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Serving leading biopharmaceutical companies globally:

Covington
Federal Trade Commission
UBS
Johnson and Johnson
Teva
Queensland Health
Farmers Insurance
Cipla
Cantor Fitzgerald
Cerilliant

Generated: February 23, 2018

DrugPatentWatch Database Preview

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 Actavis Elizabeth, Impax Labs Inc, Mylan Pharms Inc, Sandoz Inc, Sun Pharm Inds Ltd, Teva Pharms Usa, Twi Pharms Inc, Shire, Amneal Pharm, Epic Pharma Llc, Mylan, Watson Labs, and Promius Pharma, and is included in fourteen 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 guanfacine hydrochloride
Pharmacology for guanfacine hydrochloride
Medical Subject Heading (MeSH) Categories for guanfacine hydrochloride

US Patents and Regulatory Information for 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;ORAL 022037-001 Sep 2, 2009 AB RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Impax Labs Inc GUANFACINE HYDROCHLORIDE guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 202238-001 Oct 20, 2015 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Amneal Pharm GUANFACINE HYDROCHLORIDE guanfacine hydrochloride TABLET;ORAL 075109-001 Nov 25, 1998 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Shire INTUNIV guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022037-001 Sep 2, 2009 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Shire INTUNIV guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022037-004 Sep 2, 2009 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Promius Pharma TENEX guanfacine hydrochloride TABLET;ORAL 019032-001 Oct 27, 1986 AB RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Shire INTUNIV guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022037-003 Sep 2, 2009 AB RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Epic Pharma Llc GUANFACINE HYDROCHLORIDE guanfacine hydrochloride TABLET;ORAL 074673-002 Feb 28, 1997 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Epic Pharma Llc GUANFACINE HYDROCHLORIDE guanfacine hydrochloride TABLET;ORAL 074673-001 Feb 28, 1997 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Watson Labs GUANFACINE HYDROCHLORIDE guanfacine hydrochloride TABLET;ORAL 074145-001 Oct 17, 1995 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for guanfacine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Promius Pharma TENEX guanfacine hydrochloride TABLET;ORAL 019032-002 Nov 7, 1988 ➤ Sign Up ➤ Sign Up
Shire INTUNIV guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022037-001 Sep 2, 2009 ➤ Sign Up ➤ Sign Up
Shire INTUNIV guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022037-003 Sep 2, 2009 ➤ Sign Up ➤ Sign Up
Promius Pharma TENEX guanfacine hydrochloride TABLET;ORAL 019032-003 Nov 7, 1988 ➤ Sign Up ➤ Sign Up
Shire INTUNIV guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022037-004 Sep 2, 2009 ➤ Sign Up ➤ Sign Up
Shire INTUNIV guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022037-002 Sep 2, 2009 ➤ Sign Up ➤ Sign Up
Promius Pharma TENEX guanfacine hydrochloride TABLET;ORAL 019032-001 Oct 27, 1986 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Covington
AstraZeneca
QuintilesIMS
Daiichi Sankyo
Dow
Julphar
Teva
Cantor Fitzgerald
Harvard Business School

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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