Viewing data from:

CLARINEX-D 12 HOUR

NDA

DESLORATADINE; PSEUDOEPHEDRINE SULFATE | N021313 | ORGANON 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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Clarinex-D 12 Hour (2023)

Total Spending

$764K

Total Claims

1,260

Beneficiaries

380

Avg Cost/Unit

$5.46

Spending Trend

$127K(2021)→$690K(2022)→$764K(2023)

YoY Change:+8.1%

5yr CAGR:+7.6%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Mar 18, 2019	SUPPL -12	View Letter (PDF)
Apr 23, 2018	SUPPL -10	View Letter (PDF)
Feb 8, 2018	SUPPL -9	View Letter (PDF)
Mar 10, 2014	SUPPL -5	View Letter (PDF)
Jan 5, 2010	SUPPL -2	View Letter (PDF)
Jul 24, 2007	SUPPL -1	View Letter (PDF)
Feb 8, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 2.5MG;120MG

RLD

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Feb 1, 2006

No patent or exclusivity listings for this strength.