlled release formulation suitable for the once-a-day administration of valproate compounds, such as divalproex sodium, has been discovered. This formulation exhibits significant advantages over the sustained release valproate formulations of the prior art. This formulation minimizes the variation between peak and trough plasma levels of valproate over a 24 hour dosing period. This formulation follows a zero-order release pattern thus producing essentially flat plasma levels of valproate, once steady-state levels have been achieved. This results in a significantly lower incidence of side effects for patients consuming such a formulation.Patent expiration dates:
- December 18, 2018✓
- June 18, 2019✓
- December 18, 2018
Related Exclusivities
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.
- Exclusivity expiration dates:
- March 24, 2011 - EXPANDED INFORMATION TO PEDIATRIC USE SUBSECTION OF LABELING IN RESPONSE TO PEDIATRIC WRITTEN REQUEST
- September 24, 2011 - PEDIATRIC EXCLUSIVITY
See also...
- Depakote ER Extended-Release Tablets Consumer Information (Wolters Kluwer)
- Depakote ER Consumer Information (Cerner Multum)
- Depakote ER Advanced Consumer Information (Micromedex)
- Divalproex Delayed-Release Tablets Consumer Information (Wolters Kluwer)
- Divalproex Extended-Release Tablets Consumer Information (Wolters Kluwer)
- Divalproex Sprinkle Capsules Consumer Information (Wolters Kluwer)
- Divalproex sodium Consumer Information (Cerner Multum)
- Alti-Valproic Advanced Consumer Information (Micromedex)
- Depakote DR Advanced Consumer Information (Micromedex)
- Divalproex sodium Advanced Consumer Information (Micromedex)
No comments:
Post a Comment