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CLARITIN

NDA

LORATADINE | N021952 | BAYER HEALTHCARE LLC

1 strength0 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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

59 trials from ClinicalTrials.gov — 4 recruiting, 48 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Evaluating Premedication Regimens (Methylprednisolone vs Dexamethasone-based) for the Prevention of Systemic and Injection Site Reactions to Motixafortide in Patients With Multiple Myeloma Undergoing Stem Cell Mobilization, PARADE Trial NCT07101445	Phase 4	Recruiting	Emory University	94	2025-09-24 → 2027-12-31
Comparing Diosmin-Hesperidin and Loratadine to Prevent Bone Pain From G-CSF in Patients With Blood Cancers NCT07300735	N/A	Recruiting	Alexandria University	88	2025-03-01 → 2027-07
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
Optimizing Ancillary Therapies With Immune Checkpoint Inhibitors for Solid Tumors (OAT ICI)NCT07661459	Phase 2	Recruiting	Val Adams	98	2026-06-26 → 2027-07-31
Montelukast in Seasonal Allergic Rhinitis - Spring 2001 Study (0476-235)NCT00972738	Phase 3	Completed	Organon and Co	1,214	2001-04 → 2001-07
Montelukast in Seasonal Allergic Rhinitis - Fall 1999 Study (0476A-117)NCT00963599	Phase 3	Completed	Organon and Co	907	1999-09 → 1999-11
Iron Repletion in Chronic Cough and Iron Deficiency NCT01507792	N/A	Completed	University of Turin, Italy	22	2002-01 → 2011-01
A Manufacturing Transfer Study Comparing the Bioequivalence of a Single Oral Dose of Claritin-D 12-Hour Extended Release Tablet From 2 Different Manufacturers Under Fasted Conditions in Healthy Adult Subjects NCT03517930	Phase 1	Completed	Bayer	52	2018-04-17 → 2018-07-20
A Study to Assess the Relative Bioavailability of Xisimin (Loratadine) Tablets Under Fasting and Fed Conditions in Healthy Participants Compared to Clarityne Tablets NCT03151720	Phase 1	Completed	Xian-Janssen Pharmaceutical Ltd.	28	2017-06-01 → 2017-07-08
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

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

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

10 letters from Drugs@FDA

Date	Submission	Document
Apr 27, 2026	SUPPL -24	View Letter (PDF)
Jun 1, 2023	SUPPL -22	View Letter (PDF)
Dec 31, 2018	SUPPL -18	View Letter (PDF)
Jul 23, 2018	SUPPL -17	View Letter (PDF)
Jun 27, 2018	SUPPL -16	View Letter (PDF)
Jun 5, 2018	SUPPL -15	View Letter (PDF)
Apr 23, 2018	SUPPL -14	View Letter (PDF)
Dec 10, 2015	SUPPL -12	View Letter (PDF)
Apr 10, 2009	SUPPL -3	View Letter (PDF)
Jun 19, 2008	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10MG

RLD

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Jun 16, 2008

No patent or exclusivity listings for this strength.