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Generated: December 12, 2017

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 two suppliers. 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-five suppliers are listed for this compound. Additional details are available on the guanfacine hydrochloride profile page.

Summary for 022037

Tradename:1
Applicant:1
Ingredient:1
Patents:2
Therapeutic Class:Cardiovascular Agents

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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 1MG BASE
Approval Date:Sep 2, 2009TE:ABRLD:Yes
Regulatory Exclusivity Expiration:May 19, 2018
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Regulatory Exclusivity Expiration:Mar 18, 2018
Regulatory Exclusivity Use:UPDATE TO THE LABELING TO REFLECT THE RESULTS OF A LONG-TERM MAINTENANCE TREATMENT STUDY OF ADHD IN CHILDREN AND ADOLESCENTS AGES 6-17.
Regulatory Exclusivity Expiration:Nov 19, 2017
Regulatory Exclusivity Use:UPDATES TO THE DOSAGE AND ADMINISTRATION SECTION OF THE LABELING TO REFLECT THE RESULTS OF TWO SHORT TERM STUDIES EVALUATING THE SAFETY AND EFFICACY OF INTUNIV IN CHILDREN AND ADOLESCENTS AGES 6 TO 17 WITH ADHD.

Expired Orange Book Patents for NDA: 022037

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
ShireINTUNIVguanfacine hydrochlorideTABLET, EXTENDED RELEASE;ORAL022037-001Sep 2, 2009► Subscribe► Subscribe
ShireINTUNIVguanfacine hydrochlorideTABLET, EXTENDED RELEASE;ORAL022037-002Sep 2, 2009► Subscribe► Subscribe
ShireINTUNIVguanfacine hydrochlorideTABLET, EXTENDED RELEASE;ORAL022037-003Sep 2, 2009► Subscribe► Subscribe
ShireINTUNIVguanfacine hydrochlorideTABLET, EXTENDED RELEASE;ORAL022037-004Sep 2, 2009► Subscribe► Subscribe
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Cipla
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