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Last Updated: April 16, 2024

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 patent protection?

Doxylamine succinate; pyridoxine hydrochloride is the generic ingredient in four branded drugs marketed by Duchesnay, Actavis Labs Fl Inc, Bionpharma, Mylan Pharms Inc, Par Pharm 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
First Affiliated Hospital of Heilongjiang Chinese Medicine University	Phase 3
Ningxia Hui Autonomous Region Hospital of TCM	Phase 3
Jixi Maternal and Child Health Hospital	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

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, DELAYED RELEASE;ORAL	205811-001	Aug 19, 2016	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mylan Pharms Inc	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	doxylamine succinate; pyridoxine hydrochloride	TABLET, DELAYED RELEASE;ORAL	207825-001	Jul 6, 2020	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Duchesnay	BONJESTA	doxylamine succinate; pyridoxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209661-001	Nov 7, 2016		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Par Pharm Inc	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	doxylamine succinate; pyridoxine hydrochloride	TABLET, DELAYED RELEASE;ORAL	208518-001	Dec 6, 2017	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Duchesnay	BONJESTA	doxylamine succinate; pyridoxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209661-001	Nov 7, 2016		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Duchesnay	BONJESTA	doxylamine succinate; pyridoxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209661-001	Nov 7, 2016		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
>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	BONJESTA	doxylamine succinate; pyridoxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209661-001	Nov 7, 2016	⤷ Try a Trial	⤷ Try a Trial
Duchesnay	DICLEGIS	doxylamine succinate; pyridoxine hydrochloride	TABLET, DELAYED RELEASE;ORAL	021876-001	Apr 8, 2013	⤷ Try a Trial	⤷ Try a Trial
Duchesnay	DICLEGIS	doxylamine succinate; pyridoxine hydrochloride	TABLET, DELAYED RELEASE;ORAL	021876-001	Apr 8, 2013	⤷ Try a Trial	⤷ Try a Trial
>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
Hong Kong	1197035	多西拉敏和吡哆醇和/或其代謝物或鹽的製劑 (FORMULATION OF DOXYLAMINE AND PYRIDOXINE AND OR METABOLITES OR SALTS THEREOF)	⤷ Try a Trial
Denmark	3326611		⤷ Try a Trial
New Zealand	729042	Plurimodal release formulation of doxylamine and pyridoxine and/or metabolites or salts thereof	⤷ Try a Trial
South Korea	20140139496	FORMULATION OF DOXYLAMINE AND PYRIDOXINE AND/OR METABOLITES OR SALTS THEREOF	⤷ Try a Trial
Singapore	11201403931Y	FORMULATION OF DOXYLAMINE AND PYRIDOXINE AND/OR METABOLITES OR SALTS THEREOF	⤷ Try a Trial
Eurasian Patent Organization	032671	ТВЕРДАЯ ЛЕКАРСТВЕННАЯ ФОРМА ДЛЯ ПЕРОРАЛЬНОГО ПРИМЕНЕНИЯ, СОДЕРЖАЩАЯ ДОКСИЛАМИН И ПИРИДОКСИН И/ИЛИ ИХ СОЛИ (SOLID ORAL DOSAGE FORM COMPRISING DOXYLAMINE AND PYRIDOXINE AND/OR SALTS THEREOF)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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