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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

International Patents:	10
US Patents:	2
Tradenames:	3
Applicants:	15
NDAs:	17
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	21
Raw Ingredient (Bulk) Api Vendors:	94
Clinical Trials:	65
Patent Applications:	986
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for guanfacine hydrochloride
What excipients (inactive ingredients) are in guanfacine hydrochloride?	guanfacine hydrochloride excipients list
DailyMed Link:	guanfacine hydrochloride at DailyMed

Recent Clinical Trials for guanfacine hydrochloride

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

Sponsor	Phase
Massachusetts General Hospital	Phase 2
University of Alabama at Birmingham	N/A
Stanford University	Phase 4

See all guanfacine hydrochloride clinical trials

Pharmacology for guanfacine hydrochloride

Drug Class	Central alpha-2 Adrenergic Agonist
Mechanism of Action	Adrenergic alpha2-Agonists

Medical Subject Heading (MeSH) Categories for guanfacine hydrochloride

Adrenergic alpha-2 Receptor Agonists

Antihypertensive Agents

ATC Classes for guanfacine hydrochloride

C02AC	Imidazoline receptor agonists
C02A	ANTIADRENERGIC AGENTS, CENTRALLY ACTING
C02	ANTIHYPERTENSIVES
C	Cardiovascular system

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					Y
Apotex	GUANFACINE HYDROCHLORIDE	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205430-002	Jul 25, 2018	AB	RX	No	No
Sandoz Inc	GUANFACINE HYDROCHLORIDE	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	202568-001	Jun 3, 2015	AB	RX	No	No
Unichem	GUANFACINE HYDROCHLORIDE	guanfacine hydrochloride	TABLET;ORAL	214689-001	Mar 3, 2021	AB	RX	No	No

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
Takeda Pharms Usa	INTUNIV	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022037-001	Sep 2, 2009
Takeda Pharms Usa	INTUNIV	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022037-002	Sep 2, 2009
Takeda Pharms Usa	INTUNIV	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022037-003	Sep 2, 2009

International Patents for guanfacine hydrochloride

Country	Patent Number	Estimated Expiration
European Patent Office	1351668
World Intellectual Property Organization (WIPO)	02058676
Japan	2004518676
Portugal	1351668