INTUNIV Drug Patent Profile
✉ Email this page to a colleague
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-two 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 17th, 1995.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for INTUNIV?
- What are the global sales for INTUNIV?
- What is Average Wholesale Price for INTUNIV?
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 |
![INTUNIV drug patent expirations Drug patent expirations by year for INTUNIV](/p/graph/s/t/INTUNIV-patent-expirations.png)
![Drug Prices for INTUNIV](/p/graph/drug-price/INTUNIV.png)
![Drug Sales Revenue Trends for INTUNIV](/p/graph/drug-sales-revenues/INTUNIV.png)
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 |
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
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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
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 | 022037-001 | Sep 2, 2009 | ⤷ Sign Up | ⤷ Sign Up |
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 | 022037-004 | 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 | 022037-003 | 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.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 4340840 | ⤷ Sign Up | |
Australia | 2002249881 | ⤷ Sign Up | |
Israel | 129460 | ⤷ Sign Up | |
World Intellectual Property Organization (WIPO) | 02058676 | ⤷ Sign Up | |
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 |
Japan | 2001504811 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |