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Last Updated: October 6, 2022

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 seven NDAs. There are four 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 sixty patent family members in thirty countries.

Six suppliers are listed for this compound.

Recent Clinical Trials for doxylamine succinate; pyridoxine hydrochloride

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

SponsorPhase
Affiliated Hospital of Jiamusi Medical UniversityPhase 3
Mudanjaing Maternal and Child Health HospitalPhase 3
Jiangxi Maternal and Child Health HospitalPhase 3

See all doxylamine succinate; pyridoxine hydrochloride clinical trials

Pharmacology for doxylamine succinate; pyridoxine hydrochloride
Anatomical Therapeutic Chemical (ATC) Classes for doxylamine succinate; pyridoxine hydrochloride
Paragraph IV (Patent) Challenges for DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
BONJESTA Extended-release Tablets doxylamine succinate; pyridoxine hydrochloride 20 mg/20 mg 209661 1 2018-08-28
DICLEGIS Delayed-release Tablets doxylamine succinate; pyridoxine hydrochloride 10 mg/10 mg 021876 1 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 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Sanofi Aventis Us BENDECTIN doxylamine succinate; pyridoxine hydrochloride TABLET, EXTENDED RELEASE;ORAL 010598-002 Approved Prior to Jan 1, 1982 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Duchesnay BONJESTA doxylamine succinate; pyridoxine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209661-001 Nov 7, 2016 See Plans and Pricing See Plans and Pricing
Duchesnay DICLEGIS doxylamine succinate; pyridoxine hydrochloride TABLET, DELAYED RELEASE;ORAL 021876-001 Apr 8, 2013 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for doxylamine succinate; pyridoxine hydrochloride

Country Patent Number Title Estimated Expiration
Israel 233644 צורות מינון בעלות שחרור דואלי הניתנות דרך הפה אשר מכילות דוקסילאמין ופירידוקסין, ערכות המכילות אותן ושימושן להקלת סימפטומים של בחילה והקאה (Dual release oral dosage forms comprising doxylamine and pyridoxine, kits comprising them and their use in alleviating the symptoms of nausea and vomiting) See Plans and Pricing
Japan 2015508082 ドキシラミンおよびピリドキシン、ならびに/またはその代謝物もしくは塩の製剤 See Plans and Pricing
Japan 2016053092 ドキシラミンおよびピリドキシン、ならびに/またはその代謝物もしくは塩の製剤 (FORMULATION OF DOXYLAMINE AND PYRIDOXINE AND/OR METABOLITES OR SALTS THEREOF) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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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 verification 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.