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, Mylan, 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.
Summary for VALPROATE SODIUM
US Patents: | 0 |
Applicants: | 4 |
NDAs: | 4 |
Finished Product Suppliers / Packagers: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 112 |
Clinical Trials: | 62 |
Patent Applications: | 4,551 |
Formulation / Manufacturing: | see details |
DailyMed Link: | VALPROATE SODIUM at DailyMed |
Recent Clinical Trials for VALPROATE SODIUM
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Assiut University | Phase 4 |
Olivia Newton-John Cancer Research Institute | Phase 2 |
Kathmandu University | Phase 4 |
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Sagent | VALPROATE SODIUM | valproate sodium | INJECTABLE;INJECTION | 076295-001 | Nov 14, 2002 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Hikma Farmaceutica | VALPROATE SODIUM | valproate sodium | INJECTABLE;INJECTION | 078523-001 | Feb 17, 2010 | AP | RX | No | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Mylan | VALPROATE SODIUM | valproate sodium | INJECTABLE;INJECTION | 208120-001 | Dec 22, 2021 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |