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Serving leading biopharmaceutical companies globally:

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Federal Trade Commission
Colorcon
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Queensland Health
Deloitte
Medtronic
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Generated: October 19, 2017

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Guanfacine hydrochloride - Generic Drug Details

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What are the generic drug sources for guanfacine hydrochloride and what is the scope of guanfacine hydrochloride patent protection?

Guanfacine hydrochloride
is the generic ingredient in three branded drugs marketed by Twi Pharms Inc, Amneal Pharm, Promius Pharma, Shire, Impax Labs Inc, Watson Labs, Sandoz Inc, Epic Pharma Llc, Mylan Pharms Inc, Actavis Elizabeth, Teva Pharms Usa, and Mylan, and is included in thirteen NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for guanfacine hydrochloride. Twenty-five suppliers are listed for this compound.

Summary for Generic Name: guanfacine hydrochloride

US Patents:2
Tradenames:3
Applicants:12
NDAs:13
Drug Master File Entries: see list7
Suppliers / Packagers: see list25
Bulk Api Vendors: see list43
Clinical Trials: see list2,323
Patent Applications: see list794
Therapeutic Class:Cardiovascular Agents
Drug Prices:see low prices
DailyMed Link:guanfacine hydrochloride at DailyMed

Pharmacology for Ingredient: guanfacine hydrochloride

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;ORAL022037-003Sep 2, 2009ABRXYesNo► Subscribe► SubscribeY► Subscribe
Impax Labs Inc
GUANFACINE HYDROCHLORIDE
guanfacine hydrochloride
TABLET, EXTENDED RELEASE;ORAL202238-002Oct 20, 2015DISCNNoNo► Subscribe► Subscribe► Subscribe
Shire
INTUNIV
guanfacine hydrochloride
TABLET, EXTENDED RELEASE;ORAL022037-002Sep 2, 2009ABRXYesNo► Subscribe► Subscribe► Subscribe
Shire
INTUNIV
guanfacine hydrochloride
TABLET, EXTENDED RELEASE;ORAL022037-004Sep 2, 2009ABRXYesYes► Subscribe► SubscribeY► Subscribe
Twi Pharms Inc
GUANFACINE HYDROCHLORIDE
guanfacine hydrochloride
TABLET, EXTENDED RELEASE;ORAL201408-003Jun 2, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Actavis Elizabeth
GUANFACINE HYDROCHLORIDE
guanfacine hydrochloride
TABLET, EXTENDED RELEASE;ORAL200881-001Oct 5, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
Promius Pharma
TENEX
guanfacine hydrochloride
TABLET;ORAL019032-003Nov 7, 1988DISCNNoNo► Subscribe► Subscribe► Subscribe
Sandoz Inc
GUANFACINE HYDROCHLORIDE
guanfacine hydrochloride
TABLET, EXTENDED RELEASE;ORAL202568-002Jun 3, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan
GUANFACINE HYDROCHLORIDE
guanfacine hydrochloride
TABLET;ORAL074796-002Jan 27, 1997ABRXNoNo► Subscribe► Subscribe► Subscribe
Impax Labs Inc
GUANFACINE HYDROCHLORIDE
guanfacine hydrochloride
TABLET, EXTENDED RELEASE;ORAL202238-001Oct 20, 2015DISCNNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: guanfacine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Shire
INTUNIV
guanfacine hydrochloride
TABLET, EXTENDED RELEASE;ORAL022037-004Sep 2, 2009► Subscribe► Subscribe
Promius Pharma
TENEX
guanfacine hydrochloride
TABLET;ORAL019032-001Oct 27, 1986► Subscribe► Subscribe
Shire
INTUNIV
guanfacine hydrochloride
TABLET, EXTENDED RELEASE;ORAL022037-003Sep 2, 2009► Subscribe► Subscribe
Shire
INTUNIV
guanfacine hydrochloride
TABLET, EXTENDED RELEASE;ORAL022037-002Sep 2, 2009► Subscribe► Subscribe
Promius Pharma
TENEX
guanfacine hydrochloride
TABLET;ORAL019032-003Nov 7, 1988► Subscribe► Subscribe
Shire
INTUNIV
guanfacine hydrochloride
TABLET, EXTENDED RELEASE;ORAL022037-001Sep 2, 2009► Subscribe► Subscribe
Promius Pharma
TENEX
guanfacine hydrochloride
TABLET;ORAL019032-002Nov 7, 1988► Subscribe► Subscribe
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Medtronic
US Department of Justice
Dow
Harvard Business School
Express Scripts
Julphar
Cipla
Argus Health
QuintilesIMS
Moodys

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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