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McKinsey
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Last Updated: May 26, 2022

DICLEGIS Drug Patent 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.

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.

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

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

See all DICLEGIS clinical trials

Paragraph IV (Patent) Challenges for DICLEGIS
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
DICLEGIS Delayed-release Tablets doxylamine succinate; pyridoxine hydrochloride 10 mg/10 mg 021876 1 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 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 DICLEGIS

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 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 DICLEGIS

See the table below for patents covering DICLEGIS around the world.

Country Patent Number Title Estimated Expiration
Belgium 1014929 FORMULATION A DELAI D'ACTION RAPIDE. See Plans and Pricing
Finland 20021708 See Plans and Pricing
Monaco 200066 Forme posologique pharmaceutique portant une signalétique indiquant une parfaite innocuité en cas degrossesse See Plans and Pricing
Norway 332190 See Plans and Pricing
European Patent Office 1397133 FORME GALENIQUE A COURT DELAI D'ACTION (RAPID ONSET FORMULATION) See Plans and Pricing
Taiwan 200400835 Pharmaceutical dosage form bearing pregnancy-friendly indicia See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Merck
Dow
McKinsey
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.