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.

Summary for DOXYLAMINE SUCCINATE

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

Recent Clinical Trials for DOXYLAMINE SUCCINATE

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

Sponsor	Phase
Jixi Maternal and Child Health Hospital	Phase 3
Heilongjiang provincial hospital	Phase 3
Suihua Maternal and Child Health 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

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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	DICLEGIS	doxylamine succinate; pyridoxine hydrochloride	TABLET, DELAYED RELEASE;ORAL	021876-001	Apr 8, 2013	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ 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
Lnk	DOXYLAMINE SUCCINATE	doxylamine succinate	TABLET;ORAL	040564-001	Aug 27, 2004		OTC	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

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