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Last Updated: March 28, 2024

Doxylamine succinate - Generic Drug Details


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What are the generic drug 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, Mylan Pharms Inc, and Par Pharm 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
Recent Clinical Trials for doxylamine succinate

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

SponsorPhase
Heilongjiang provincial hospitalPhase 3
Suihua Maternal and Child Health HospitalPhase 3
Affiliated Hospital of Jiamusi Medical UniversityPhase 3

See all doxylamine succinate clinical trials

Pharmacology for doxylamine succinate
Drug ClassAntihistamine
Mechanism of ActionHistamine Receptor Antagonists
Medical Subject Heading (MeSH) Categories for doxylamine succinate

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
Actavis Labs Fl Inc DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE doxylamine succinate; pyridoxine hydrochloride TABLET, EXTENDED RELEASE;ORAL 212472-001 Mar 1, 2022 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lnk DOXYLAMINE SUCCINATE doxylamine succinate TABLET;ORAL 040564-001 Aug 27, 2004 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us DECAPRYN doxylamine succinate TABLET;ORAL 006412-014 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us DECAPRYN doxylamine succinate TABLET;ORAL 006412-015 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Copley Pharm DOXYLAMINE SUCCINATE doxylamine succinate TABLET;ORAL 088900-002 Feb 12, 1988 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Duchesnay BONJESTA doxylamine succinate; pyridoxine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209661-001 Nov 7, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Quantum Pharmics DOXYLAMINE SUCCINATE doxylamine succinate TABLET;ORAL 088603-001 Aug 7, 1984 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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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