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CHILDREN'S ALLEGRA ALLERGY

NDA

FEXOFENADINE HYDROCHLORIDE | N020872 | CHATTEM INC DBA SANOFI CONSUMER HEALTHCARE

6 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Lupin Pharmaceuticals, Inc. FDA-2006-P-0458 · 6 docket documents Lupin Pharmaceuticals, Inc. filed this suitability petition on September 28, 2006 pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act and 21 CFR 314.93, requesting that the FDA declare Fexofenadine Hydrochloride for Oral Suspension in 30 mg/5 mL and 60 mg/5 mL strengths suita	Other	2008-07-22	Withdrawn	Lupin Pharmaceuticals, Inc.
Citizen Petition from Greenberg Traurig LLP FDA-2007-P-0056 · 5 docket documents Greenberg Traurig LLP filed this citizen petition on March 12, 2007 requesting that the FDA switch Allegra (fexofenadine hydrochloride) in multiple formulations under NDAs 20625, 20872, and 21963, Allegra D under NDAs 20786 and 21704, and Zyrtec (cetirizine hydrochloride) under NDAs 19835, 21621, an	Other	2008-04-11	Withdrawn	Greenberg Traurig LLP

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

60 trials from ClinicalTrials.gov — 1 recruiting, 51 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
: Vascular Function in Health and Disease NCT02966665	Phase 1	Recruiting	Russell Richardson	420	2008-09 → 2026-08
A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Two-Way Crossover Study Designed to Evaluate the Efficacy of Fexofenadine HCl 180 mg for Preventing and Controlling Cat Allergy Symptoms NCT00637884	Phase 4	Completed	Sanofi	70	2003-11 → 2004-02
Evaluation of the Inhibitory Effect of 5 Anti-Histamines in Urticaria NCT01940393	Phase 4	Completed	Grupo de Alergología Clínica y Experimental	150	2013-08 → 2014-01
A Drug Interaction Study Between Danicopan and Midazolam, Fexofenadine, and Mycophenolate Mofetil in Healthy Participants NCT03108274	Phase 1	Completed	Alexion Pharmaceuticals, Inc.	35	2017-04-18 → 2017-06-16
Efficacy and Safety of Fexofenadine in Mild to Moderate Persistent Asthma NCT00044824	Phase 3	Completed	Sanofi	1,000	2002-02 → 2003-10
Single Center, Randomized, Double-Blind,Crossover Study Comparing Effects Of Single-Dose Fexofenadine HCl 180 mg, Cetirizine 10 mg, and Placebo on Cognitive Performance in Naval Flight Personnel NCT00637455	Phase 4	Completed	Sanofi	72	2003-09 → 2005-01
Fexofenadine Study On Filipino Children for The Relief of Perennial And Intermittent Allergic Rhinitis NCT00741897	Phase 4	Completed	Sanofi	264	2002-03
Bioequivalence Study of Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets of Dr. Reddy's and Allegra D 24 Hour ER Tablets Under Fasting Conditions NCT01133470	Phase 1	Completed	Dr. Reddy's Laboratories Limited	54	2007-02 → 2007-04
Single-Center, Double-Blind, Randomized , Parallel Study Comparing Onset of Action, Efficacy & Safety of a Single-Dose of Fexofenadine HCl 180 mg vs Montelukast Na 10 mg & Placebo in Treating Seasonal Allergic Rhinitis Subjects in an Allergen Exposure Unit NCT00637611	Phase 4	Completed	Sanofi	1,010	2003-02 → 2003-04
Bioequivalence Study of Dr.Reddy's Fexofenadine Hydrochloride 180 mg Tablets Under Fasting Conditions NCT01066754	Phase 1	Completed	Dr. Reddy's Laboratories Limited	44	2002-04 → 2002-05

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain16 active DMFs8 inactive

14 active API suppliers hold Drug Master Files for this ingredient.

