DOXYLAMINE SUCCINATE Drug Patent Profile

Which patents cover Doxylamine Succinate, and when can generic versions of Doxylamine Succinate launch?

Doxylamine Succinate is a drug marketed by Copley Pharm, LNK, Perrigo, Quantum Pharmics, Actavis Labs Fl Inc, Bionpharma, Endo Operations, and Mylan Pharms Inc. and is included in nine NDAs.

The generic ingredient in DOXYLAMINE SUCCINATE 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 Doxylamine Succinate

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

Summary for DOXYLAMINE SUCCINATE

US Patents:	0
Applicants:	8
NDAs:	9
Finished Product Suppliers / Packagers:	31
Raw Ingredient (Bulk) Api Vendors:	95
Clinical Trials:	6
Patent Applications:	1,394
DailyMed Link:	DOXYLAMINE SUCCINATE at DailyMed

Recent Clinical Trials for DOXYLAMINE SUCCINATE

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

Sponsor	Phase
Luoyang Hospital of TCM	Phase 3
Jiamusi Maternal and Child Health Hospital	Phase 3
Xuzhou Central Hospital	Phase 3

See all DOXYLAMINE SUCCINATE clinical trials

Pharmacology for DOXYLAMINE SUCCINATE

Drug Class	Antihistamine
Mechanism of Action	Histamine Receptor Antagonists

Medical Subject Heading (MeSH) Categories for DOXYLAMINE SUCCINATE

Antiemetics

Histamine H1 Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for DOXYLAMINE SUCCINATE

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

US Patents and Regulatory Information for DOXYLAMINE SUCCINATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Copley Pharm	DOXYLAMINE SUCCINATE	doxylamine succinate	TABLET;ORAL	088900-002	Feb 12, 1988		DISCN	No	No
Endo Operations	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	doxylamine succinate; pyridoxine hydrochloride	TABLET, DELAYED RELEASE;ORAL	208518-001	Dec 6, 2017	AB	RX	No	No
Quantum Pharmics	DOXYLAMINE SUCCINATE	doxylamine succinate	TABLET;ORAL	088603-001	Aug 7, 1984		DISCN	No	No
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
Lnk	DOXYLAMINE SUCCINATE	doxylamine succinate	TABLET;ORAL	040564-001	Aug 27, 2004		OTC	No	No
Perrigo	DOXYLAMINE SUCCINATE	doxylamine succinate	TABLET;ORAL	040167-001	Sep 18, 1996		OTC	No	No