Get our Free Patent Expiration Newsletter

Serving leading biopharmaceutical companies globally:

AstraZeneca
Johnson and Johnson
Moodys
McKinsey
Merck
Colorcon

Last Updated: November 13, 2019

DrugPatentWatch Database Preview

Doxylamine succinate; pyridoxine hydrochloride - Generic Drug Details

See Plans and Pricing

« Back to Dashboard

What are the generic 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, Par Pharm Inc, and Sanofi Aventis Us, and is included in five NDAs. There are six 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 eleven patent family members in forty-two countries.

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

Recent Clinical Trials for doxylamine succinate; pyridoxine hydrochloride

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

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

See all doxylamine succinate; pyridoxine hydrochloride clinical trials

Recent Litigation for doxylamine succinate; pyridoxine hydrochloride

Identify potential future generic entrants

District Court Litigation
Case NameDate
Duchesnay Inc. v. Mylan Pharmaceuticals Inc.2015-05-13
Michael R Mastro2009-07-10
Duchesnay Inc. v. Actavis Inc.

See all doxylamine succinate; pyridoxine hydrochloride litigation

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
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
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
Duchesnay DICLEGIS doxylamine succinate; pyridoxine hydrochloride TABLET, DELAYED RELEASE;ORAL 021876-001 Apr 8, 2013 AB RX Yes Yes   Start Trial   Start Trial Y   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
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
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
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
>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   Start Trial   Start Trial
Duchesnay BONJESTA doxylamine succinate; pyridoxine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209661-001 Nov 7, 2016   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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

Serving leading biopharmaceutical companies globally:

Mallinckrodt
McKinsey
Express Scripts
Boehringer Ingelheim
AstraZeneca
Medtronic

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 verifification 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.