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Guanfacine hydrochloride - Generic Drug Details

What are the generic drug sources for guanfacine hydrochloride and what is the scope of guanfacine hydrochloride patent protection?
Guanfacine hydrochloride is the generic ingredient in three branded drugs marketed by Actavis Elizabeth, Impax Labs Inc, Mylan Pharms Inc, Sandoz Inc, Sun Pharm Inds Ltd, Teva Pharms Usa, Twi Pharms Inc, Shire, Amneal Pharm, Epic Pharma Llc, Mylan, Watson Labs, and Promius Pharma, and is included in fourteen 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-five suppliers are listed for this compound.

Summary for guanfacine hydrochloride

International Patents:	10
US Patents:	2
Tradenames:	3
Applicants:	13
NDAs:	14
Drug Master File Entries:	7
Suppliers / Packagers:	25
Bulk Api Vendors:	58
Clinical Trials:	55
Patent Applications:	830
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for guanfacine hydrochloride
DailyMed Link:	guanfacine hydrochloride at DailyMed

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
AK105076
AKOS015966858
AKOS030242245
ANW-70740
API0006740
AS-12253
AX8239284
BC202678
Benzeneacetamide, N-(aminoiminomethyl)-2,6-dichloro-, hydrochloride (1:1)
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
CS-1254
CTK8C3871
CTK8G0106
D00606
D0WD8M
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; traceable to USP
Guanfacine hydrochloride, United States Pharmacopeia (USP) Reference Standard
GUANFACINEHCL
GuanfacineHydrochloride
Guanfascine Hydrochloride
Guarfacine Hydrochloride
HMS1569C19
HY-17416
Intuniv
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
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 Inc	GUANFACINE HYDROCHLORIDE	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	201408-003	Jun 2, 2015	AB	RX	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Sun Pharm Inds Ltd	GUANFACINE HYDROCHLORIDE	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205689-002	Nov 16, 2017	AB	RX	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Twi Pharms Inc	GUANFACINE HYDROCHLORIDE	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	201408-002	Jun 2, 2015	AB	RX	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Actavis Elizabeth	GUANFACINE HYDROCHLORIDE	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200881-004	Oct 5, 2012	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

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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	➤ Sign Up	➤ Sign Up
Promius Pharma	TENEX	guanfacine hydrochloride	TABLET;ORAL	019032-001	Oct 27, 1986	➤ Sign Up	➤ Sign Up
Promius Pharma	TENEX	guanfacine hydrochloride	TABLET;ORAL	019032-003	Nov 7, 1988	➤ Sign Up	➤ Sign Up
Promius Pharma	TENEX	guanfacine hydrochloride	TABLET;ORAL	019032-002	Nov 7, 1988	➤ Sign Up	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration