INTUNIV Drug Patent Profile

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

Intuniv is a drug marketed by Takeda Pharms Usa and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Intuniv

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

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Summary for INTUNIV

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	110
Clinical Trials:	29
Patent Applications:	823
Drug Prices:	Drug price information for INTUNIV
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for INTUNIV
What excipients (inactive ingredients) are in INTUNIV?	INTUNIV excipients list
DailyMed Link:	INTUNIV at DailyMed

Drug patent expirations by year for INTUNIV

Recent Clinical Trials for INTUNIV

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Maimonides Medical Center	Phase 4
National Institute on Alcohol Abuse and Alcoholism (NIAAA)	Phase 2
Takeda Development Center Americas, Inc.	Phase 4

See all INTUNIV clinical trials

Pharmacology for INTUNIV

Drug Class	Central alpha-2 Adrenergic Agonist
Mechanism of Action	Adrenergic alpha2-Agonists

Paragraph IV (Patent) Challenges for INTUNIV

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 INTUNIV

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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
Takeda Pharms Usa	INTUNIV	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022037-001	Sep 2, 2009	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Takeda Pharms Usa	INTUNIV	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022037-004	Sep 2, 2009	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Takeda Pharms Usa	INTUNIV	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022037-002	Sep 2, 2009	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Takeda Pharms Usa	INTUNIV	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022037-003	Sep 2, 2009	AB	RX	Yes	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 INTUNIV

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	INTUNIV	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022037-003	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	022037-004	Sep 2, 2009	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for INTUNIV

See the table below for patents covering INTUNIV around the world.

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	1351668	FORMES DE DOSAGE PHARMACEUTIQUE A LIBERATION PROLONGEE POSSEDANT DES PROFILES DE DISSOLUTION A DEPENDANCE AU PH REDUITE AU MINIMUM (SUSTAINED RELEASE PHARMACEUTICAL DOSAGE FORMS WITH MINIMIZED PH DEPENDENT DISSOLUTION PROFILES)	⤷ Sign Up
Denmark	1351668		⤷ Sign Up
Australia	6281298		⤷ Sign Up
World Intellectual Property Organization (WIPO)	02058676		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration