DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE - Generic Drug Details

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What are the generic drug sources for doxylamine succinate; pyridoxine hydrochloride and what is the scope of freedom to operate?

Doxylamine succinate; pyridoxine hydrochloride is the generic ingredient in four branded drugs marketed by Duchesnay, Actavis Labs Fl Inc, Bionpharma, Endo Operations, Mylan Pharms Inc, and Sanofi Aventis Us, and is included in eight NDAs. There are four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Doxylamine succinate; pyridoxine hydrochloride has sixty-four patent family members in thirty-one countries.

Seven suppliers are listed for this compound.

Summary for DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE

International Patents:	64
US Patents:	4
Tradenames:	4
Applicants:	6
NDAs:	8
Finished Product Suppliers / Packagers:	7
Clinical Trials:	4
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE
DailyMed Link:	DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE

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

Sponsor	Phase
Hegang Maternal and Child Health Hospital	Phase 3
Shuangyashan Maternal and Child Health Hospital	Phase 3
Luoyang Hospital of TCM	Phase 3

See all DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE clinical trials

Pharmacology for DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE

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 DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE

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

Paragraph IV (Patent) Challenges for DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BONJESTA	Extended-release Tablets	doxylamine succinate; pyridoxine hydrochloride	20 mg/20 mg	209661	1	2018-08-28
DICLEGIS	Delayed-release Tablets	doxylamine succinate; pyridoxine hydrochloride	10 mg/10 mg	021876	1	2013-08-01

US Patents and Regulatory Information for DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Actavis Labs Fl Inc	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	doxylamine succinate; pyridoxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212472-001	Mar 1, 2022		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Endo Operations	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	doxylamine succinate; pyridoxine hydrochloride	TABLET, DELAYED RELEASE;ORAL	208518-001	Dec 6, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Duchesnay	BONJESTA	doxylamine succinate; pyridoxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209661-001	Nov 7, 2016		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Sanofi Aventis Us	BENDECTIN	doxylamine succinate; pyridoxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	010598-002	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Actavis Labs Fl Inc	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	doxylamine succinate; pyridoxine hydrochloride	TABLET, DELAYED RELEASE;ORAL	205811-001	Aug 19, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Duchesnay	BONJESTA	doxylamine succinate; pyridoxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209661-001	Nov 7, 2016		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Bionpharma	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	doxylamine succinate; pyridoxine hydrochloride	TABLET, DELAYED RELEASE;ORAL	217000-001	Aug 4, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE

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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	⤷ Sign Up	⤷ Sign Up
Duchesnay	BONJESTA	doxylamine succinate; pyridoxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209661-001	Nov 7, 2016	⤷ Sign Up	⤷ Sign Up
Duchesnay	DICLEGIS	doxylamine succinate; pyridoxine hydrochloride	TABLET, DELAYED RELEASE;ORAL	021876-001	Apr 8, 2013	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE

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Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	201790477	СОСТАВ С МНОГОРЕЖИМНЫМ ВЫСВОБОЖДЕНИЕМ, СОДЕРЖАЩИЙ ДОКСИЛАМИН И ПИРИДОКСИН И/ИЛИ ИХ МЕТАБОЛИТЫ ИЛИ СОЛИ	⤷ Sign Up
Argentina	101728	FORMULACIÓN DE LIBERACIÓN PLURIMODAL DE DOXILAMINA Y PIRIDOXINA Y/O METABOLITOS O SALES DE LAS MISMAS	⤷ Sign Up
Poland	3185856		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2013123595		⤷ Sign Up
Taiwan	201613584	Plurimodal release formulation of doxylamine and pyridoxine and/or metabolites or salts thereof	⤷ Sign Up
Mexico	2017002495	FORMULACION DE LIBERACION PLURIMODAL DE DOXILAMINA Y PIRIDOXINA Y/O METABOLITOS O SALES DE LAS MISMAS. (PLURIMODAL RELEASE FORMULATION OF DOXYLAMINE AND PYRIDOXINE AND/OR METABOLITES OR SALTS THEREOF.)	⤷ Sign Up
Malaysia	196073	PLURIMODAL RELEASE FORMULATION OF DOXYLAMINE AND PYRIDOXINE AND/OR METABOLITES OR SALTS THEREOF	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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