DOXYLAMINE SUCCINATE - Generic Drug Details

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What are the generic sources for doxylamine succinate and what is the scope of patent protection?

Doxylamine succinate is the generic ingredient in eight branded drugs marketed by Pfizer, Sanofi Aventis Us, Par Pharm, Copley Pharm, LNK, Perrigo, Quantum Pharmics, Chattem, Duchesnay, Actavis Labs Fl Inc, Bionpharma, Endo Operations, and Mylan Pharms Inc, and is included in sixteen NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are thirteen drug master file entries for doxylamine succinate. Thirty-one suppliers are listed for this compound.

Sponsor	Phase
Heilongjiang provincial hospital	Phase 3
Suihua Maternal and Child Health Hospital	Phase 3
Affiliated Hospital of Jiamusi Medical University	Phase 3

Sponsor

Phase

Heilongjiang provincial hospital

Phase 3

Suihua Maternal and Child Health Hospital

Phase 3

Affiliated Hospital of Jiamusi Medical University

Phase 3

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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
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	⤷ 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
Chattem	UNISOM	doxylamine succinate	TABLET;ORAL	018066-001	Approved Prior to Jan 1, 1982		OTC	Yes	Yes	⤷ 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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

US Patents:	4
Tradenames:	8
Applicants:	13
NDAs:	16
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	31
Raw Ingredient (Bulk) Api Vendors:	95
Clinical Trials:	6
Patent Applications:	2,231
What excipients (inactive ingredients) are in DOXYLAMINE SUCCINATE?	DOXYLAMINE SUCCINATE excipients list
DailyMed Link:	DOXYLAMINE SUCCINATE at DailyMed

Drug Class	Antihistamine
Mechanism of Action	Histamine Receptor Antagonists