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Last Updated: November 15, 2019

DrugPatentWatch Database Preview

INTUNIV Drug Profile

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Which patents cover Intuniv, and when can generic versions of Intuniv launch?

Intuniv is a drug marketed by Shire and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has ten patent family members in nine countries.

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

Drug patent expirations by year for INTUNIV
Drug Prices for INTUNIV

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Drug Sales Revenue Trends for INTUNIV

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Recent Clinical Trials for INTUNIV

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SponsorPhase
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Phase 2
Daniel ConnorPhase 4
McGill University Health CenterN/A

See all INTUNIV clinical trials

Recent Litigation for INTUNIV

Identify potential future generic entrants

District Court Litigation
Case NameDate
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 INTUNIV litigation

Pharmacology for INTUNIV
Synonyms for INTUNIV
[(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
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 (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
Paragraph IV (Patent) Challenges for INTUNIV
Tradename Dosage Ingredient NDA Submissiondate
INTUNIV TABLET, EXTENDED RELEASE;ORAL guanfacine hydrochloride 022037 2009-12-29

US Patents and Regulatory Information for INTUNIV

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Shire INTUNIV guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022037-001 Sep 2, 2009 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Shire INTUNIV guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022037-004 Sep 2, 2009 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Shire INTUNIV guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022037-002 Sep 2, 2009 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Shire INTUNIV guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022037-004 Sep 2, 2009 AB RX Yes Yes   Start Trial   Start Trial Y   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 INTUNIV

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Shire INTUNIV guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022037-004 Sep 2, 2009   Start Trial   Start Trial
Shire INTUNIV guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022037-001 Sep 2, 2009   Start Trial   Start Trial
Shire INTUNIV guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022037-002 Sep 2, 2009   Start Trial   Start Trial
Shire INTUNIV guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022037-003 Sep 2, 2009   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

McKesson
Moodys
Harvard Business School
Express Scripts
Boehringer Ingelheim
McKinsey

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