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Last Updated: January 20, 2020

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DICLEGIS Drug Profile

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Which patents cover Diclegis, and when can generic versions of Diclegis launch?

Diclegis is a drug marketed by Duchesnay and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-two patent family members in thirty-seven countries.

The generic ingredient in DICLEGIS is doxylamine succinate; pyridoxine hydrochloride. There are fourteen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the doxylamine succinate; pyridoxine hydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Diclegis

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Diclegis was eligible for patent challenges on December 31st, 1968.

Annual sales in 2017 were $269mm indicating the motivation for generic entry.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Drug patent expirations by year for DICLEGIS
Drug Prices for DICLEGIS

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Drug Sales Revenue Trends for DICLEGIS

See drug sales revenues for DICLEGIS

Recent Clinical Trials for DICLEGIS

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

GrĂ¼nenthal, S.A.Phase 1
GrĂ¼nenthal GmbHPhase 1
Premier Research Group plcPhase 4

See all DICLEGIS clinical trials

Recent Litigation for DICLEGIS

Identify potential future generic entrants

District Court Litigation
Case NameDate
Duchesnay Inc. v. Mylan Pharmaceuticals Inc.2015-05-13
Duchesnay Inc. v. Actavis Inc.

See all DICLEGIS litigation

Pharmacology for DICLEGIS
Synonyms for DICLEGIS
4,5-bis(hydroxymethyl)-2-methylpyridin-3-ol; butanedioic acid; N,N-dimethyl-2-(1-phenyl-1-pyridin-2-ylethoxy)ethanamine; hydrochloride
Butanedioic acid, compd. with N,N-dimethyl-2-(1-phenyl-1-(2-pyridinyl)ethoxy)ethanamine (1:1), mixt. with 5-hydroxy-6-methyl-3,4-pyridinedimethanol hydrochloride
Butanedioic acid, compd. with N,N-dimethyl-2-(1-phenyl-1-(2-pyridinyl)ethoxy)ethanamine (1:1),mixt. with 5-hydroxy-6-methyl-3,4-pyridinedimethanol hydrochloride
Doxylamine / pyridoxine
Doxylamine mixture with pyridoxine
Doxylamine succinate / pyridoxine hydrochloride
Doxylamine succinate mixture with pyridoxine hydrochloride
Paragraph IV (Patent) Challenges for DICLEGIS
Tradename Dosage Ingredient NDA Submissiondate
DICLEGIS TABLET, DELAYED RELEASE;ORAL doxylamine succinate; pyridoxine hydrochloride 021876 2013-08-01

US Patents and Regulatory Information for DICLEGIS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
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
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
>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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