Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: October 16, 2019

DrugPatentWatch Database Preview

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.

Drug patent expirations by year for DICLEGIS
Drug Prices for DICLEGIS

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Drug Sales Revenue Trends for DICLEGIS

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Recent Clinical Trials for DICLEGIS

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SponsorPhase
GrĂ¼nenthal GmbHPhase 1
GrĂ¼nenthal, S.A.Phase 1
Duchesnay Inc.Phase 4

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Recent Litigation for DICLEGIS

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

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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
99007-20-2
AC1L4TES
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
Diclectin
Doxylamine / pyridoxine
Doxylamine mixture with pyridoxine
Doxylamine succinate / pyridoxine hydrochloride
Doxylamine succinate mixture with pyridoxine hydrochloride
LS-45739

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   See Pricing   See Pricing Y   See Pricing
Duchesnay DICLEGIS doxylamine succinate; pyridoxine hydrochloride TABLET, DELAYED RELEASE;ORAL 021876-001 Apr 8, 2013 AB RX Yes Yes   See Pricing   See Pricing Y   See Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration
Paragraph IV (Patent) Challenges for DICLEGIS
Drugname Dosage Strength RLD Date
➤ Subscribe Delayed-release Tablets 10 mg/10 mg ➤ Subscribe   See Pricing

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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 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.