Assyro AI

FDA Orange Book · active-ingredient family

Diclofenac sodium

Diclofenac sodium is approved as 9 brand and 57 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:DYLOJECT · NDA 022396

9

Brand (NDA)

57

Generics (ANDA)

20

Listed patents

0

Exclusivity periods

Brand (NDA) products · gel, solution, solution/drops, tablet, delayed release, tablet, extended release

ProductApplicantApplicationTEApproved
DYLOJECTRLDJAVELIN PHARMS INCNDA 022396—Dec 23, 2014
PENNSAIDRLDHORIZONNDA 204623—Jan 16, 2014
PENNSAIDRLDNUVO PHARMS INCNDA 020947—Nov 04, 2009
VOLTAREN ARTHRITIS PAINRLDHALEON US HOLDINGSNDA 022122—Oct 17, 2007
SOLARAZERLDFOUGERA PHARMSNDA 021005—Oct 16, 2000
VOLTAREN-XRRLDNOVARTISNDA 020254—Mar 08, 1996
VOLTARENRLDNOVARTISNDA 020037—Mar 28, 1991
VOLTARENRLD×3NOVARTISNDA 019201—Jul 28, 1988
DICLOFENAC SODIUMFALCON PHARMSNDA 020809—May 04, 1998

Generic (ANDA) products (57)

ProductApplicantApplicationTEApproved
DICLOFENAC SODIUM×3UMEDICAANDA 219945ABNov 05, 2025
DICLOFENAC SODIUMENCUBEANDA 217646ABApr 09, 2025
DICLOFENAC SODIUM×3RUBICON RESEARCHANDA 216548ABMay 11, 2023
DICLOFENAC SODIUMAUROLIFE PHARMA LLCANDA 213040ABFeb 03, 2023
DICLOFENAC SODIUMALEMBICANDA 212506ABNov 29, 2022
DICLOFENAC SODIUMSUN PHARMA CANADAANDA 208098ABSep 29, 2022
DICLOFENAC SODIUMINGENUS PHARMS LLCANDA 216275ABSep 23, 2022
DICLOFENAC SODIUMLUPIN PHARMSANDA 208021ABSep 20, 2022
DICLOFENAC SODIUMAMNEALANDA 208198ABAug 18, 2022
DICLOFENAC SODIUMALEMBICANDA 212351BXJul 27, 2022
DICLOFENAC SODIUMAPOTEXANDA 207714ABMay 06, 2022
DICLOFENAC SODIUMEPIC PHARMA LLCANDA 206655ATJan 28, 2021
DICLOFENAC SODIUMENCUBEANDA 210986—Jan 27, 2020
DICLOFENAC SODIUMRISINGANDA 208786—Jun 18, 2019
DICLOFENAC SODIUMPERRIGO PHARMA INTLANDA 211253—May 16, 2019
DICLOFENAC SODIUMAUROLIFE PHARMA LLCANDA 204306—May 06, 2019
DICLOFENAC SODIUMHIKMAANDA 209484—Nov 21, 2018
DICLOFENAC SODIUMCIPLAANDA 209903—Aug 03, 2018
DICLOFENAC SODIUMPADAGIS ISRAELANDA 210893ABJul 27, 2018
DICLOFENAC SODIUMZYDUS LIFESCIENCESANDA 206411ATApr 17, 2018
DICLOFENAC SODIUMRISINGANDA 206715—Aug 07, 2017
DICLOFENAC SODIUMGLENMARK PHARMS LTDANDA 208301ABSep 13, 2016
DICLOFENAC SODIUMAMNEAL PHARMSANDA 206116ATSep 02, 2016
DICLOFENAC SODIUMSUN PHARMA CANADAANDA 206298ABApr 28, 2016
DICLOFENAC SODIUMAMNEAL PHARMSANDA 208077—Mar 18, 2016
DICLOFENAC SODIUMNOVEL LABS INCANDA 205878ATDec 09, 2015
DICLOFENAC SODIUMACTAVIS MID ATLANTICANDA 206493ABDec 02, 2015
DICLOFENAC SODIUMALTAIRE PHARMS INCANDA 203383ATNov 16, 2015
DICLOFENAC SODIUMLUPINANDA 204132ATAug 20, 2015
DICLOFENAC SODIUMPAI HOLDINGS PHARMANDA 202769—Jul 08, 2015
DICLOFENAC SODIUMSUN PHARMA CANADAANDA 203818ATNov 26, 2014
DICLOFENAC SODIUMTWI PHARMSANDA 202393—Nov 24, 2014
DICLOFENAC SODIUMWATSON LABS INCANDA 202852ATNov 24, 2014
DICLOFENAC SODIUMAPOTEXANDA 202027—May 27, 2014
DICLOFENAC SODIUMAMNEALANDA 200936—Oct 28, 2013
DICLOFENAC SODIUM×2UNIQUEANDA 090066ABDec 01, 2010
DICLOFENAC SODIUMRUBICON RESEARCHANDA 077600ATNov 13, 2008
DICLOFENAC SODIUMSCIEGEN PHARMSANDA 077845—Apr 17, 2008
DICLOFENAC SODIUMSANDOZANDA 078031ATFeb 06, 2008
DICLOFENAC SODIUMBAUSCH AND LOMBANDA 078792ATDec 28, 2007
DICLOFENAC SODIUMRISINGANDA 078553ATDec 28, 2007
DICLOFENAC SODIUMUNIQUEANDA 077863ABJun 08, 2007
DICLOFENAC SODIUMDEXCEL LTDANDA 076201ABNov 06, 2002
DICLOFENAC SODIUM×2AUROBINDO PHARMA USAANDA 075281ABFeb 12, 2002
DICLOFENAC SODIUMACTAVIS ELIZABETHANDA 075910—Jan 07, 2002
DICLOFENAC SODIUMAUROBINDO PHARMA USAANDA 076152—Dec 13, 2001
DICLOFENAC SODIUMVPNAANDA 075492ABFeb 11, 2000
DICLOFENAC SODIUM×2PLIVAANDA 074432—Jul 29, 1999
DICLOFENAC SODIUMTEVAANDA 074723—Mar 30, 1999
DICLOFENAC SODIUM×2MICRO LABSANDA 074986—Feb 26, 1999
DICLOFENAC SODIUM×3CARLSBADANDA 075185ABNov 13, 1998
DICLOFENAC SODIUM×3TEVA PHARMSANDA 074459—Jun 25, 1997
DICLOFENAC SODIUMTEVAANDA 074390—Aug 15, 1996
DICLOFENAC SODIUM×2ACTAVIS ELIZABETHANDA 074514ABMar 26, 1996
DICLOFENAC SODIUMCHARTWELL RXANDA 074394—Nov 30, 1995
DICLOFENAC SODIUM×2CHARTWELL RXANDA 074376—Sep 28, 1995
DICLOFENAC SODIUM×3ROXANEANDA 074391—Jun 29, 1995

