Depakote Er is a drug owned by Abbvie Inc. It is protected by 12 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 18, 2019. Details of Depakote Er's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US6528090 (Pediatric) | Controlled release formulation of divalproex sodium |
Jun, 2019
(5 years ago) |
Expired
|
|
US6511678 (Pediatric) | Controlled release formulation of divalproex sodium |
Jun, 2019
(5 years ago) |
Expired
|
|
US6419953 (Pediatric) | Controlled release formulation of divalproex sodium |
Jun, 2019
(5 years ago) |
Expired
|
|
US6720004 (Pediatric) | Controlled release formulation of divalproex sodium |
Jun, 2019
(5 years ago) |
Expired
|
|
US6713086 (Pediatric) | Controlled release formulation of divalproex sodium |
Jun, 2019
(5 years ago) |
Expired
|
|
US6528091 (Pediatric) | Controlled release formulation of divalproex sodium |
Jun, 2019
(5 years ago) |
Expired
|
| US6528090 | Controlled release formulation of divalproex sodium |
Dec, 2018
(5 years ago) |
Expired
|
| US6713086 | Controlled release formulation of divalproex sodium |
Dec, 2018
(5 years ago) |
Expired
|
| US6528091 | Controlled release formulation of divalproex sodium |
Dec, 2018
(5 years ago) |
Expired
|
| US6720004 | Controlled release formulation of divalproex sodium |
Dec, 2018
(5 years ago) |
Expired
|
| US6511678 | Controlled release formulation of divalproex sodium |
Dec, 2018
(5 years ago) |
Expired
|
| US6419953 | Controlled release formulation of divalproex sodium |
Dec, 2018
(5 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Depakote Er's patents.
Latest Legal Activities on Depakote Er's Patents
Given below is the list of recent legal activities going on the following patents of Depakote Er.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Change in Power of Attorney (May Include Associate POA) Critical | 24 Sep, 2013 | US6528091 |
| Email Notification Critical | 24 Sep, 2013 | US6528091 |
| Correspondence Address Change Critical | 23 Sep, 2013 | US6528091 |
| Email Notification Critical | 05 Sep, 2013 | US6713086 |
| Change in Power of Attorney (May Include Associate POA) Critical | 05 Sep, 2013 | US6713086 |
| Change in Power of Attorney (May Include Associate POA) Critical | 04 Sep, 2013 | US6720004 |
| Email Notification Critical | 04 Sep, 2013 | US6720004 |
| Correspondence Address Change Critical | 04 Sep, 2013 | US6713086 |
| Correspondence Address Change Critical | 03 Sep, 2013 | US6720004 |
| Post Issue Communication - Certificate of Correction | 22 Aug, 2007 | US6713086 |
FDA has granted several exclusivities to Depakote Er. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Depakote Er, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Depakote Er.
Exclusivity Information
Depakote Er holds 1 exclusivities. All of its exclusivities have expired in 2011. Details of Depakote Er's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| Pediatric Exclusivity(PED) | Sep 24, 2011 |
US patents provide insights into the exclusivity only within the United States, but Depakote Er is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Depakote Er's family patents as well as insights into ongoing legal events on those patents.
Depakote Er's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Depakote Er's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 18, 2019 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Depakote Er Generic API suppliers:
Divalproex Sodium is the generic name for the brand Depakote Er. 29 different companies have already filed for the generic of Depakote Er, with Zydus Pharms Usa Inc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Depakote Er's generic
How can I launch a generic of Depakote Er before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Depakote Er's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Depakote Er's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Depakote Er -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 250 mg | 03 May, 2004 | ||||
| 500 mg | 08 Feb, 2005 |
Alternative Brands for Depakote Er
Depakote Er which is used for managing and preventing seizures in epilepsy and sometimes used for treating migraine headaches., has several other brand drugs in the same treatment category . Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||
|---|---|---|---|---|
| Catalyst Pharms |
| |||
| Eisai Inc |
| |||
| Supernus Pharms |
| |||
About Depakote Er
Depakote Er is a drug owned by Abbvie Inc. It is used for managing and preventing seizures in epilepsy and sometimes used for treating migraine headaches. Depakote Er uses Divalproex Sodium as an active ingredient. Depakote Er was launched by Abbvie in 2002.
Approval Date:
Depakote Er was approved by FDA for market use on 31 May, 2002.
Active Ingredient:
Depakote Er uses Divalproex Sodium as the active ingredient. Check out other Drugs and Companies using Divalproex Sodium ingredient
Treatment:
Depakote Er is used for managing and preventing seizures in epilepsy and sometimes used for treating migraine headaches.
Dosage:
Depakote Er is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE | Prescription | ORAL |