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Last Updated: October 17, 2021

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DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE - Generic Drug Details

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

Doxylamine succinate; pyridoxine hydrochloride is the generic ingredient in four branded drugs marketed by Duchesnay, Actavis Labs Fl Inc, Mylan Pharms Inc, Par Pharm Inc, and Sanofi Aventis Us, and is included in six NDAs. There are five patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Doxylamine succinate; pyridoxine hydrochloride has one hundred and nine patent family members in forty-six countries.

There are fourteen drug master file entries for doxylamine succinate; pyridoxine hydrochloride. Six suppliers are listed for this compound.

Recent Clinical Trials for DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE

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

SponsorPhase
GrĂ¼nenthal, S.A.Phase 1
GrĂ¼nenthal GmbHPhase 1
Premier Research Group plcPhase 3

See all DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE clinical trials

Pharmacology for DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
BONJESTA TABLET, EXTENDED RELEASE;ORAL doxylamine succinate; pyridoxine hydrochloride 209661 2018-08-28
DICLEGIS TABLET, DELAYED RELEASE;ORAL doxylamine succinate; pyridoxine hydrochloride 021876 2013-08-01

US Patents and Regulatory Information for DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
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 it Free ⤷  Try it Free ⤷  Try it Free
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 it Free ⤷  Try it Free ⤷  Try it Free
Duchesnay BONJESTA doxylamine succinate; pyridoxine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209661-001 Nov 7, 2016 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Duchesnay DICLEGIS doxylamine succinate; pyridoxine hydrochloride TABLET, DELAYED RELEASE;ORAL 021876-001 Apr 8, 2013 ⤷  Try it Free ⤷  Try it Free
Duchesnay BONJESTA doxylamine succinate; pyridoxine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209661-001 Nov 7, 2016 ⤷  Try it Free ⤷  Try it Free
Duchesnay DICLEGIS doxylamine succinate; pyridoxine hydrochloride TABLET, DELAYED RELEASE;ORAL 021876-001 Apr 8, 2013 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
McKinsey
Medtronic
Baxter
Colorcon
Johnson and Johnson

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