Viewing data from:

CLARITIN-D

NDA

LORATADINE; PSEUDOEPHEDRINE SULFATE | N019670 | 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

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

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Blue Cross of California - Citizen Petition FDA-1998-P-0254 · 3 docket documents Blue Cross of California, filed under 21 CFR 10.30, petitioned the FDA to convert six prescription antihistamine medications—Allegra, Allegra-D, Claritin, Claritin-D, Claritin-D 24 Hour, and Zyrtec—to over-the-counter status, arguing these selective antihistamines are safer than currently available	Other	2009-04-30	Open	—

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

Clinical Trials

7 trials from ClinicalTrials.gov, 6 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Bioequivalnce Study of Loratadine / Pseudoephedrine Sulfate 10/ 240 mg Extended-Release Tablets Under Fasting Conditions NCT00837915	N/A	Completed	Ranbaxy Laboratories Limited	40	2002-06 → 2002-11
Bioequivalence Study of Loratadine / Pseudoephedrine Sulfate 10/ 240 mg Extended-Release Tablets Under Fed Conditions NCT00845546	N/A	Completed	Ranbaxy Laboratories Limited	40	2002-06 → 2002-11
A Study to Evaluate Changes in Nasal Airflow of Loratadine/Pseudoephedrine Tablet and Fluticasone Propionate Nasal Spray in Subjects Following Allergen Exposure NCT03443843	Phase 4	Completed	Bayer	82	2018-02-21 → 2018-05-11
Effectiveness of Two Preparations of Loratadine + Pseudoephedrine in Patients With Perennial Allergic Rhinitis.NCT01228630	Phase 3	Completed	Azidus Brasil	156	2011-08 → 2012-05
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 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
Clinical Trial Of The Effectiveness Of The Product Cloratadd D (Loratadine + Pseudoephedrine Sulfate) Produced By The Laboratory EMS S/A, Compared To The Drug Claritin D Produced By Schering-Plough S/A, In Patients With Allergic Rhinitis NCT01055756	Phase 3	Withdrawn	Azidus Brasil	—	2010-01 → 2010-06

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

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Nov 14, 2023	SUPPL -36	View Letter (PDF)
Aug 3, 2018	SUPPL -34	View Letter (PDF)
Nov 27, 2015	SUPPL -32	View Letter (PDF)
Feb 17, 2010	SUPPL -22	View Letter (PDF)
Apr 27, 2009	SUPPL -20	View Letter (PDF)
Aug 2, 2004	SUPPL -19	View Letter (PDF)
Nov 27, 2002	SUPPL -18	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#002 — 5MG;120MG

RLD

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Nov 27, 2002

No patent or exclusivity listings for this strength.