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FDA Orange Book · active-ingredient family

Divalproex sodium

Divalproex sodium is approved as 4 brand and 38 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:DEPAKOTE ER · NDA 021168

4

Brand (NDA)

38

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule, delayed rel pellets, tablet, delayed release, tablet, extended release

ProductApplicantApplicationTEApproved
DEPAKOTE ERRLD×2ABBVIENDA 021168ABMay 31, 2002
DEPAKOTERLDABBVIENDA 019680ABSep 12, 1989
DEPAKOTERLD×3ABBVIENDA 018723ABOct 26, 1984
DEPAKOTE CP×2ABBOTTNDA 019794—Jul 11, 1990

Generic (ANDA) products (38)

ProductApplicantApplicationTEApproved
DIVALPROEX SODIUMMANKIND PHARMAANDA 217358ABAug 12, 2025
DIVALPROEX SODIUMALEMBICANDA 218793ABDec 19, 2024
DIVALPROEX SODIUM×2ANNORA PHARMAANDA 215527ABSep 26, 2023
DIVALPROEX SODIUM×2UNICHEMANDA 214643ABFeb 25, 2022
DIVALPROEX SODIUM×2YICHANG HUMANWELLANDA 214462—Mar 15, 2021
DIVALPROEX SODIUMTEVA PHARMS USAANDA 211505—Nov 17, 2020
DIVALPROEX SODIUMAJANTA PHARMA LTDANDA 213181ABMar 02, 2020
DIVALPROEX SODIUM×2LUPINANDA 209286ABOct 18, 2019
DIVALPROEX SODIUM×2AMNEAL PHARMSANDA 203730ABMay 29, 2015
DIVALPROEX SODIUM×2AUROBINDO PHARMA LTDANDA 202419ABJun 02, 2014
DIVALPROEX SODIUMDR REDDYS LABS LTDANDA 090161ABMar 15, 2012
DIVALPROEX SODIUMREDDYSANDA 090070ABMar 12, 2012
DIVALPROEX SODIUM×3AUROBINDO PHARMA LTDANDA 090554ABApr 21, 2011
DIVALPROEX SODIUM×3UNICHEM LABS LTDANDA 079163ABApr 05, 2011
DIVALPROEX SODIUMRISINGANDA 090407—Mar 28, 2011
DIVALPROEX SODIUMACTAVIS LABS FL INCANDA 079080—Feb 25, 2011
DIVALPROEX SODIUM×3PRINSTON INCANDA 090210ABNov 30, 2009
DIVALPROEX SODIUMCOSETTEANDA 078700—Aug 03, 2009
DIVALPROEX SODIUM×2IMPAX LABSANDA 078791—May 06, 2009
DIVALPROEX SODIUM×3PHARMOBEDIENTANDA 090062—Mar 17, 2009
DIVALPROEX SODIUM×3ZYDUS PHARMS USA INCANDA 077100ABMar 05, 2009
DIVALPROEX SODIUM×2ZYDUS PHARMS USA INCANDA 078239ABFeb 27, 2009
DIVALPROEX SODIUM×2PH HEALTHANDA 078445—Feb 26, 2009
DIVALPROEX SODIUM×2SCIEGEN PHARMSANDA 078705ABFeb 10, 2009
DIVALPROEX SODIUM×2MYLANANDA 077567ABJan 29, 2009
DIVALPROEX SODIUMZYDUS PHARMS USA INCANDA 078919ABJan 27, 2009
DIVALPROEX SODIUMDR REDDYS LABS LTDANDA 078979ABJan 23, 2009
DIVALPROEX SODIUM×3ORBION PHARMSANDA 078853ABNov 25, 2008
DIVALPROEX SODIUMPH HEALTHANDA 078411—Nov 03, 2008
DIVALPROEX SODIUM×3CHARTWELL RXANDA 077296ABJul 31, 2008
DIVALPROEX SODIUM×3APOTEXANDA 077615—Jul 29, 2008
DIVALPROEX SODIUM×3DR REDDYS LABS LTDANDA 078755ABJul 29, 2008
DIVALPROEX SODIUM×3INVATECHANDA 078290ABJul 29, 2008
DIVALPROEX SODIUM×3LUPINANDA 078790—Jul 29, 2008
DIVALPROEX SODIUM×3MYLANANDA 077254—Jul 29, 2008
DIVALPROEX SODIUM×3SUN PHARM INDSANDA 078597ABJul 29, 2008
DIVALPROEX SODIUM×3TEVAANDA 076941—Jul 29, 2008
DIVALPROEX SODIUM×3UPSHER SMITH LABSANDA 078182ABJul 29, 2008

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Divalproex sodium — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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