DR REDDYS LABORATORIES LTDFEXOFENADINE HYDROCHLORIDE

DMF 157572001

WOCKHARDT LTDFEXOFENADINE HYDROCHLORIDE

DMF 198162006

MATRIX PHARMACORP PRIVATE LTDFEXOFENADINE HYDROCHLORIDE USP

DMF 223682008

SYNTHIMED LABS PRIVATE LTDFEXOFENADINE HYDROCHLORIDE USP

DMF 245972011

HETERO DRUGS LTDFEXOFENADINE HYDROCHLORIDE

DMF 256372011

JUBILANT BIOSYS LTDFEXOFENADINE HYDROCHLORIDE

DMF 267182013

DIPHARMA FRANCIS SRLFEXOFENADINE HYDROCHLORIDE USP FORM A

DMF 282872014

DIPHARMA FRANCIS SRLFEXOFENADINE HYDROCHLORIDE USP FORM l

DMF 286122014

APITORIA PHARMA PRIVATE LTDFEXOFENADINE HYDROCHLORIDE USP

DMF 289952015

PERRIGO API LTDFEXOFENADINE HYDROCHLORIDE

DMF 294452015

VASUDHA PHARMA CHEM LTDFEXOFENADINE HYDROCHLORIDE USP

DMF 297402015

GRANULES INDIA LTDFEXOFENADINE HYDROCHLORIDE, USP

DMF 306042016

MOREPEN LABORATORIES LTDFEXOFENADINE HYDROCHLORIDE USP

DMF 306922016

DR REDDYS LABORATORIES LTDFEXOFENADINE HYDROCHLORIDE USP (FORM-I)

DMF 346452020

THINQ PHARMA-CRO LTDFEXOFENADINE HYDROCHLORIDE USP

DMF 362552021

CHEMECA DRUGS PRIVATE LTDFEXOFENADINE HYDROCHLORIDE USP

DMF 365542021

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveFEXOFENADINE HYDROCHLORIDE USP

DMF 154192001

FARMHISPANIA SAInactiveFEXOFENADINE HYDROCHLORIDE

DMF 155212001

WOCKHARDT LTDInactiveFEXOFENADINE HYDROCHLORIDE

DMF 159772002

DIPHARMA FRANCIS SRLInactiveFEXOFENADINE HYDROCHLORIDE USP

DMF 160292002

CIPLA LTDInactiveFEXOFENADINE HYDROCHLORIDE USP

DMF 188002005

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveFEXOFENADINE HYDROCHLORIDE

DMF 189492005

SANOFI AVENTIS DEUTSCHLAND GMBHInactiveFEXOFENADINE HYDROCHLORIDE (MDL 16455 A)

DMF 233602009

RA CHEM PHARMA LTDInactiveFEXOFENADINE HYDROCHLORIDE USP

DMF 297352015

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

17 letters from Drugs@FDA

Date	Submission	Document
Aug 2, 2023	SUPPL -47	View Letter (PDF)
Oct 14, 2021	SUPPL -46	View Letter (PDF)
May 12, 2016	SUPPL -38	View Letter (PDF)
Sep 16, 2014	SUPPL -32	View Letter (PDF)
Apr 17, 2014	SUPPL -31	View Letter (PDF)
Aug 27, 2012	SUPPL -29	View Letter (PDF)
Feb 27, 2012	SUPPL -25	View Letter (PDF)
Jan 27, 2011	SUPPL -23	View Letter (PDF)
Jun 30, 2008	SUPPL -18	View Letter (PDF)
Oct 19, 2005	SUPPL -15	View Letter (PDF)
Jun 8, 2003	SUPPL -3	View Letter (PDF)
Jun 8, 2003	SUPPL -11	View Letter (PDF)
Oct 29, 2001	SUPPL -4	View Letter (PDF)
Oct 29, 2001	SUPPL -2	View Letter (PDF)
Oct 29, 2001	SUPPL -1	View Letter (PDF)
Jul 11, 2001	SUPPL -7	View Letter (PDF)
Feb 25, 2000	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (6)

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#007 — 60MG

RLD

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