Listed patents (20)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8946292Mar 22, 2027in 9 mo
U-1659
9132110Oct 17, 2027in 1 yr 4 mo
U-1488
9168305Oct 17, 2027in 1 yr 4 mo
U-1488
9066913Oct 17, 2027in 1 yr 4 mo
ProductU-1488
9339551Oct 17, 2027in 1 yr 4 mo
U-1488
9220784Oct 17, 2027in 1 yr 4 mo
U-1488
9339552Oct 17, 2027in 1 yr 4 mo
ProductU-1488
9539335Oct 17, 2027in 1 yr 4 mo
U-1614
8563613Oct 17, 2027in 1 yr 4 mo
ProductU-1488
8871809Oct 17, 2027in 1 yr 4 mo
U-1614
9101591Oct 17, 2027in 1 yr 4 mo
ProductU-1488
9168304Oct 17, 2027in 1 yr 4 mo
Product
8252838Apr 21, 2028in 1 yr 10 mo
ProductU-1489
8741956Jul 10, 2029in 3 yr 1 mo
U-1435
8618164Jul 10, 2029in 3 yr 1 mo
U-1477
9370501Jul 10, 2029in 3 yr 1 mo
U-1614
8217078Jul 10, 2029in 3 yr 1 mo
U-1477
9375412Jul 10, 2029in 3 yr 1 mo
U-1614
9415029Jul 10, 2029in 3 yr 1 mo
U-1614
8546450Aug 09, 2030in 4 yr 2 mo
U-1435

Diclofenac sodium — frequently asked questions

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

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo