DEPAKOTE ER Drug Patent Profile
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Which patents cover Depakote Er, and when can generic versions of Depakote Er launch?
Depakote Er is a drug marketed by Abbvie and is included in one NDA.
The generic ingredient in DEPAKOTE ER is divalproex sodium. There are eighteen drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the divalproex sodium profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Depakote Er
A generic version of DEPAKOTE ER was approved as divalproex sodium by APOTEX on July 29th, 2008.
Summary for DEPAKOTE ER
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 67 |
Clinical Trials: | 97 |
Patent Applications: | 4,850 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for DEPAKOTE ER |
DailyMed Link: | DEPAKOTE ER at DailyMed |
Recent Clinical Trials for DEPAKOTE ER
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Puma Biotechnology, Inc. | Phase 1/Phase 2 |
Virginia Commonwealth University | Phase 1/Phase 2 |
Barretos Cancer Hospital | Early Phase 1 |
Pharmacology for DEPAKOTE ER
Drug Class | Anti-epileptic Agent Mood Stabilizer |
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Paragraph IV (Patent) Challenges for DEPAKOTE ER
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 DEPAKOTE ER
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Abbvie | DEPAKOTE ER | divalproex sodium | TABLET, EXTENDED RELEASE;ORAL | 021168-002 | May 31, 2002 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Abbvie | DEPAKOTE ER | divalproex sodium | TABLET, EXTENDED RELEASE;ORAL | 021168-001 | Aug 4, 2000 | AB | RX | Yes | 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 |
Expired US Patents for DEPAKOTE ER
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Abbvie | DEPAKOTE ER | divalproex sodium | TABLET, EXTENDED RELEASE;ORAL | 021168-002 | May 31, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
Abbvie | DEPAKOTE ER | divalproex sodium | TABLET, EXTENDED RELEASE;ORAL | 021168-002 | May 31, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
Abbvie | DEPAKOTE ER | divalproex sodium | TABLET, EXTENDED RELEASE;ORAL | 021168-002 | May 31, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for DEPAKOTE ER
See the table below for patents covering DEPAKOTE ER around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Colombia | 5160287 | FORMULACION DE LIBERACION CONTROLADA DE DIVALPROEX SODICO | ⤷ Try a Trial |
Poland | 356899 | ⤷ Try a Trial | |
World Intellectual Property Organization (WIPO) | 0037055 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |