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Last Updated: August 8, 2020

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INTUNIV Drug Profile

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

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

This drug has ten patent family members in nine countries.

The generic ingredient in INTUNIV is guanfacine hydrochloride. There are seven drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the guanfacine hydrochloride profile page.

Drug patent expirations by year for INTUNIV
Drug Prices for INTUNIV

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Drug Sales Revenue Trends for INTUNIV

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Recent Clinical Trials for INTUNIV

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SponsorPhase
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Phase 2
Daniel ConnorPhase 4
McGill University Health CenterN/A

See all INTUNIV clinical trials

Pharmacology for INTUNIV
Paragraph IV (Patent) Challenges for INTUNIV
Tradename Dosage Ingredient NDA Submissiondate
INTUNIV TABLET, EXTENDED RELEASE;ORAL guanfacine hydrochloride 022037 2009-12-29

US Patents and Regulatory Information for INTUNIV

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Shire INTUNIV guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022037-001 Sep 2, 2009 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Shire INTUNIV guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022037-004 Sep 2, 2009 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Shire INTUNIV guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022037-002 Sep 2, 2009 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Shire INTUNIV guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022037-004 Sep 2, 2009 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

Expired US Patents for INTUNIV

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Shire INTUNIV guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022037-001 Sep 2, 2009   Start Trial   Start Trial
Shire INTUNIV guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022037-002 Sep 2, 2009   Start Trial   Start Trial
Shire INTUNIV guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022037-003 Sep 2, 2009   Start Trial   Start Trial
Shire INTUNIV guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022037-004 Sep 2, 2009   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

AstraZeneca
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Colorcon

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