Doxylamine succinate - Generic Drug Details

✉ Email this page to a colleague

What are the generic sources for doxylamine succinate and what is the scope of freedom to operate?

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
Affiliated Hospital of Jiamusi Medical University	Phase 3
Mudanjaing Maternal and Child Health Hospital	Phase 3
Jiangxi 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

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Sign Up
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

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.