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Last Updated: June 13, 2021

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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, Yichang Humanwell, Takeda Pharms Usa, Amneal Pharm, Epic Pharma Llc, Unichem, Watson Labs, and Promius Pharma, and is included in seventeen 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. Twenty-one suppliers are listed for this compound.

Summary 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
Takeda Pharms Usa INTUNIV guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022037-002 Sep 2, 2009 AB RX Yes No   Get Started Free   Get Started Free Y   Get Started Free
Apotex GUANFACINE HYDROCHLORIDE guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 205430-002 Jul 25, 2018 AB RX No No   Get Started Free   Get Started Free   Get Started Free
Sandoz Inc GUANFACINE HYDROCHLORIDE guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 202568-001 Jun 3, 2015 AB RX No No   Get Started Free   Get Started Free   Get Started Free
Unichem GUANFACINE HYDROCHLORIDE guanfacine hydrochloride TABLET;ORAL 214689-001 Mar 3, 2021 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

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 022037-004 Sep 2, 2009   Get Started Free   Get Started Free
Takeda Pharms Usa INTUNIV guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022037-001 Sep 2, 2009   Get Started Free   Get Started Free
Takeda Pharms Usa INTUNIV guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022037-002 Sep 2, 2009   Get Started Free   Get Started Free
Takeda Pharms Usa INTUNIV guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022037-003 Sep 2, 2009   Get Started Free   Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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