DIVALPROEX SODIUM Drug Patent Profile
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When do Divalproex Sodium patents expire, and when can generic versions of Divalproex Sodium launch?
Divalproex Sodium is a drug marketed by Ajanta Pharma Ltd, Dr Reddys Labs Ltd, Rising, Teva Pharms Usa, Zydus Pharms Usa Inc, 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 thirty-six NDAs.
The generic ingredient in DIVALPROEX SODIUM is divalproex sodium. There are eighteen drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the divalproex sodium profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Divalproex Sodium
A generic version of DIVALPROEX SODIUM was approved as divalproex sodium by APOTEX on July 29th, 2008.
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Summary for DIVALPROEX SODIUM
| US Patents: | 0 |
| Applicants: | 29 |
| NDAs: | 36 |
| Finished Product Suppliers / Packagers: | 40 |
| Raw Ingredient (Bulk) Api Vendors: | 53 |
| Clinical Trials: | 68 |
| Patent Applications: | 4,850 |
| Drug Prices: | Drug price information for DIVALPROEX SODIUM |
| What excipients (inactive ingredients) are in DIVALPROEX SODIUM? | DIVALPROEX SODIUM excipients list |
| DailyMed Link: | DIVALPROEX SODIUM at DailyMed |
See drug prices for DIVALPROEX SODIUM
Recent Clinical Trials for DIVALPROEX SODIUM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Emalex Biosciences Inc. | Phase 1 |
| Syneos Health | Phase 1 |
| Nuventra | Phase 1 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Utopic Pharms | DIVALPROEX SODIUM | divalproex sodium | TABLET, EXTENDED RELEASE;ORAL | 214462-001 | Mar 15, 2021 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Teva | DIVALPROEX SODIUM | divalproex sodium | TABLET, DELAYED RELEASE;ORAL | 076941-001 | Jul 29, 2008 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Orbion Pharms | DIVALPROEX SODIUM | divalproex sodium | TABLET, DELAYED RELEASE;ORAL | 078853-001 | Nov 25, 2008 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Upsher Smith Labs | DIVALPROEX SODIUM | divalproex sodium | TABLET, DELAYED RELEASE;ORAL | 078182-003 | Jul 29, 2008 | 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 |
