Divalproex sodium - Generic Drug Details
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What are the generic sources for divalproex sodium and what is the scope of freedom to operate?
Divalproex sodium
is the generic ingredient in four branded drugs marketed by Abbvie, Ajanta Pharma Ltd, Dr Reddys Labs Ltd, Mylan, Teva Pharms Usa, Zydus Pharms Usa Inc, Abbott, Actavis Labs Fl Inc, Anchen Pharms, Apotex, Aurobindo Pharma Ltd, Celltrion, Invatech, Lupin, Orbion Pharms, Prinston Inc, Sun Pharm Inds, Teva, Unichem Labs Ltd, Upsher Smith Labs, Amneal Pharms, Amta, Cosette, Impax Labs, Lupin Ltd, Reddys, Unichem, and Wockhardt, and is included in thirty-nine NDAs. Additional information is available in the individual branded drug profile pages.There are eighteen drug master file entries for divalproex sodium. Forty-two suppliers are listed for this compound.
Summary for divalproex sodium
US Patents: | 0 |
Tradenames: | 4 |
Applicants: | 28 |
NDAs: | 39 |
Drug Master File Entries: | 18 |
Finished Product Suppliers / Packagers: | 42 |
Raw Ingredient (Bulk) Api Vendors: | 61 |
Clinical Trials: | 68 |
Patent Applications: | 7,149 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for divalproex sodium |
Drug Sales Revenues: | Drug sales revenues for divalproex sodium |
What excipients (inactive ingredients) are in divalproex sodium? | divalproex sodium excipients list |
DailyMed Link: | divalproex sodium at DailyMed |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Invatech | DIVALPROEX SODIUM | divalproex sodium | TABLET, DELAYED RELEASE;ORAL | 078290-002 | Jul 29, 2008 | AB | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Aurobindo Pharma Ltd | DIVALPROEX SODIUM | divalproex sodium | TABLET, DELAYED RELEASE;ORAL | 090554-002 | Apr 21, 2011 | AB | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Invatech | DIVALPROEX SODIUM | divalproex sodium | TABLET, DELAYED RELEASE;ORAL | 078290-003 | Jul 29, 2008 | AB | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Mylan | DIVALPROEX SODIUM | divalproex sodium | CAPSULE, DELAYED REL PELLETS;ORAL | 090407-001 | Mar 28, 2011 | DISCN | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Celltrion | DIVALPROEX SODIUM | divalproex sodium | TABLET, DELAYED RELEASE;ORAL | 077296-002 | Jul 31, 2008 | AB | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
>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 divalproex sodium
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Abbvie | DEPAKOTE ER | divalproex sodium | TABLET, EXTENDED RELEASE;ORAL | 021168-001 | Aug 4, 2000 | See Plans and Pricing | See Plans and Pricing |
Abbvie | DEPAKOTE | divalproex sodium | TABLET, DELAYED RELEASE;ORAL | 018723-002 | Mar 10, 1983 | See Plans and Pricing | See Plans and Pricing |
Abbvie | DEPAKOTE | divalproex sodium | TABLET, DELAYED RELEASE;ORAL | 018723-003 | Oct 26, 1984 | See Plans and Pricing | See Plans and Pricing |
Abbvie | DEPAKOTE ER | divalproex sodium | TABLET, EXTENDED RELEASE;ORAL | 021168-001 | Aug 4, 2000 | See Plans and Pricing | See Plans and Pricing |
Abbvie | DEPAKOTE | divalproex sodium | CAPSULE, DELAYED REL PELLETS;ORAL | 019680-001 | Sep 12, 1989 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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