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-four 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.
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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 |
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 | 022037-004 | 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 | 022037-003 | 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 | 022037-003 | 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 | 2004518676 | ⤷ Sign Up | |
| Portugal | 1351668 | ⤷ Sign Up | |
| Canada | 2432178 | 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 |
| Israel | 129460 | ⤷ Sign Up | |
| Australia | 2002249881 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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