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Last Updated: March 29, 2024

INTUNIV Drug Patent Profile


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When do Intuniv patents expire, and what generic alternatives are available?

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-two 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

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

SponsorPhase
Maimonides Medical CenterPhase 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
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

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Takeda Pharms Usa INTUNIV guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022037-004 Sep 2, 2009 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Takeda Pharms Usa INTUNIV guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022037-002 Sep 2, 2009 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Takeda Pharms Usa INTUNIV guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022037-003 Sep 2, 2009 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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
Takeda Pharms Usa INTUNIV guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022037-004 Sep 2, 2009 ⤷  Try a Trial ⤷  Try a Trial
Takeda Pharms Usa INTUNIV guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022037-001 Sep 2, 2009 ⤷  Try a Trial ⤷  Try a Trial
Takeda Pharms Usa INTUNIV guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022037-004 Sep 2, 2009 ⤷  Try a Trial ⤷  Try a Trial
Takeda Pharms Usa INTUNIV guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022037-002 Sep 2, 2009 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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