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FDA Orange Book · active-ingredient family

Zolpidem tartrate

Zolpidem tartrate is approved as 7 brand and 36 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ZOLPIDEM TARTRATE · NDA 215721

7

Brand (NDA)

36

Generics (ANDA)

5

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule, spray, metered, tablet, tablet, extended release, tablet, orally disintegrating

ProductApplicantApplicationTEApproved
ZOLPIDEM TARTRATERLDALMATICANDA 215721ABMay 09, 2023
INTERMEZZORLD×2PURDUE PHARMANDA 022328—Nov 23, 2011
EDLUARRLD×2VIATRISNDA 021997ABMar 13, 2009
ZOLPIMISTRLDAYTUNDA 022196—Dec 19, 2008
TOVALT ODTRLD×2BIOVAIL LABS INTLNDA 021412—Apr 25, 2007
AMBIEN CRRLD×2COSETTENDA 021774ABSep 02, 2005
AMBIENRLD×2COSETTENDA 019908ABDec 16, 1992

Generic (ANDA) products (36)

ProductApplicantApplicationTEApproved
ZOLPIDEM TARTRATEUMEDICA LABS PVTANDA 220717ABMay 12, 2026
ZOLPIDEM TARTRATE×2BRECKENRIDGEANDA 213592ABJun 04, 2020
ZOLPIDEM TARTRATE×2PH HEALTHANDA 204229ABSep 11, 2017
ZOLPIDEM TARTRATE×2SUN PHARMANDA 204170ABJan 24, 2017
ZOLPIDEM TARTRATE×2DR REDDYSANDA 204503ABNov 18, 2016
ZOLPIDEM TARTRATE×2PHARMOBEDIENTANDA 202657—Aug 08, 2016
ZOLPIDEM TARTRATE×2PH HEALTHANDA 201509ABAug 01, 2016
ZOLPIDEM TARTRATE×2NOVEL LABS INCANDA 204299ABJun 03, 2015
ZOLPIDEM TARTRATE×2LUPINANDA 078970ABSep 11, 2013
ZOLPIDEM TARTRATE×2APOTEXANDA 200266—Sep 10, 2013
ZOLPIDEM TARTRATE×2ACTAVIS LABS FL INCANDA 090153—Mar 25, 2013
ZOLPIDEM TARTRATE×2CHARTWELL MOLECULARANDA 077388ABJul 30, 2012
ZOLPIDEM TARTRATE×2SANDOZANDA 090107ABJul 01, 2011
ZOLPIDEM TARTRATE×2PH HEALTHANDA 078148—Apr 14, 2011
ZOLPIDEM TARTRATE×2SYNTHON PHARMSANDA 078483—Apr 12, 2011
ZOLPIDEM TARTRATE×2ACTAVIS ELIZABETHANDA 078179—Oct 13, 2010
ZOLPIDEM TARTRATE×2STRIDES PHARMA INTLANDA 078616—Nov 21, 2008
ZOLPIDEM TARTRATE×2HIKMAANDA 078129—Apr 30, 2008
ZOLPIDEM TARTRATE×2INVAGEN PHARMSANDA 078184—Sep 07, 2007
ZOLPIDEM TARTRATE×2TORRENT PHARMSANDA 077903ABAug 17, 2007
ZOLPIDEM TARTRATE×2WOCKHARDTANDA 078426—May 15, 2007
ZOLPIDEM TARTRATE×2AUROBINDO PHARMAANDA 078413ABMay 04, 2007
ZOLPIDEM TARTRATE×2ACME LABSANDA 077214ABApr 23, 2007
ZOLPIDEM TARTRATE×2APOTEX INCANDA 077884—Apr 23, 2007
ZOLPIDEM TARTRATE×2MYLAN PHARMS INCANDA 078016—Apr 23, 2007
ZOLPIDEM TARTRATE×2RISINGANDA 076578—Apr 23, 2007
ZOLPIDEM TARTRATE×2SANDOZANDA 077322ABApr 23, 2007
ZOLPIDEM TARTRATE×2SENORES PHARMSANDA 077985—Apr 23, 2007
ZOLPIDEM TARTRATE×2STRIDES PHARMAANDA 076062—Apr 23, 2007
ZOLPIDEM TARTRATE×2SUN PHARM INDS INCANDA 077359—Apr 23, 2007
ZOLPIDEM TARTRATE×2SUN PHARM INDS LTDANDA 078055—Apr 23, 2007
ZOLPIDEM TARTRATE×2SUN PHARM INDUSTRIESANDA 077288—Apr 23, 2007
ZOLPIDEM TARTRATE×2SYNTHON PHARMSANDA 077540—Apr 23, 2007
ZOLPIDEM TARTRATE×2TEVAANDA 076410—Apr 23, 2007
ZOLPIDEM TARTRATE×2WATSON LABSANDA 077773—Apr 23, 2007
ZOLPIDEM TARTRATE×2YUNG SHIN PHARMANDA 077990—Apr 23, 2007

Listed patents (5)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9597281Apr 06, 2027in 10 mo
U-674
7658945Apr 15, 2027in 10 mo
ProductU-1194
8242131Aug 20, 2029in 3 yr 3 mo
U-1266
9265720Feb 25, 2031in 4 yr 9 mo
U-674
8236285Aug 07, 2032in 6 yr 3 mo
SubstanceProductU-70

Zolpidem tartrate — frequently asked questions

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

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