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Generated: March 24, 2019

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Doxylamine succinate; pyridoxine hydrochloride - Generic Drug Details

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What are the generic sources for doxylamine succinate; pyridoxine hydrochloride and what is the scope of doxylamine succinate; pyridoxine hydrochloride 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 ninety-six patent family members in forty-two countries.

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

Pharmacology for doxylamine succinate; pyridoxine hydrochloride

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

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