Guanfacine hydrochloride - Generic Drug Details

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.

Summary for guanfacine hydrochloride

US Patents:	1
Tradenames:	3
Applicants:	16
NDAs:	18
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	22
Raw Ingredient (Bulk) Api Vendors:	101
Clinical Trials:	67
Patent Applications:	7,020
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
New York State Psychiatric Institute	Phase 2
Elkana Kohn	Phase 2
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

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
Mylan	GUANFACINE HYDROCHLORIDE	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	202578-004	Jun 2, 2015		DISCN	No	No
Mylan	GUANFACINE HYDROCHLORIDE	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	202578-002	Jun 2, 2015		DISCN	No	No
Sandoz Inc	GUANFACINE HYDROCHLORIDE	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	202568-002	Jun 3, 2015	AB	RX	No	No
Twi Pharms	GUANFACINE HYDROCHLORIDE	guanfacine hydrochloride	TABLET;ORAL	216399-001	Jun 8, 2022	AB	RX	No	No
Twi Pharms	GUANFACINE HYDROCHLORIDE	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	201408-003	Jun 2, 2015	AB	RX	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	019032-002	Nov 7, 1988
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	022037-004	Sep 2, 2009
Takeda Pharms Usa	INTUNIV	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022037-001	Sep 2, 2009
Promius Pharma	TENEX	guanfacine hydrochloride	TABLET;ORAL	019032-001	Oct 27, 1986
Promius Pharma	TENEX	guanfacine hydrochloride	TABLET;ORAL	019032-003	Nov 7, 1988