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CLARITIN REDITABS

NDA

LORATADINE | N020704 | BAYER HEALTHCARE LLC

2 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 (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Strides, Inc. FDA-2006-P-0087 · 4 docket documents Strides, Inc. filed this citizen petition requesting that the FDA take action regarding loratadine products, specifically concerning the Orange Book listings and regulatory status of various loratadine formulations including tablets, syrups, and suspensions marketed under names such as Claritin and	Other	2009-04-20	Denied	Strides, Inc.
Citizen Petition from Lachman Consultant Services, Inc. FDA-2007-P-0015 · 4 docket documents Lachman Consultant Services, Inc. filed this citizen petition on behalf of MonoSolRx, LLC pursuant to section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act, requesting that the FDA declare Loratadine Orally-Dissolving Strips in 5 mg and 10 mg strengths suitable for consideration in an abbr	Other	2008-04-11	Open	Lachman Consultant Services, Inc.

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

Clinical Trials

56 trials from ClinicalTrials.gov — 1 recruiting, 48 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Loratadine for the Reduction of G-CSF Induced Bone Pain in Patients With Multiple Myeloma Undergoing Stem Cell Mobilization NCT04211259	Early Phase 1	Recruiting	Rutgers, The State University of New Jersey	70	2022-04-18 → 2027-06-30
Montelukast in Seasonal Allergic Rhinitis - Spring 2001 Study (0476-235)NCT00972738	Phase 3	Completed	Organon and Co	1,214	2001-04 → 2001-07
Study of Efficacy and Safety of Ginger Extract Compared With Loratadine for Treatment of Allergic Rhinitis NCT02576808	Phase 2	Completed	Thai Traditional Medical Knowledge Fund	80	2015-10 → 2017-10
A Phase I Study to Assess the Safety and Tolerability of Topical CRx-197 Formulations in Healthy Volunteers NCT00721331	Phase 1	Completed	Zalicus	20	2008-07 → 2008-09
Quality of Life in Patients With Allergic Rhinitis: Clinical Trial With Bilastine or Loratadine NCT02513290	Phase 4	Completed	Universidade do Sul de Santa Catarina	73	2013-08 → 2014-08
Bioequivalence Study on Loratadine Orally Disintegrating Tablets 10 mg Under Fasting Conditions NCT00776217	N/A	Completed	Ranbaxy Laboratories Limited	80	2006-06 → 2006-09
A Study to Evaluate the Safety of Combination Montelukast/Loratadine in Mexican Participants With Allergic Rhinitis (MK-0476A-484)NCT01673620	Phase 3	Completed	Organon and Co	69	2012-07-04 → 2012-10-10
A Manufacturing Transfer Study Comparing the Bioequivalence of a Single Oral Dose of Claritin-D 12-Hour Extended Release Tablet From 2 Different Manufactuers Under Fed Conditions in Healthy Adult Subjects NCT03517943	Phase 1	Completed	Bayer	29	2018-04-24 → 2018-08-30
Efficacy and Safety of Grass Sublingual Tablet in Adults (P05238 AM3)(COMPLETED)NCT00562159	Phase 3	Completed	ALK-Abelló A/S	439	2007-11 → 2009-09
Efficacy & Safety of Loratadine-Betamethasone Oral Solution for Treatment of Severe Perennial Allergic Rhinitis in Children (Study P03428)NCT00963573	Phase 4	Completed	Merck Sharp & Dohme LLC	100	2003-09 → 2006-11

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

API Supply Chain12 active DMFs12 inactive

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

QUIMICA SINTETICA SALORATADINE

DMF 118031995

MOREPEN LABORATORIES LTDLORATADINE

DMF 126501997

ROLABO OUTSOURCING SLLORATADINE USP

DMF 141551999

SUN PHARMACEUTICAL INDUSTRIES LTDLORATADINE USP

DMF 152512001

CADILA PHARMACEUTICALS LTDLORATADINE USP POWDER

DMF 175822004

ZYDUS LIFESCIENCES LTDLORATADINE USP

DMF 187022005

ALIVUS LIFE SCIENCES LTDLORATADINE USP

DMF 194002006

VASUDHA PHARMA CHEM LTDLORATADINE USP

DMF 203672007

MATRIX PHARMACORP PRIVATE LTDLORATADINE USP (LCP)

DMF 204472007

MOREPEN LABORATORIES LTDLORATADINE (PROCESS 2) U.S.P.

DMF 206692007

SOLARA ACTIVE PHARMA SCIENCES LTDLORATADINE USP

DMF 284112014

VASUDHA PHARMA CHEM LTDLORATADINE USP (PROCESS-II)

DMF 348222020

MSD INTERNATIONAL GMBHInactiveLORATADINE

DMF 66261986

QUIMICA SINTETICA SAInactiveLORATADINE

DMF 98301992

MSD INTERNATIONAL GMBHInactiveLORATADINE

DMF 130321998

INKE SAInactiveLORATADINE

DMF 138111998

MEDICHEM SAInactiveLORATADINE

DMF 138421998

CADILA HEALTHCARE LTDInactiveLORATADINE

DMF 169702003

MYLAN LABORATORIES LTDInactiveLORATADINE USP (LDP)

DMF 172872004

DIVIS LABORATORIES LTDInactiveLORATADINE USP

DMF 178102004

SUZHOU WANQING PHARMACEUTICALS CO LTDInactiveLORATADINE

DMF 180582005

CATALENT PHARMA SOLUTIONS LLCInactiveLORATADINE SOFTGELS (10 MG)

DMF 186962005

ZHEJIANG WEPON PHARMACEUTICAL CO LTDInactiveLORATADINE

DMF 197402006

AARTI DRUGS LTDInactiveLORATADINE

DMF 204962007

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

Approval Letters

14 letters from Drugs@FDA

Date	Submission	Document
May 26, 2023	SUPPL -41	View Letter (PDF)
Jan 13, 2021	SUPPL -37	View Letter (PDF)
May 8, 2019	SUPPL -35	View Letter (PDF)
Mar 1, 2019	SUPPL -34	View Letter (PDF)
Jul 25, 2018	SUPPL -33	View Letter (PDF)
May 19, 2017	SUPPL -32	View Letter (PDF)
Nov 8, 2016	SUPPL -29	View Letter (PDF)
Nov 27, 2015	SUPPL -28	View Letter (PDF)
Jul 24, 2014	SUPPL -27	View Letter (PDF)
Feb 3, 2009	SUPPL -21	View Letter (PDF)
Oct 23, 2008	SUPPL -20	View Letter (PDF)
Jan 30, 2006	SUPPL -14	View Letter (PDF)
Nov 25, 2003	SUPPL -9	View Letter (PDF)
Nov 27, 2002	SUPPL -8	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#003 — 10MG

RLD

0 patents0 exclusivities▾

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: Nov 19, 2003

#002 — 10MG

RLD

0 patents0 exclusivities▴

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: Nov 27, 2002

No patent or exclusivity listings for this strength.