DIVALPROEX SODIUM - Generic Drug Details
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What are the generic drug sources for divalproex sodium and what is the scope of patent protection?
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, Anchen Pharms, Apotex, Aurobindo Pharma Ltd, Chartwell Rx, Invatech, Lupin, Mylan, Orbion Pharms, Prinston Inc, Sun Pharm Inds, Teva, Unichem Labs Ltd, Upsher Smith Labs, Amneal Pharms, Amta, Annora Pharma, Cosette, Impax Labs, Lupin Ltd, Reddys, Unichem, 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. Forty suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for DIVALPROEX SODIUM
US Patents: | 0 |
Tradenames: | 4 |
Applicants: | 30 |
NDAs: | 40 |
Drug Master File Entries: | 18 |
Finished Product Suppliers / Packagers: | 40 |
Raw Ingredient (Bulk) Api Vendors: | 67 |
Clinical Trials: | 68 |
Patent Applications: | 7,028 |
Formulation / Manufacturing: | see details |
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 |
---|---|
Nuventra | Phase 1 |
Emalex Biosciences Inc. | Phase 1 |
Syneos Health | Phase 1 |
Generic filers with tentative approvals for DIVALPROEX SODIUM
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE;ORAL |
⤷ Sign Up | ⤷ Sign Up | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE;ORAL |
⤷ Sign Up | ⤷ Sign Up | 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 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Zydus Pharms Usa Inc | DIVALPROEX SODIUM | divalproex sodium | TABLET, DELAYED RELEASE;ORAL | 077100-001 | Mar 5, 2009 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Lupin Ltd | DIVALPROEX SODIUM | divalproex sodium | TABLET, EXTENDED RELEASE;ORAL | 209286-002 | Oct 18, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Unichem | DIVALPROEX SODIUM | divalproex sodium | TABLET, EXTENDED RELEASE;ORAL | 214643-002 | Feb 25, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Mylan | DIVALPROEX SODIUM | divalproex sodium | TABLET, DELAYED RELEASE;ORAL | 090062-001 | Mar 17, 2009 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Wockhardt | DIVALPROEX SODIUM | divalproex sodium | TABLET, EXTENDED RELEASE;ORAL | 078705-002 | Feb 10, 2009 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
>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 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | DEPAKOTE | divalproex sodium | TABLET, DELAYED RELEASE;ORAL | 018723-001 | Mar 10, 1983 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | DEPAKOTE ER | divalproex sodium | TABLET, EXTENDED RELEASE;ORAL | 021168-001 | Aug 4, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | DEPAKOTE ER | divalproex sodium | TABLET, EXTENDED RELEASE;ORAL | 021168-002 | May 31, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | DEPAKOTE ER | divalproex sodium | TABLET, EXTENDED RELEASE;ORAL | 021168-001 | Aug 4, 2000 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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