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Last Updated: December 5, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022037

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NDA 022037 describes INTUNIV, which is a drug marketed by Shire and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the INTUNIV profile page.

The generic ingredient in INTUNIV is guanfacine hydrochloride. There are seven drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the guanfacine hydrochloride profile page.
Summary for 022037
Tradename:INTUNIV
Applicant:Shire
Ingredient:guanfacine hydrochloride
Patents:2
Pharmacology for NDA: 022037
Mechanism of ActionAdrenergic alpha2-Agonists
Medical Subject Heading (MeSH) Categories for 022037
Suppliers and Packaging for NDA: 022037
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INTUNIV guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022037 NDA Shire US Manufacturing Inc. 54092-513 54092-513-02 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (54092-513-02)
INTUNIV guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022037 NDA Shire US Manufacturing Inc. 54092-513 54092-513-03 7 TABLET, EXTENDED RELEASE in 1 BOTTLE (54092-513-03)
Paragraph IV (Patent) Challenges for 022037
Tradename Dosage Ingredient NDA Submissiondate
INTUNIV TABLET, EXTENDED RELEASE;ORAL guanfacine hydrochloride 022037 2009-12-29

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 1MG BASE
Approval Date:Sep 2, 2009TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Jun 20, 2021Product Flag?Substance Flag?Delist Request?Y
Patent:  Start TrialPatent Expiration:Jan 4, 2023Product Flag?Substance Flag?Delist Request?Y

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 2MG BASE
Approval Date:Sep 2, 2009TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Jun 20, 2021Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 022037

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 022037-003 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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