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. Thirty-nine 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: | 39 |
Raw Ingredient (Bulk) Api Vendors: | 53 |
Clinical Trials: | 68 |
Patent Applications: | 7,027 |
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 |
Recent Clinical Trials for divalproex sodium
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Syneos Health | Phase 1 |
Nuventra | Phase 1 |
Emalex Biosciences Inc. | Phase 1 |
Generic filers with tentative approvals for DIVALPROEX SODIUM
Applicant | Application No. | Strength | Dosage Form |
⤷ Free Trial | ⤷ Free Trial | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE;ORAL |
⤷ Free Trial | ⤷ Free Trial | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE;ORAL |
⤷ Free Trial | ⤷ Free Trial | EQ 250MG 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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Lupin Ltd | DIVALPROEX SODIUM | divalproex sodium | TABLET, EXTENDED RELEASE;ORAL | 209286-002 | Oct 18, 2019 | AB | RX | No | No | ⤷ Free Trial | ⤷ Free Trial | ⤷ Free Trial | |||
Utopic Pharms | DIVALPROEX SODIUM | divalproex sodium | TABLET, EXTENDED RELEASE;ORAL | 214462-002 | Mar 15, 2021 | DISCN | No | No | ⤷ Free Trial | ⤷ Free Trial | ⤷ Free Trial | ||||
Zydus Pharms Usa Inc | DIVALPROEX SODIUM | divalproex sodium | TABLET, EXTENDED RELEASE;ORAL | 078239-001 | Feb 27, 2009 | AB | RX | No | No | ⤷ Free Trial | ⤷ Free Trial | ⤷ Free Trial | |||
Invatech | DIVALPROEX SODIUM | divalproex sodium | TABLET, DELAYED RELEASE;ORAL | 078290-002 | Jul 29, 2008 | AB | RX | No | No | ⤷ Free Trial | ⤷ Free Trial | ⤷ Free Trial | |||
Mylan | DIVALPROEX SODIUM | divalproex sodium | TABLET, EXTENDED RELEASE;ORAL | 077567-001 | Jan 29, 2009 | AB | RX | No | No | ⤷ Free Trial | ⤷ Free Trial | ⤷ Free Trial | |||
Unichem Labs Ltd | DIVALPROEX SODIUM | divalproex sodium | TABLET, DELAYED RELEASE;ORAL | 079163-003 | Apr 5, 2011 | AB | RX | No | No | ⤷ Free Trial | ⤷ Free Trial | ⤷ Free 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 ER | divalproex sodium | TABLET, EXTENDED RELEASE;ORAL | 021168-001 | Aug 4, 2000 | ⤷ Free Trial | ⤷ Free Trial |
Abbvie | DEPAKOTE ER | divalproex sodium | TABLET, EXTENDED RELEASE;ORAL | 021168-002 | May 31, 2002 | ⤷ Free Trial | ⤷ Free Trial |
Abbvie | DEPAKOTE ER | divalproex sodium | TABLET, EXTENDED RELEASE;ORAL | 021168-001 | Aug 4, 2000 | ⤷ Free Trial | ⤷ Free Trial |
Abbvie | DEPAKOTE ER | divalproex sodium | TABLET, EXTENDED RELEASE;ORAL | 021168-001 | Aug 4, 2000 | ⤷ Free Trial | ⤷ Free Trial |
Abbvie | DEPAKOTE | divalproex sodium | CAPSULE, DELAYED REL PELLETS;ORAL | 019680-001 | Sep 12, 1989 | ⤷ Free Trial | ⤷ Free Trial |
Abbvie | DEPAKOTE ER | divalproex sodium | TABLET, EXTENDED RELEASE;ORAL | 021168-001 | Aug 4, 2000 | ⤷ Free Trial | ⤷ Free Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Divalproex Sodium Market Dynamics and Financial Trajectory
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