Valproate sodium - Generic Drug Details
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What are the generic drug sources for valproate sodium and what is the scope of freedom to operate?
Valproate sodium
is the generic ingredient in two branded drugs marketed by Abbvie, Fresenius Kabi Usa, Hikma Farmaceutica, Mylan, and Sagent, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.Three suppliers are listed for this compound.
Summary for valproate sodium
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 5 |
NDAs: | 5 |
Finished Product Suppliers / Packagers: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 112 |
Clinical Trials: | 62 |
Patent Applications: | 6,753 |
Formulation / Manufacturing: | see details |
What excipients (inactive ingredients) are in valproate sodium? | valproate sodium excipients list |
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 |
Kathmandu University | Phase 4 |
Australasian Gastro-Intestinal Trials Group | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Abbvie | DEPACON | valproate sodium | INJECTABLE;INJECTION | 020593-001 | Dec 30, 1996 | DISCN | Yes | 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 | ||||
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 | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
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