DICLEGIS Drug Patent Profile

When do Diclegis patents expire, and what generic alternatives are available?

Diclegis is a drug marketed by Duchesnay and is included in one NDA.

The generic ingredient in DICLEGIS is doxylamine succinate; pyridoxine hydrochloride. There are fourteen drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the doxylamine succinate; pyridoxine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Diclegis

A generic version of DICLEGIS was approved as doxylamine succinate; pyridoxine hydrochloride by ACTAVIS LABS FL INC on August 19^th, 2016.

Summary for DICLEGIS

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	2
Patent Applications:	8
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for DICLEGIS
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DICLEGIS
What excipients (inactive ingredients) are in DICLEGIS?	DICLEGIS excipients list
DailyMed Link:	DICLEGIS at DailyMed

See drug prices for DICLEGIS

See drug sales revenues for DICLEGIS

Recent Clinical Trials for DICLEGIS

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Grünenthal GmbH	Phase 1
Grünenthal, S.A.	Phase 1
Duchesnay Inc.	Phase 4

See all DICLEGIS clinical trials

Pharmacology for DICLEGIS

Ingredient-type	Analogs/Derivatives Vitamin B 6
Drug Class	Antihistamine Vitamin B6 Analog
Mechanism of Action	Histamine Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for DICLEGIS

R06AA	Aminoalkyl ethers
R06A	ANTIHISTAMINES FOR SYSTEMIC USE
R06	ANTIHISTAMINES FOR SYSTEMIC USE
R	Respiratory system

Paragraph IV (Patent) Challenges for DICLEGIS

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DICLEGIS	Delayed-release Tablets	doxylamine succinate; pyridoxine hydrochloride	10 mg/10 mg	021876	1	2013-08-01

US Patents and Regulatory Information for DICLEGIS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Duchesnay	DICLEGIS	doxylamine succinate; pyridoxine hydrochloride	TABLET, DELAYED RELEASE;ORAL	021876-001	Apr 8, 2013	AB	RX	Yes	Yes

Expired US Patents for DICLEGIS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Duchesnay	DICLEGIS	doxylamine succinate; pyridoxine hydrochloride	TABLET, DELAYED RELEASE;ORAL	021876-001	Apr 8, 2013
Duchesnay	DICLEGIS	doxylamine succinate; pyridoxine hydrochloride	TABLET, DELAYED RELEASE;ORAL	021876-001	Apr 8, 2013

International Patents for DICLEGIS

See the table below for patents covering DICLEGIS around the world.

Country	Patent Number	Title	Estimated Expiration
Norway	332190
Sweden	526307	Sammansättning med pyridoxyn-HCL och doxylaminsuccinat (New rapid onset formulation for treating nausea and vomiting comprises enterically coated pyridoxine HCl, doxylamine succinate and a disintegrating agent)
Ireland	20030484	Pharmaceutical dosage form bearing pregnancy-friendly indicia
France	2826277	FORMULATION A DELAI D'ACTION RAPIDE
China	1229112
Greece	1004641	ΜΟΡΦΗΑΦΑΡΜΑΚΕΥΤΙΚΗΣΑΔΟΣΟΛΟΓΙΑΣΑΠΟΥΑΦΕΡΕΙΑΦΙΛΙΚΕΣΑΠΡΟΣΑΤΗΝΑΚΥΗΣΗΑΕΝΔΕΙΞΕΙΣΑΑ (PHARMACEUTICAL DOASAGE FORM BEARING PREGNANCY-FRIENDLY INDICIA)
Canada	2350195	PREPARATION A DELAI D'ACTION RAPIDE DE CHLORHYDRATE DE PYRIDOXINE ET DE DOXYLAMINE SUCCINATE (RAPID ONSET FORMULATION OF PYRIDOXINE HYDROCHLORIDE AND DOXYLAMINE SUCCINATE)