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Last Updated: September 22, 2020

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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 patent protection?

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

Guanfacine hydrochloride has ten patent family members in nine countries.

There are seven drug master file entries for guanfacine hydrochloride. Nineteen suppliers are listed for this compound.

Recent Clinical Trials for GUANFACINE HYDROCHLORIDE

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

SponsorPhase
Stanford UniversityPhase 4
Winthrop University HospitalPhase 4
NYU Langone HealthPhase 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
Sun Pharm GUANFACINE HYDROCHLORIDE guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 205689-001 Nov 16, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Sandoz Inc GUANFACINE HYDROCHLORIDE guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 202568-004 Jun 3, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Actavis Elizabeth GUANFACINE HYDROCHLORIDE guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 200881-002 Oct 5, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Twi Pharms GUANFACINE HYDROCHLORIDE guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 201408-002 Jun 2, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Takeda Pharms Usa INTUNIV guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022037-004 Sep 2, 2009 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for GUANFACINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Takeda Pharms Usa INTUNIV guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022037-001 Sep 2, 2009   Start Trial   Start Trial
Promius Pharma TENEX guanfacine hydrochloride TABLET;ORAL 019032-001 Oct 27, 1986   Start Trial   Start Trial
Takeda Pharms Usa INTUNIV guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022037-004 Sep 2, 2009   Start Trial   Start Trial
Takeda Pharms Usa INTUNIV guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022037-002 Sep 2, 2009   Start Trial   Start Trial
Takeda Pharms Usa INTUNIV guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022037-003 Sep 2, 2009   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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