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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Escher Fund for Autism - Citizen Petition FDA-2013-P-0522 · 6 docket documents Jill Escher, filing on behalf of the Escher Fund for Autism, submitted this citizen petition under 21 C.F.R. 10.30 on April 26, 2013, requesting that the FDA revoke its March 2013 approval of Diclegis (doxylamine succinate and pyridoxine hydrochloride) as a Category A pregnancy drug pending fetal ge	505(q)	2013-05-17	Denied	—

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

Clinical Trials

2 trials from ClinicalTrials.gov, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
The Efficacy Of Diclectin® For Nausea And Vomiting Of Pregnancy NCT00614445	Phase 3	Completed	Duchesnay Inc.	280	2008-01 → 2009-12
A Study to Investigate Differences in the Extent and Rate of Absorption of Doxylamine/Pyridoxine From 2 Different Products Under Fasting Conditions NCT03905564	Phase 1	Withdrawn	Grünenthal GmbH	—	2019-06 → 2020-06

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs (1 brand, 1 generic)

Highest NADAC/Unit

$1.68

per ea

Lowest NADAC/Unit

$1.25

per ea

Brand NDCs

Generic NDCs

Avg Brand: $1.68

Avg Generic: $1.25

26% less

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
55494010010DICLEGIS DR 10-10 MG TABLET	$1.68	EA	Brand	$1.25	2026-04-01
70505010010DOXYLAMINE-PYRIDOXINE 10-10 MG	$1.25	EA	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (2 FSS)

Lowest Price

$14.54

Highest Price

$192.32

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
55494-0100-10DICLEGIS	$192.32	FSS	Duchesnay USA, Inc.	06/30/2027
70505-0100-10DOXYLAMINE 10MG/PYRIDOXINE HCL 10MG TAB,EC	$14.54	FSS	Analog Pharma, Inc.	09/28/2030

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Diclegis (2024)

Total Spending

$8K

Total Claims

Beneficiaries

Avg Cost/Unit

$3.58

Spending Trend

$187K(2019)→$61K(2020)→$25K(2021)→$19K(2022)→$17K(2023)→$8K(2024)

YoY Change:-26.7%

5yr CAGR:-13.2%

Source: CMS Medicare Part D Spending by Drug (2024). 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.