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FDA Orange Book · active-ingredient family

Cetirizine hydrochloride

Cetirizine hydrochloride is approved as 8 brand and 64 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:CHILDREN'S ZYRTEC ALLERGY · NDA 021621

8

Brand (NDA)

64

Generics (ANDA)

11

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule, solution, solution/drops, tablet, tablet, chewable, tablet, orally disintegrating

ProductApplicantApplicationTEApproved
CHILDREN'S ZYRTEC ALLERGYRLD×5KENVUE BRANDSNDA 021621—Nov 30, 2020
QUZYTTIRRLDESTEVENDA 211415—Oct 04, 2019
ZERVIATERLDHARROW EYENDA 208694—May 30, 2017
ZYRTEC ALLERGYRLDKENVUE BRANDSNDA 022578—Sep 03, 2010
CETIRIZINE HYDROCHLORIDE ALLERGYRLD×4BIONPHARMANDA 022429—Jul 23, 2009
CHILDREN'S ZYRTEC ALLERGYRLD×2KENVUE BRANDSNDA 022155—Nov 16, 2007
ZYRTEC ALLERGYRLD×4KENVUE BRANDSNDA 019835—Nov 16, 2007
ZYRTECRLDJ AND J CONSUMER INCNDA 020346—Sep 27, 1996

Generic (ANDA) products (64)

