Generated: December 12, 2017
DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 022037
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, 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.
Pharmacology for NDA: 022037
Medical Subject Heading (MeSH) Categories for 022037
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Summary for product number 001
|Active Rx/OTC/Discontinued:||RX||Dosage:||TABLET, EXTENDED RELEASE;ORAL||Strength||EQ 1MG BASE|
|Approval Date:||Sep 2, 2009||TE:||AB||RLD:||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
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