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Last Updated: August 7, 2020

DrugPatentWatch Database Preview

Doxylamine succinate - Generic Drug Details

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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, and Par Pharm Inc, and is included in thirteen NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

Recent Clinical Trials for doxylamine succinate

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

SponsorPhase
Grünenthal GmbHPhase 1
Grünenthal, S.A.Phase 1
Azidus BrasilPhase 3

See all doxylamine succinate clinical trials

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
Duchesnay BONJESTA doxylamine succinate; pyridoxine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209661-001 Nov 7, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Copley Pharm DOXYLAMINE SUCCINATE doxylamine succinate TABLET;ORAL 088900-002 Feb 12, 1988 DISCN No No   Start Trial   Start Trial   Start Trial
Quantum Pharmics DOXYLAMINE SUCCINATE doxylamine succinate TABLET;ORAL 088603-001 Aug 7, 1984 DISCN No No   Start Trial   Start Trial   Start Trial
Perrigo DOXYLAMINE SUCCINATE doxylamine succinate TABLET;ORAL 040167-001 Sep 18, 1996 OTC No No   Start Trial   Start Trial   Start Trial
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   Start Trial   Start Trial   Start Trial
Par Pharm Inc DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE doxylamine succinate; pyridoxine hydrochloride TABLET, DELAYED RELEASE;ORAL 208518-001 Dec 6, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Chattem UNISOM doxylamine succinate TABLET;ORAL 018066-001 Approved Prior to Jan 1, 1982 OTC Yes Yes   Start Trial   Start Trial   Start 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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Serving leading biopharmaceutical companies globally:

Medtronic
Express Scripts
McKinsey
Merck
Baxter
McKesson

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