ProductApplicantApplicationTEApproved
CETIRIZINE HYDROCHLORIDERUBICON RESEARCHANDA 220335AAFeb 25, 2026
CETIRIZINE HYDROCHLORIDEREGCON HOLDINGSANDA 218895—Oct 03, 2024
CETIRIZINE HYDROCHLORIDE ALLERGYCATALENTANDA 213105—Sep 21, 2020
CETIRIZINE HYDROCHLORIDEAUROBINDO PHARMA LTDANDA 213557—Sep 11, 2020
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGYQUAGENANDA 212266—May 16, 2019
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGYHETERO LABS LTD IIIANDA 210622—Mar 13, 2019
CETIRIZINE HYDROCHLORIDE ALLERGY×2AUROBINDO PHARMA LTDANDA 209107—Jul 20, 2018
CETIRIZINE HYDROCHLORIDE ALLERGYGRANULESANDA 209274—Dec 22, 2017
CETIRIZINE HYDROCHLORIDE ALLERGYONESOURCE SPECIALTYANDA 205291—Jul 21, 2017
CETIRIZINE HYDROCHLORIDE ALLERGYAPOTEXANDA 207235—Aug 12, 2016
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY×2NOVEL LABS INCANDA 206793—Mar 08, 2016
CETIRIZINE HYDROCHLORIDE ALLERGYPERRIGO R AND DANDA 205490—Sep 02, 2015
CETIRIZINE HYDROCHLORIDE ALLERGY×4AUROBINDO PHARMA LTDANDA 090760—Aug 05, 2015
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY×4JUBILANT GENERICSANDA 091116—Feb 19, 2015
CETIRIZINE HYDROCHLORIDE ALLERGY×4AIPING PHARM INCANDA 202277—Mar 11, 2014
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGYPERRIGO R AND DANDA 204226—Sep 09, 2013
CETIRIZINE HYDROCHLORIDE ALLERGY×2CIPLA LTDANDA 077318—Jul 25, 2013
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY×2TRIS PHARMA INCANDA 090572—Nov 16, 2012
CETIRIZINE HYDROCHLORIDECHARTWELL MOLECULARANDA 078876AAMay 11, 2012
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY×2BAJAJANDA 091327—Oct 17, 2011
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY×4SUN PHARMANDA 090142—Aug 30, 2011
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY×2TAROANDA 201546—May 20, 2011
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY×2CHARTWELL MOLECULARANDA 091130—Apr 22, 2011
CETIRIZINE HYDROCHLORIDE ALLERGY×4MARKSANS PHARMAANDA 078933—Jun 15, 2010
CETIRIZINE HYDROCHLORIDE ALLERGY×4TORRENT PHARMS LLCANDA 079191—Apr 15, 2010
CETIRIZINE HYDROCHLORIDEACTAVIS MID ATLANTICANDA 078617—Feb 02, 2010
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY×2AUROBINDO PHARMAANDA 090750—Feb 02, 2010
CETIRIZINE HYDROCHLORIDE ALLERGY×4AMNEAL PHARMS NYANDA 078780—Jan 21, 2010
CETIRIZINE HYDROCHLORIDEAUROBINDO PHARMA LTDANDA 090751—Dec 16, 2009
CETIRIZINE HYDROCHLORIDEBAJAJANDA 090191AANov 12, 2009
CETIRIZINE HYDROCHLORIDEAMNEAL PHARMSANDA 090766AAOct 07, 2009
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY×2AMNEAL PHARMSANDA 090765—Oct 07, 2009
CETIRIZINE HYDROCHLORIDELANNETT CO INCANDA 078496—Sep 25, 2009
CETIRIZINE HYDROCHLORIDETIME CAP LABSANDA 078757—Aug 28, 2009
CETIRIZINE HYDROCHLORIDE ALLERGY×4UNIQUEANDA 077829—Aug 26, 2009
CETIRIZINE HYDROCHLORIDE ALLERGY×4TAROANDA 078072—Jul 22, 2009
CETIRIZINE HYDROCHLORIDE ALLERGY×4UNICHEMANDA 078680—Jun 26, 2009
CETIRIZINE HYDROCHLORIDEAPOZEAL PHARMSANDA 078870AAApr 27, 2009
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY×2APOZEAL PHARMSANDA 090474—Mar 30, 2009
CETIRIZINE HYDROCHLORIDE ALLERGY×4ORBION PHARMSANDA 078862—Feb 19, 2009
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY×2CYPRESS PHARMANDA 090300—Oct 10, 2008
CETIRIZINE HYDROCHLORIDEBIONPHARMAANDA 078488AAOct 06, 2008
CETIRIZINE HYDROCHLORIDETAROANDA 076601AAJun 20, 2008
CETIRIZINE HYDROCHLORIDEPHARM ASSOCANDA 078412AAJun 18, 2008
CETIRIZINE HYDROCHLORIDERANBAXY LABS LTDANDA 077472—Jun 18, 2008
CETIRIZINE HYDROCHLORIDEPADAGIS USANDA 078398AAJun 17, 2008
CETIRIZINE HYDROCHLORIDETEVA PHARMSANDA 077279—May 27, 2008
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY×2CHARTWELL RXANDA 090378—May 09, 2008
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY×2RANBAXY LABS LTDANDA 090183—Apr 24, 2008
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY×2PHARM ASSOCANDA 090188—Apr 22, 2008
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY×2TAROANDA 090182—Apr 22, 2008
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY×2PERRIGO R AND DANDA 090254—Apr 09, 2008
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY×2SANDOZANDA 078692—Feb 14, 2008
CETIRIZINE HYDROCHLORIDE ALLERGY×4DR REDDYS LABS LTDANDA 078343—Jan 15, 2008
CETIRIZINE HYDROCHLORIDE ALLERGY×4SUN PHARM INDS INCANDA 077631—Jan 11, 2008
CETIRIZINE HYDROCHLORIDE ALLERGY×2GLENMARK PHARMSANDA 078427—Dec 28, 2007
CETIRIZINE HYDROCHLORIDE ALLERGY×2HERITAGE PHARMAANDA 078615—Dec 28, 2007
CETIRIZINE HYDROCHLORIDE ALLERGY×2APOTEX INCANDA 078317—Dec 27, 2007
CETIRIZINE HYDROCHLORIDE ALLERGY×2CONTRACT PHARMACALANDA 076047—Dec 27, 2007
CETIRIZINE HYDROCHLORIDE ALLERGY×4MYLANANDA 076677—Dec 27, 2007
CETIRIZINE HYDROCHLORIDE ALLERGY×4PERRIGO R AND DANDA 078336—Dec 27, 2007
CETIRIZINE HYDROCHLORIDE ALLERGY×2PLD ACQUISITIONSANDA 077946—Dec 27, 2007
CETIRIZINE HYDROCHLORIDE ALLERGY×4SUN PHARM INDS INCANDA 077499—Dec 27, 2007
CETIRIZINE HYDROCHLORIDE ALLERGY×4SUN PHARM INDS LTDANDA 077498—Dec 27, 2007

Listed patents (11)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9180090Feb 11, 2030in 3 yr 8 mo
U-2635
8513259Feb 11, 2030in 3 yr 8 mo
U-2636
9119771Feb 11, 2030in 3 yr 8 mo
U-2635
8314083Feb 28, 2030in 3 yr 9 mo
U-2634
8263581Feb 28, 2030in 3 yr 9 mo
U-2635
9993471Mar 15, 2030in 3 yr 10 mo
U-1680
8829005Mar 15, 2030in 3 yr 10 mo
U-1680
9750684Mar 15, 2030in 3 yr 10 mo
Product
8829005*PEDSep 15, 2030in 4 yr 4 mo
9254286Jul 09, 2032in 6 yr 2 mo
Product
9254286*PEDJan 09, 2033in 6 yr 8 mo

Cetirizine hydrochloride — frequently asked questions

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

Agent CTA Background

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