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Last Updated: February 23, 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. 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. 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
Teva Pharms Usa GUANFACINE HYDROCHLORIDE guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 201382-003 Jun 2, 2015 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Unichem GUANFACINE HYDROCHLORIDE guanfacine hydrochloride TABLET;ORAL 214689-002 Mar 3, 2021 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Alembic GUANFACINE HYDROCHLORIDE guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 217269-001 Aug 7, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ajanta Pharma Ltd GUANFACINE HYDROCHLORIDE guanfacine hydrochloride TABLET;ORAL 217293-001 Apr 27, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Teva Pharms Usa GUANFACINE HYDROCHLORIDE guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 201382-001 Jun 2, 2015 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Takeda Pharms Usa INTUNIV guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022037-003 Sep 2, 2009 AB RX Yes 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
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 022037-001 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
Takeda Pharms Usa INTUNIV guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022037-003 Sep 2, 2009 ⤷  Try a Trial ⤷  Try a Trial
Promius Pharma TENEX guanfacine hydrochloride TABLET;ORAL 019032-001 Oct 27, 1986 ⤷  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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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