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Serving leading biopharmaceutical companies globally:

Harvard Business School
Johnson and Johnson

Last Updated: February 25, 2021

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DICLEGIS Drug Profile

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When do Diclegis patents expire, and when can generic versions of Diclegis launch?

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

This drug has fifty patent family members in thirty-six countries.

The generic ingredient in DICLEGIS is doxylamine succinate; pyridoxine hydrochloride. There are fourteen drug master file entries for this compound. Six 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

There has been one patent litigation case 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.

Indicators of Generic Entry

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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

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

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

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Pharmacology for DICLEGIS
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
>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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Serving leading biopharmaceutical companies globally:

Express Scripts
Johnson and Johnson
Boehringer Ingelheim

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.