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FDA Orange Book · active-ingredient family

Naproxen sodium

Naproxen sodium is approved as 4 brand and 39 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:NAPROXEN SODIUM · NDA 021920

4

Brand (NDA)

39

Generics (ANDA)

5

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule, tablet, tablet, extended release

ProductApplicantApplicationTEApproved
NAPROXEN SODIUMRLDBIONPHARMANDA 021920—Feb 17, 2006
NAPRELANRLD×3TWI PHARMSNDA 020353ABJan 05, 1996
ALEVERLDBAYERNDA 020204—Jan 11, 1994
ANAPROXRLD×2ATNAHS PHARMA USNDA 018164—Approved Prior to Jan 1, 1982

Generic (ANDA) products (39)

ProductApplicantApplicationTEApproved
NAPROXEN SODIUMPATHEON SOFTGELSANDA 214463—Jan 10, 2023
NAPROXEN SODIUMHETERO LABS LTD VANDA 211065—Oct 28, 2022
NAPROXEN SODIUMONESOURCE SPECIALTYANDA 215472—Aug 17, 2022
NAPROXEN SODIUM×2SCIEGEN PHARMSANDA 212199ABOct 30, 2019
NAPROXEN SODIUMYICHANG HUMANWELLANDA 212033—Aug 30, 2019
NAPROXEN SODIUMCATALENTANDA 202807—Jan 04, 2019
NAPROXEN SODIUMNOVELGENIX THERAPSANDA 207612—Nov 16, 2018
NAPROXEN SODIUMPURACAP PHARM LLCANDA 208363—Mar 15, 2018
NAPROXEN SODIUMLNK INTL INCANDA 204872—Jan 23, 2017
NAPROXEN SODIUMAUROBINDO PHARMA LTDANDA 205497—Mar 18, 2016
NAPROXEN SODIUM×2AUROBINDO PHARMA LTDANDA 200629ABOct 31, 2011
NAPROXEN SODIUMGRANULES INDIAANDA 091353—Sep 20, 2011
NAPROXEN SODIUMSUN PHARM INDS LTDANDA 091183—May 20, 2011
NAPROXEN SODIUMMARKSANS PHARMAANDA 090545—Mar 16, 2011
NAPROXEN SODIUMAMNEAL PHARMS NYANDA 079096—Dec 16, 2008
NAPROXEN SODIUM×2DR REDDYS LABS LTDANDA 078486ABJul 26, 2007
NAPROXEN SODIUM×2GLENMARK PHARMS LTDANDA 078314ABApr 27, 2007
NAPROXEN SODIUM×2AMNEAL PHARMS NYANDA 078432—Apr 25, 2007
NAPROXEN SODIUM×2ABLEANDA 076544—Aug 22, 2003
NAPROXEN SODIUM×3ACTAVIS LABS FL INCANDA 075416ABApr 23, 2003
NAPROXEN SODIUMDR REDDYS LABS INCANDA 075168—Jul 28, 1998
NAPROXEN SODIUM×2HIKMAANDA 074480—Feb 18, 1998
NAPROXEN SODIUMCONTRACT PHARMACALANDA 074789—Feb 27, 1997
NAPROXEN SODIUMCONTRACT PHARMACALANDA 074635—Jan 13, 1997
NAPROXEN SODIUMPERRIGOANDA 074661—Jan 13, 1997
NAPROXEN SODIUMPLD ACQUISITIONS LLCANDA 074646—Jan 13, 1997
NAPROXEN SODIUM×2PLIVAANDA 074242—Jun 20, 1996
NAPROXEN SODIUM×2WATSON LABSANDA 074455—May 31, 1995
NAPROXEN SODIUM×2PUREPAC PHARMANDA 074319—Mar 20, 1995
NAPROXEN SODIUM×2IVAX SUB TEVA PHARMSANDA 074230—Mar 14, 1995
NAPROXEN SODIUM×2SANDOZANDA 074495—Dec 05, 1994
NAPROXEN SODIUM×2PHARMOBEDIENTANDA 074367—Aug 31, 1994
NAPROXEN SODIUM×2TEVA PHARMSANDA 074289—Jan 27, 1994
NAPROXEN SODIUM×2ROXANEANDA 074257—Dec 21, 1993
NAPROXEN SODIUM×2SANDOZANDA 074162—Dec 21, 1993
NAPROXEN SODIUM×2TEVAANDA 074142—Dec 21, 1993
NAPROXEN SODIUM×2TEVAANDA 074198—Dec 21, 1993
NAPROXEN SODIUM×2WATSON LABSANDA 074195—Dec 21, 1993
NAPROXEN SODIUM×2HAMILTON PHARMSANDA 074106—Aug 31, 1993

Listed patents (5)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10028925Mar 03, 20264 mo ago
ProductU-1731
10022344Mar 03, 20264 mo ago
ProductU-1731
11090280Mar 03, 20264 mo ago
ProductU-1731
9693979Mar 03, 20264 mo ago
Product
9693978Mar 03, 20264 mo ago
Product

Naproxen sodium — frequently asked questions

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

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