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, Mylan Pharms Inc, Par Pharm Inc, and Sanofi Aventis Us, and is included in six NDAs. There are five 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 one hundred and six patent family members in forty-six countries.

There are fourteen drug master file entries for doxylamine succinate; pyridoxine hydrochloride. Six suppliers are listed for this compound.

Summary for doxylamine succinate; pyridoxine hydrochloride

International Patents:	106
US Patents:	5
Tradenames:	4
Applicants:	5
NDAs:	6
Drug Master File Entries:	14
Suppliers / Packagers:	6
Clinical Trials:	3
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
Grünenthal, S.A.	Phase 1
Grünenthal GmbH	Phase 1
Premier Research Group plc	Phase 3

See all doxylamine succinate; pyridoxine hydrochloride clinical trials

Pharmacology for doxylamine succinate; pyridoxine hydrochloride

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

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

Tradename	Dosage	Ingredient	NDA	Submissiondate
BONJESTA	TABLET, EXTENDED RELEASE;ORAL	doxylamine succinate; pyridoxine hydrochloride	209661	2018-08-28
DICLEGIS	TABLET, DELAYED RELEASE;ORAL	doxylamine succinate; pyridoxine hydrochloride	021876	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
Duchesnay	BONJESTA	doxylamine succinate; pyridoxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209661-001	Nov 7, 2016		RX	Yes	Yes	Start Trial	Start Trial	Y			Start Trial
Sanofi Aventis Us	BENDECTIN	doxylamine succinate; pyridoxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	010598-002	Approved Prior to Jan 1, 1982		DISCN	No	No	Start Trial	Start Trial				Start Trial
Duchesnay	BONJESTA	doxylamine succinate; pyridoxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209661-001	Nov 7, 2016		RX	Yes	Yes	Start Trial	Start Trial	Y			Start 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	Start Trial	Start Trial				Start Trial
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	Start Trial	Start Trial				Start 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	DICLEGIS	doxylamine succinate; pyridoxine hydrochloride	TABLET, DELAYED RELEASE;ORAL	021876-001	Apr 8, 2013	Start Trial	Start Trial
Duchesnay	BONJESTA	doxylamine succinate; pyridoxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209661-001	Nov 7, 2016	Start Trial	Start 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	Estimated Expiration
South Korea	20140139496	Start Trial
Israel	233644	Start Trial
France	2826277	Start Trial
Iceland	6412	Start Trial
Lithuania	3326611	Start Trial
>Country	>Patent Number	>Estimated Expiration

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