Generic Depakote ER Availability

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: ABBVIE
    Approval date: August 4, 2000
    Strength(s): EQ 500MG VALPROIC ACID [RLD] [AB]
  • Manufacturer: ABBVIE
    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: DR REDDYS LABS LTD
    Approval date: March 15, 2012
    Strength(s): EQ 250MG 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: REDDYS
    Approval date: March 12, 2012
    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
      ✓ 
      Pediatric exclusivity
  • 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
      ✓ 
      Pediatric exclusivity
  • 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
      ✓ 
      Drug product
    • June 18, 2019
      ✓ 
      Pediatric exclusivity
  • 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
      ✓ 
      Patent use: TREATMENT OF EPILEPSY
    • June 18, 2019
      ✓ 
      Pediatric exclusivity
  • 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
      ✓ 
      Patent use: TREATMENT OF EPILEPSY AND/OR MIGRAINE.
      ✓ 
      Drug product
    • June 18, 2019
      ✓ 
      Pediatric exclusivity
  • 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
      ✓ 
      Drug product
    • June 18, 2019
      ✓ 
      Pediatric exclusivity

Glossary

TermDefinition
Drug PatentA drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug ExclusivityExclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLDA Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.
ABProducts meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (i.e., identical active ingredients(s), dosage form, and route(s) of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (i.e., AB1, AB2, AB3, etc.). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.
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