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Merck
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Chinese Patent Office
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Generated: April 23, 2018

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-three 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
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 N 54092-513-02
INTUNIV guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022037 NDA Shire US Manufacturing Inc. 54092-513 N 54092-513-03

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

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Fish and Richardson
QuintilesIMS
US Army
AstraZeneca
Teva
Harvard Business School
Boehringer Ingelheim
Fuji

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