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DICLEGIS Drug Profile

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Which patents cover Diclegis, and what substitute generic drugs are available?

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 patent family members in thirty-six countries.

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

Summary for Tradename: DICLEGIS

Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Clinical Trials: see list1
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:DICLEGIS at DailyMed

Pharmacology for Tradename: DICLEGIS

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Duchesnay
DICLEGIS
doxylamine succinate; pyridoxine hydrochloride
TABLET, DELAYED RELEASE;ORAL021876-001Apr 8, 2013RXYesYes6,340,695► SubscribeY ► Subscribe
Duchesnay
DICLEGIS
doxylamine succinate; pyridoxine hydrochloride
TABLET, DELAYED RELEASE;ORAL021876-001Apr 8, 2013RXYesYes7,560,122► SubscribeY ► Subscribe
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Paragraph IV activity for: DICLEGIS

Drugname Dosage Strength RLD Submissiondate
doxylamine succinate and pyridoxine hydrochlorideDelayed-release Tablets10 mg/10 mgDiclegis8/1/2013

International Patent Family for Tradename: DICLEGIS

Country Document Number Estimated Expiration
Japan4242763► Subscribe
France2841783► Subscribe
Turkey200201685► Subscribe
Ireland20030484► Subscribe
Greece1004641► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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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.

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