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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, Mylan, Teva Pharms Usa, Zydus Pharms Usa Inc, Abbott, Actavis Labs Fl Inc, Anchen Pharms, Apotex, Aurobindo Pharma Ltd, Celltrion, Invatech, Lupin, Orchid Hlthcare, Prinston Inc, Sun Pharm Inds, Teva, Unichem Labs Ltd, Upsher Smith Labs, Amneal Pharms, Cosette, Impax Labs, Lupin Ltd, Reddys, and Wockhardt, and is included in thirty-seven 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: | 26 |
| NDAs: | 37 |
| Drug Master File Entries: | 18 |
| Finished Product Suppliers / Packagers: | 41 |
| Raw Ingredient (Bulk) Api Vendors: | 56 |
| Clinical Trials: | 63 |
| Patent Applications: | 5,781 |
| 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 |
Recent Clinical Trials for divalproex sodium
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Universidad Autonoma de San Luis Potosí | Phase 3 |
| Puma Biotechnology, Inc. | Phase 1/Phase 2 |
| Virginia Commonwealth University | Phase 1/Phase 2 |
Generic filers with tentative approvals for DIVALPROEX SODIUM
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE;ORAL |
| Start Trial | Start Trial | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE;ORAL |
| Start Trial | Start Trial | 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 | NDA | Submissiondate |
|---|---|---|---|---|
| DEPAKOTE ER | TABLET, EXTENDED RELEASE;ORAL | divalproex sodium | 021168 | 2005-02-08 |
| DEPAKOTE ER | TABLET, EXTENDED RELEASE;ORAL | divalproex sodium | 021168 | 2004-05-03 |
| DEPAKOTE | TABLET, DELAYED RELEASE;ORAL | divalproex sodium | 018723 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mylan | DIVALPROEX SODIUM | divalproex sodium | TABLET, DELAYED RELEASE;ORAL | 090062-001 | Mar 17, 2009 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Wockhardt | DIVALPROEX SODIUM | divalproex sodium | TABLET, EXTENDED RELEASE;ORAL | 078705-001 | Aug 4, 2009 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Aurobindo Pharma Ltd | DIVALPROEX SODIUM | divalproex sodium | TABLET, EXTENDED RELEASE;ORAL | 202419-001 | Jun 2, 2014 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| >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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Abbvie | DEPAKOTE | divalproex sodium | TABLET, DELAYED RELEASE;ORAL | 018723-003 | Oct 26, 1984 | Start Trial | Start Trial |
| Abbvie | DEPAKOTE | divalproex sodium | TABLET, DELAYED RELEASE;ORAL | 018723-003 | Oct 26, 1984 | Start Trial | Start Trial |
| Abbvie | DEPAKOTE ER | divalproex sodium | TABLET, EXTENDED RELEASE;ORAL | 021168-002 | May 31, 2002 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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