GUANFACINE HYDROCHLORIDE Drug Patent Profile

When do Guanfacine Hydrochloride patents expire, and what generic alternatives are available?

Guanfacine Hydrochloride is a drug marketed by Actavis Elizabeth, Alembic, Apotex, Impax Labs Inc, Mylan, Sandoz, Sun Pharm, Teva Pharms Usa, Twi Pharms, Yichang Humanwell, Ajanta Pharma Ltd, Amneal Pharm, Aurobindo Pharma Usa, Epic Pharma Llc, I 3 Pharms, Rubicon, Unichem, Watson Labs, and Xiromed. and is included in twenty-one NDAs.

The generic ingredient in GUANFACINE HYDROCHLORIDE is guanfacine hydrochloride. There are seven drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the guanfacine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Guanfacine Hydrochloride

A generic version of GUANFACINE HYDROCHLORIDE was approved as guanfacine hydrochloride by WATSON LABS on October 17^th, 1995.

Summary for GUANFACINE HYDROCHLORIDE

US Patents:	0
Applicants:	19
NDAs:	21
Finished Product Suppliers / Packagers:	31
Raw Ingredient (Bulk) Api Vendors:	110
Clinical Trials:	68
Patent Applications:	3,182
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
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

Anatomical Therapeutic Chemical (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	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
Ajanta Pharma Ltd	GUANFACINE HYDROCHLORIDE	guanfacine hydrochloride	TABLET;ORAL	217293-001	Apr 27, 2023	AB	RX	No	No
Teva Pharms Usa	GUANFACINE HYDROCHLORIDE	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	201382-004	Jun 2, 2015	AB	RX	No	No
I 3 Pharms	GUANFACINE HYDROCHLORIDE	guanfacine hydrochloride	TABLET;ORAL	216828-001	Oct 5, 2023	AB	RX	No	No
Watson Labs	GUANFACINE HYDROCHLORIDE	guanfacine hydrochloride	TABLET;ORAL	074762-002	Jun 25, 1997		DISCN	No	No
Aurobindo Pharma Usa	GUANFACINE HYDROCHLORIDE	guanfacine hydrochloride	TABLET;ORAL	074796-001	Jan 27, 1997	AB	RX	No	No
I 3 Pharms	GUANFACINE HYDROCHLORIDE	guanfacine hydrochloride	TABLET;ORAL	216828-002	Oct 5, 2023	AB	RX	No	No