Guanfacine hydrochloride - Generic Drug Details

✉ Email this page to a colleague

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, Norvium Bioscience, Sandoz, Sun Pharm, Teva Pharms Usa, Twi Pharms, Wanbang Biopharms, Yichang Humanwell, Takeda Pharms Usa, Ajanta Pharma Ltd, Amneal Pharm, Aurobindo Pharma Usa, Epic Pharma Llc, I 3 Pharms, Rubicon, Unichem, Watson Labs, Xiromed, and Promius Pharma, and is included in twenty-four NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for guanfacine hydrochloride. Thirty-four suppliers are listed for this compound.

Summary for guanfacine hydrochloride

US Patents:	0
Tradenames:	3
Applicants:	22
NDAs:	24
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	34
Raw Ingredient (Bulk) Api Vendors:	110
Clinical Trials:	69
Patent Applications:	1,234
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
The Emmes Company, LLC	Phase 2
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 2
Rachel G. Greenberg, MD, MB, MHS	Phase 2

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

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Xiromed	GUANFACINE HYDROCHLORIDE	guanfacine hydrochloride	TABLET;ORAL	218326-002	Feb 23, 2024	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Twi Pharms	GUANFACINE HYDROCHLORIDE	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	201408-001	Jun 2, 2015	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
I 3 Pharms	GUANFACINE HYDROCHLORIDE	guanfacine hydrochloride	TABLET;ORAL	216828-001	Oct 5, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Impax Labs Inc	GUANFACINE HYDROCHLORIDE	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	202238-001	Oct 20, 2015		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Unichem	GUANFACINE HYDROCHLORIDE	guanfacine hydrochloride	TABLET;ORAL	214689-001	Mar 3, 2021	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Promius Pharma	TENEX	guanfacine hydrochloride	TABLET;ORAL	019032-001	Oct 27, 1986	⤷ Sign Up	⤷ Sign Up
Takeda Pharms Usa	INTUNIV	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022037-004	Sep 2, 2009	⤷ Sign Up	⤷ Sign Up
Takeda Pharms Usa	INTUNIV	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022037-001	Sep 2, 2009	⤷ Sign Up	⤷ Sign Up
Takeda Pharms Usa	INTUNIV	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022037-002	Sep 2, 2009	⤷ Sign Up	⤷ Sign Up
Takeda Pharms Usa	INTUNIV	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022037-002	Sep 2, 2009	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.