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Last Updated: March 19, 2024

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, Alembic, Apotex, Impax Labs Inc, Mylan, Sandoz, Sun Pharm, Teva Pharms Usa, Twi Pharms, Yichang Humanwell, Takeda Pharms Usa, Ajanta Pharma Ltd, Amneal Pharm, Aurobindo Pharma Usa, Epic Pharma Llc, I 3 Pharms, Rubicon, Unichem, Watson Labs, and Promius Pharma, and is included in twenty-two NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for guanfacine hydrochloride. Thirty-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
Watson Labs GUANFACINE HYDROCHLORIDE guanfacine hydrochloride TABLET;ORAL 074762-001 Jun 25, 1997 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Yichang Humanwell GUANFACINE HYDROCHLORIDE guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 213428-004 Nov 25, 2020 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sun Pharm GUANFACINE HYDROCHLORIDE guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 205689-004 Nov 16, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amneal Pharm GUANFACINE HYDROCHLORIDE guanfacine hydrochloride TABLET;ORAL 075109-002 Nov 25, 1998 AB RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Apotex GUANFACINE HYDROCHLORIDE guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 205430-002 Jul 25, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Apotex GUANFACINE HYDROCHLORIDE guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 205430-001 Jul 25, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sandoz GUANFACINE HYDROCHLORIDE guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 202568-001 Jun 3, 2015 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 022037-003 Sep 2, 2009 ⤷  Try a Trial ⤷  Try a Trial
Takeda Pharms Usa INTUNIV guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022037-001 Sep 2, 2009 ⤷  Try a Trial ⤷  Try a Trial
Takeda Pharms Usa INTUNIV guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022037-002 Sep 2, 2009 ⤷  Try a Trial ⤷  Try a Trial
Promius Pharma TENEX guanfacine hydrochloride TABLET;ORAL 019032-003 Nov 7, 1988 ⤷  Try a Trial ⤷  Try a Trial
Promius Pharma TENEX guanfacine hydrochloride TABLET;ORAL 019032-002 Nov 7, 1988 ⤷  Try a Trial ⤷  Try a Trial
Takeda Pharms Usa INTUNIV guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022037-002 Sep 2, 2009 ⤷  Try a Trial ⤷  Try a Trial
Takeda Pharms Usa INTUNIV guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022037-004 Sep 2, 2009 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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