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Last Updated: October 22, 2019

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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 Inc, Impax Labs Inc, Mylan, Sandoz Inc, Sun Pharm, Teva Pharms Usa, Twi Pharms, Shire, 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. Twenty-one 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:	21
Bulk Api Vendors:	62
Clinical Trials:	61
Patent Applications:	918
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

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Sponsor	Phase
Winthrop University Hospital	Phase 4
NYU Langone Health	Phase 4
Vanderbilt University Medical Center	Phase 2

See all guanfacine hydrochloride clinical trials

Recent Litigation for guanfacine hydrochloride

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Shire LLC v. Apotex, Inc.	2013-11-21
Shire LLC v. Sandoz Inc.	2012-01-06
Shire LLC v. Sandoz Inc.	2011-04-27

See all guanfacine hydrochloride litigation

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

Synonyms for guanfacine hydrochloride

[(2,6-Dichlorophenyl)acetyl]guanidine Hydrochloride
29110-47-2 (Parent)
29110-48-3
29520-14-7
A826918
AB0011596
AC1L2G3E
AC1Q3P39
AKOS015966858
AKOS030242245
ANW-70740
API0006740
AS-12253
AX8239284
BC202678
BCP21710
Benzeneacetamide, N-(aminoiminomethyl)-2,6-dichloro-, monohydrochloride
BG0397
BS 100-141
BS-100-141
C9H10Cl3N3O
C9H9Cl2N3O.HCl
CAS-29520-14-7
CCG-213439
CCG-220339
CHEBI:5559
CHEMBL1200494
Connexyn
CTK8C3871
CTK8G0106
D00606
DSSTox_CID_25157
DSSTox_GSID_45157
DSSTox_RID_80708
DTXSID2045157
EINECS 249-443-3
Estulic
EU-0100519
FT-0630546
FT-0698181
G 1043
G0414
Guanfacin
Guanfacin hydrochloride
Guanfacine (hydrochloride)
GUANFACINE HCL
Guanfacine hydrochloride (JAN/USP)
Guanfacine hydrochloride [USAN:JAN]
Guanfacine hydrochloride [USAN:USP:JAN]
Guanfacine hydrochloride, >=98% (HPLC)
Guanfacine hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material
Guanfacine hydrochloride, United States Pharmacopeia (USP) Reference Standard
GuanfacineHydrochloride
Guanfascine Hydrochloride
Guarfacine Hydrochloride
HMS1569C19
Intuniv
Intuniv (TN)
J-017395
KB-258655
KS-000017QB
LON 798
LP00519
LS-28474
MFCD00798230
MLS000069745
MLS001077329
MLS002222252
MolPort-003-666-686
MolPort-019-997-499
N (Aminoiminomethyl)-2,6-dichlorobenzeneacetamide
N-(aminoiminomethyl)-2,6-dichloro-benzeneacetamide hydrochloride
N-(Aminoiminomethyl)-2,6-dichlorobenzeneacetamide hydrochloride
N-(Aminoiminomethyl)-2,6-dichlorophenylacetamide monohydrochloride
N-(diaminomethylidene)-2-(2,6-dichlorophenyl)acetamide hydrochloride
N-[bis(azanyl)methylidene]-2-[2,6-bis(chloranyl)phenyl]ethanamide hydrochloride
N-Amidino-2-(2,6-dichlorophenyl)acetamide hydrochloride
N-Amidino-2-(2,6-dichlorophenyl)acetamide monohydrochloride
N-Carbamimidoyl-2-(2,6-dichlorophenyl)acetamide hydrochloride
n-carbamimidoyl-2-(2,6-dichlorphenyl)acetamidhydrochlorid
NCGC00015469-05
NCGC00015469-09
NCGC00093914-01
NCGC00093914-02
NCGC00180965-01
NCGC00261204-01
NSC-759121
NSC759121
Opera_ID_1928
Pharmakon1600-01505435
PML56A160O
Prestwick_740
S-877503
s4693
SCHEMBL15603414
SCHEMBL41681
SMR000058453
SPD 503
SPD-503
SPD503
SR-01000075893
SR-01000075893-1
SR-01000075893-3
SR-01000075893-6
TC-159485
Tenex
Tenex (TN)
Tox21_110159
Tox21_110159_1
Tox21_500519
UNII-PML56A160O
W-5123

US Patents and Regulatory Information for guanfacine hydrochloride

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Twi Pharms	GUANFACINE HYDROCHLORIDE	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	201408-004	Jun 2, 2015	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Twi Pharms	GUANFACINE HYDROCHLORIDE	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	201408-001	Jun 2, 2015	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Impax Labs Inc	GUANFACINE HYDROCHLORIDE	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	202238-003	Oct 20, 2015		DISCN	No	No	Start Trial	Start Trial				Start Trial
>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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Shire	INTUNIV	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022037-001	Sep 2, 2009	Start Trial	Start Trial
Promius Pharma	TENEX	guanfacine hydrochloride	TABLET;ORAL	019032-002	Nov 7, 1988	Start Trial	Start Trial
Shire	INTUNIV	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022037-004	Sep 2, 2009	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for guanfacine hydrochloride

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Country	Patent Number	Estimated Expiration
Japan	4340840	Start Trial
Denmark	1351668	Start Trial
Japan	2004518676	Start Trial
>Country	>Patent Number	>Estimated Expiration

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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 verifification 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.

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