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Last Updated: June 14, 2021

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GUANFACINE HYDROCHLORIDE Drug Profile


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When do Guanfacine Hydrochloride patents expire, and what generic alternatives are available?

Guanfacine Hydrochloride is a drug marketed by Actavis Elizabeth, Apotex, Impax Labs Inc, Mylan, Sandoz Inc, Sun Pharm, Teva Pharms Usa, Twi Pharms, Yichang Humanwell, Amneal Pharm, Epic Pharma Llc, Unichem, and Watson Labs. and is included in fifteen NDAs.

The generic ingredient in GUANFACINE HYDROCHLORIDE is guanfacine hydrochloride. There are seven drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the guanfacine hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Guanfacine Hydrochloride

A generic version of GUANFACINE HYDROCHLORIDE was approved as guanfacine hydrochloride by WATSON LABS on October 17th, 1995.

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Drug patent expirations by year for GUANFACINE HYDROCHLORIDE
Recent Clinical Trials for GUANFACINE HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Massachusetts General HospitalPhase 2
University of Alabama at BirminghamN/A
Stanford UniversityPhase 4

See all GUANFACINE HYDROCHLORIDE clinical trials

Pharmacology for GUANFACINE HYDROCHLORIDE
Medical Subject Heading (MeSH) Categories for GUANFACINE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for GUANFACINE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
INTUNIV TABLET, EXTENDED RELEASE;ORAL guanfacine hydrochloride 022037 2009-12-29

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
Mylan GUANFACINE HYDROCHLORIDE guanfacine hydrochloride TABLET;ORAL 074796-001 Jan 27, 1997 DISCN No No   Get Started Free   Get Started Free   Get Started Free
Twi Pharms GUANFACINE HYDROCHLORIDE guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 201408-004 Jun 2, 2015 AB RX No No   Get Started Free   Get Started Free   Get Started Free
Watson Labs GUANFACINE HYDROCHLORIDE guanfacine hydrochloride TABLET;ORAL 074145-001 Oct 17, 1995 AB RX No No   Get Started Free   Get Started Free   Get Started Free
Teva Pharms Usa GUANFACINE HYDROCHLORIDE guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 201382-004 Jun 2, 2015 AB RX No No   Get Started Free   Get Started Free   Get Started Free
Yichang Humanwell GUANFACINE HYDROCHLORIDE guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 213428-001 Nov 25, 2020 AB RX No No   Get Started Free   Get Started Free   Get Started Free
Twi Pharms GUANFACINE HYDROCHLORIDE guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 201408-001 Jun 2, 2015 AB RX No No   Get Started Free   Get Started Free   Get Started Free
Actavis Elizabeth GUANFACINE HYDROCHLORIDE guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 200881-001 Oct 5, 2012 AB RX No No   Get Started Free   Get Started Free   Get Started Free
>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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