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FDA Orange Book · active-ingredient family

Fexofenadine hydrochloride

Fexofenadine hydrochloride is approved as 5 brand and 19 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:CHILDREN'S ALLEGRA ALLERGY · NDA 201373

5

Brand (NDA)

19

Generics (ANDA)

1

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule, suspension, tablet, tablet, orally disintegrating

ProductApplicantApplicationTEApproved
CHILDREN'S ALLEGRA ALLERGYRLD×2CHATTEM SANOFINDA 201373—Jan 24, 2011
CHILDREN'S ALLEGRA ALLERGYRLD×2CHATTEM SANOFINDA 021909—Jan 24, 2011
ALLEGRA ALLERGYRLD×6CHATTEM SANOFINDA 020872—Jan 24, 2011
ALLEGRARLDCHATTEM SANOFINDA 021963—Oct 16, 2006
ALLEGRACHATTEM SANOFINDA 020625—Jul 25, 1996

Generic (ANDA) products (19)

ProductApplicantApplicationTEApproved
FEXOFENADINE HYDROCHLORIDE×2CONTRACT PHARMACALANDA 219032—Feb 28, 2025
FEXOFENADINE HYDROCHLORIDEAUROBINDO PHARMA LTDANDA 213466—May 23, 2023
FEXOFENADINE HYDROCHLORIDE×2L PERRIGO COANDA 212971—Feb 24, 2020
FEXOFENADINE HYDROCHLORIDE ALLERGY×2GRANULESANDA 211075—Oct 18, 2019
FEXOFENADINE HYDROCHLORIDE ALLERGYUNIQUEANDA 210137—Aug 13, 2018
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY×2TAROANDA 208123—Nov 09, 2017
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY×3HETERO LABS LTD VANDA 204097—Aug 19, 2016
FEXOFENADINE HYDROCHLORIDE ALLERGY×4SCIEGEN PHARMSANDA 204507—Sep 16, 2015
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY×3AUROBINDO PHARMA LTDANDA 202039—Nov 19, 2014
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY×2P AND LANDA 203330—Nov 18, 2014
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY×2DR REDDYS LABS LTDANDA 202978—Jan 18, 2013
FEXOFENADINE HYDROCHLORIDEP AND LANDA 201311—Jul 25, 2012
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY×6TIME CAP LABSANDA 079112—Feb 08, 2012
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY×6SUN PHARM INDSANDA 091567—Feb 06, 2012
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY×9RISINGANDA 077081—Jul 21, 2011
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY×8TEVAANDA 076447—Apr 13, 2011
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY×9DR REDDYS LABS LTDANDA 076502—Apr 12, 2011
FEXOFENADINE HYDROCHLORIDE×3BARRANDA 076191—Aug 31, 2005
FEXOFENADINE HYDROCHLORIDEBARRANDA 076169—Jul 13, 2005

Listed patents (1)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8933097Aug 02, 2030in 4 yr 2 mo
Product

Fexofenadine 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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