Viewing data from:

DICLEGIS

NDA

DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE | N021876 | DUCHESNAY INC

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 Diclegis (2023)

Total Spending

$17K

Total Claims

Beneficiaries

Avg Cost/Unit

$4.89

Spending Trend

$187K(2019)→$61K(2020)→$25K(2021)→$19K(2022)→$17K(2023)

YoY Change:-2.3%

5yr CAGR:-8.5%

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Nov 1, 2022	SUPPL -16	View Letter (PDF)
Jun 21, 2018	SUPPL -13	View Letter (PDF)
Dec 17, 2014	SUPPL -6	View Letter (PDF)
Apr 10, 2013	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10MG;10MG

RLDAB

0 patents0 exclusivities▴

TABLET, DELAYED RELEASE;ORAL | Approved: Apr 8, 2013

No patent or exclusivity listings for this strength.