VALPROATE SODIUM Drug Patent Profile
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Which patents cover Valproate Sodium, and when can generic versions of Valproate Sodium launch?
Valproate Sodium is a drug marketed by Fresenius Kabi Usa, Hikma Farmaceutica, Norvium Bioscience, and Sagent. and is included in four NDAs.
The generic ingredient in VALPROATE SODIUM is valproate sodium. There are nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the valproate sodium profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Valproate Sodium
A generic version of VALPROATE SODIUM was approved as valproate sodium by SAGENT on November 14th, 2002.
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Summary for VALPROATE SODIUM
| US Patents: | 0 |
| Applicants: | 4 |
| NDAs: | 4 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 112 |
| Clinical Trials: | 63 |
| Patent Applications: | 4,551 |
| DailyMed Link: | VALPROATE SODIUM at DailyMed |
Recent Clinical Trials for VALPROATE SODIUM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of North Carolina, Chapel Hill | Phase 4 |
| Assiut University | Phase 4 |
| Olivia Newton-John Cancer Research Institute | Phase 2 |
Pharmacology for VALPROATE SODIUM
| Drug Class | Anti-epileptic Agent Mood Stabilizer |
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
US Patents and Regulatory Information for VALPROATE SODIUM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Fresenius Kabi Usa | VALPROATE SODIUM | valproate sodium | INJECTABLE;INJECTION | 076539-001 | Jun 26, 2003 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sagent | VALPROATE SODIUM | valproate sodium | INJECTABLE;INJECTION | 076295-001 | Nov 14, 2002 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hikma Farmaceutica | VALPROATE SODIUM | valproate sodium | INJECTABLE;INJECTION | 078523-001 | Feb 17, 2010 | AP | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Norvium Bioscience | VALPROATE SODIUM | valproate sodium | INJECTABLE;INJECTION | 208120-001 | Dec 22, 2021 | DISCN | 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 |
