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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, Takeda Pharms Usa, Amneal Pharm, Epic Pharma Llc, Watson Labs, and Promius Pharma, and is included in fifteen 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. Nineteen suppliers are listed for this compound.

Summary for guanfacine hydrochloride

International Patents:	10
US Patents:	2
Tradenames:	3
Applicants:	13
NDAs:	15
Drug Master File Entries:	7
Suppliers / Packagers:	19
Bulk Api Vendors:	84
Clinical Trials:	63
Patent Applications:	942
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for guanfacine hydrochloride
DailyMed Link:	guanfacine hydrochloride at DailyMed

Recent Clinical Trials for guanfacine hydrochloride

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

Sponsor	Phase
Stanford University	Phase 4
Winthrop University Hospital	Phase 4
NYU Langone Health	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

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
Mylan	GUANFACINE HYDROCHLORIDE	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	202578-004	Jun 2, 2015		DISCN	No	No
Impax Labs Inc	GUANFACINE HYDROCHLORIDE	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	202238-004	Oct 20, 2015		DISCN	No	No
Impax Labs Inc	GUANFACINE HYDROCHLORIDE	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	202238-001	Oct 20, 2015		DISCN	No	No
Watson Labs	GUANFACINE HYDROCHLORIDE	guanfacine hydrochloride	TABLET;ORAL	074762-002	Jun 25, 1997		DISCN	No	No
Takeda Pharms Usa	INTUNIV	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022037-001	Sep 2, 2009	AB	RX	Yes	No					Y
Mylan	GUANFACINE HYDROCHLORIDE	guanfacine hydrochloride	TABLET;ORAL	074796-001	Jan 27, 1997	AB	RX	No	No
Impax Labs Inc	GUANFACINE HYDROCHLORIDE	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	202238-003	Oct 20, 2015		DISCN	No	No

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	019032-003	Nov 7, 1988
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	022037-003	Sep 2, 2009
Takeda Pharms Usa	INTUNIV	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022037-002	Sep 2, 2009
Promius Pharma	TENEX	guanfacine hydrochloride	TABLET;ORAL	019032-002	Nov 7, 1988
Promius Pharma	TENEX	guanfacine hydrochloride	TABLET;ORAL	019032-001	Oct 27, 1986
Takeda Pharms Usa	INTUNIV	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022037-004	Sep 2, 2009

International Patents for guanfacine hydrochloride

Country	Patent Number	Estimated Expiration
Portugal	1351668
Spain	2527854
Japan	4340840
Denmark	1351668
Canada	2432178
Cyprus	1116023
European Patent Office	1351668