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FDA Orange Book · active-ingredient family

Loratadine

Loratadine is approved as 9 brand and 38 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:CLARITIN · NDA 021952

9

Brand (NDA)

38

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

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

ProductApplicantApplicationTEApproved
CLARITINRLDBAYER HEALTHCARE LLCNDA 021952—Jun 16, 2008
CLARITIN REDITABSRLDBAYER HEALTHCARE LLCNDA 021993—Dec 12, 2006
CHILDREN'S CLARITINRLD×2BAYER HEALTHCARE LLCNDA 021891—Aug 23, 2006
LORATADINERLDSUN PHARMA CANADANDA 021734—Oct 04, 2005
CLARITIN HIVES RELIEF REDITABRLD×2BAYER HEALTHCARE LLCNDA 020704—Nov 19, 2003
CLARITINRLD×2BAYER HEALTHCARE LLCNDA 020641—Nov 27, 2002
CLARITINRLD×2BAYER HEALTHCARE LLCNDA 019658—Nov 27, 2002
LORATADINEPERRIGONDA 021512—Jun 24, 2004
ALAVERTFDN CONSUMERNDA 021375—Dec 19, 2002

Generic (ANDA) products (38)

ProductApplicantApplicationTEApproved
LORATADINECATALENT PHARMAANDA 215127—Feb 28, 2025
LORATADINEMARKSANS PHARMAANDA 219223—Nov 21, 2024
LORATADINEHETERO LABS LTD VANDA 211718—Jul 28, 2023
LORATADINEAUROBINDO PHARMAANDA 211900—Mar 24, 2023
LORATADINEHETERO LABS LTD IIIANDA 210409—May 07, 2021
LORATADINEUNIQUE PHARMANDA 214684—Jan 07, 2021
LORATADINEINSTAPILLANDA 213294—Oct 30, 2020
LORATADINEINSTAPILLANDA 212795—Sep 18, 2020
LORATADINERUBICON RESEARCHANDA 214280—Sep 10, 2020
LORATADINEONESOURCE SPECIALTYANDA 211926—Jan 15, 2020
LORATADINEGRANULESANDA 210722—Dec 23, 2019
LORATADINEPERRIGO PHARMA INTLANDA 210033—Jun 12, 2019
LORATADINEANDA REPOSITORYANDA 207569—Mar 12, 2019
LORATADINEBIONPHARMAANDA 202538—Dec 21, 2018
LORATADINEAUROBINDO PHARMA LTDANDA 208931—Jun 29, 2018
LORATADINE×2SUN PHARMANDA 210088—Apr 16, 2018
LORATADINEAUROBINDO PHARMA LTDANDA 208314—Apr 16, 2018
LORATADINEAUROBINDO PHARMA LTDANDA 208477—Apr 11, 2018
LORATADINEMARKSANS PHARMAANDA 206214—Sep 23, 2016
LORATADINETAROANDA 201865—Jul 31, 2015
LORATADINEPHARMOBEDIENTANDA 078447—Aug 12, 2011
LORATADINEPHARMOBEDIENTANDA 075790—Nov 07, 2008
LORATADINE REDIDOSESUN PHARM INDS LTDANDA 077153—Apr 11, 2007
LORATADINELANNETT CO INCANDA 077421—Jun 29, 2006
LORATADINEAPOTEXANDA 076471—Feb 14, 2006
LORATADINEPHARM ASSOCANDA 075565—Oct 05, 2004
LORATADINEPERRIGOANDA 075728—Aug 20, 2004
LORATADINERANBAXY LABS LTDANDA 076529—Aug 20, 2004
LORATADINETAROANDA 076805—Aug 20, 2004
LORATADINEWOCKHARDT BIO AGANDA 075815—Aug 20, 2004
LORATADINEPERRIGOANDA 076301—Jun 25, 2004
LORATADINETEVAANDA 075505—Nov 07, 2003
LORATADINEACTAVIS LABS FL INCANDA 075990—Nov 03, 2003
LORATADINEPERRIGO PHARMA INTLANDA 076011—Sep 29, 2003
LORATADINEMYLANANDA 076154—Aug 20, 2003
LORATADINESUN PHARM INDS LTDANDA 076134—Aug 18, 2003
LORATADINEGLAXOSMITHKLINEANDA 075822—Feb 10, 2003
LORATADINEPLD ACQUISITIONS LLCANDA 075209—Jan 21, 2003

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Loratadine — frequently asked questions

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

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