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Last Updated: March 28, 2024

DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE Drug Patent Profile


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Which patents cover Doxylamine Succinate And Pyridoxine Hydrochloride, and what generic alternatives are available?

Doxylamine Succinate And Pyridoxine Hydrochloride is a drug marketed by Actavis Labs Fl Inc, Bionpharma, Mylan Pharms Inc, and Par Pharm Inc. and is included in five NDAs.

The generic ingredient in DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE 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 And Pyridoxine Hydrochloride

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

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Summary for DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE
US Patents:0
Applicants:4
NDAs:5
Finished Product Suppliers / Packagers: 5
Clinical Trials: 4
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE?DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE excipients list
DailyMed Link:DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE at DailyMed
Drug patent expirations by year for DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE
Recent Clinical Trials for DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE

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

SponsorPhase
Hegang Maternal and Child Health HospitalPhase 3
Shuangyashan Maternal and Child Health HospitalPhase 3
Luoyang Hospital of TCMPhase 3

See all DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE clinical trials

Pharmacology for DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE

US Patents and Regulatory Information for DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE

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, DELAYED RELEASE;ORAL 205811-001 Aug 19, 2016 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bionpharma DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE doxylamine succinate; pyridoxine hydrochloride TABLET, DELAYED RELEASE;ORAL 217000-001 Aug 4, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
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
>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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