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Last Updated: December 1, 2022

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, Aurobindo Pharma Usa, Epic Pharma Llc, Unichem, Watson Labs, and Promius Pharma, and is included in eighteen NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

Recent Clinical Trials for guanfacine hydrochloride

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

SponsorPhase
New York State Psychiatric InstitutePhase 2
Elkana KohnPhase 2
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 Strength NDA ANDAs Submitted Submissiondate
INTUNIV Extended-release Tablets guanfacine hydrochloride 1 mg, 2 mg, 3 mg and 4 mg 022037 1 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
Yichang Humanwell GUANFACINE HYDROCHLORIDE guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 213428-004 Nov 25, 2020 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan GUANFACINE HYDROCHLORIDE guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 202578-004 Jun 2, 2015 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan GUANFACINE HYDROCHLORIDE guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 202578-002 Jun 2, 2015 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sandoz Inc GUANFACINE HYDROCHLORIDE guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 202568-002 Jun 3, 2015 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Twi Pharms GUANFACINE HYDROCHLORIDE guanfacine hydrochloride TABLET;ORAL 216399-001 Jun 8, 2022 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Twi Pharms GUANFACINE HYDROCHLORIDE guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 201408-003 Jun 2, 2015 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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
Promius Pharma TENEX guanfacine hydrochloride TABLET;ORAL 019032-002 Nov 7, 1988 See Plans and Pricing See Plans and Pricing
Takeda Pharms Usa INTUNIV guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022037-004 Sep 2, 2009 See Plans and Pricing See Plans and Pricing
Takeda Pharms Usa INTUNIV guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022037-004 Sep 2, 2009 See Plans and Pricing See Plans and Pricing
Takeda Pharms Usa INTUNIV guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022037-001 Sep 2, 2009 See Plans and Pricing See Plans and Pricing
Promius Pharma TENEX guanfacine hydrochloride TABLET;ORAL 019032-001 Oct 27, 1986 See Plans and Pricing See Plans and Pricing
Promius Pharma TENEX guanfacine hydrochloride TABLET;ORAL 019032-003 Nov 7, 1988 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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