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Guanfacine hydrochloride - Generic Drug Details
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What are the generic drug sources for guanfacine hydrochloride and what is the scope of patent protection?
Guanfacine hydrochloride
is the generic ingredient in three branded drugs marketed by Actavis Elizabeth, Apotex, Impax Labs Inc, Mylan, Sandoz Inc, Sun Pharm, Teva Pharms Usa, Twi Pharms, Yichang Humanwell, Takeda Pharms Usa, Amneal Pharm, Epic Pharma Llc, Watson Labs, and Promius Pharma, and is included in sixteen NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Guanfacine hydrochloride has ten patent family members in nine countries.
There are seven drug master file entries for guanfacine hydrochloride. Twenty suppliers are listed for this compound.
Summary for guanfacine hydrochloride
International Patents: | 10 |
US Patents: | 2 |
Tradenames: | 3 |
Applicants: | 14 |
NDAs: | 16 |
Drug Master File Entries: | 7 |
Suppliers / Packagers: | 20 |
Bulk Api Vendors: | 90 |
Clinical Trials: | 65 |
Patent Applications: | 942 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for guanfacine hydrochloride |
What excipients (inactive ingredients) are in guanfacine hydrochloride? | guanfacine hydrochloride excipients list |
DailyMed Link: | guanfacine hydrochloride at DailyMed |
Recent Clinical Trials for guanfacine hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Massachusetts General Hospital | Phase 2 |
University of Alabama at Birmingham | N/A |
Stanford University | Phase 4 |
Pharmacology for guanfacine hydrochloride
Drug Class | Central alpha-2 Adrenergic Agonist |
Mechanism of Action | Adrenergic alpha2-Agonists |
Medical Subject Heading (MeSH) Categories for guanfacine hydrochloride
Paragraph IV (Patent) Challenges for GUANFACINE HYDROCHLORIDE
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
INTUNIV | TABLET, EXTENDED RELEASE;ORAL | guanfacine hydrochloride | 022037 | 2009-12-29 |
US Patents and Regulatory Information for guanfacine hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Watson Labs | GUANFACINE HYDROCHLORIDE | guanfacine hydrochloride | TABLET;ORAL | 074762-002 | Jun 25, 1997 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Sun Pharm | GUANFACINE HYDROCHLORIDE | guanfacine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205689-004 | Nov 16, 2017 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Promius Pharma | TENEX | guanfacine hydrochloride | TABLET;ORAL | 019032-002 | Nov 7, 1988 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
Impax Labs Inc | GUANFACINE HYDROCHLORIDE | guanfacine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 202238-002 | Oct 20, 2015 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Sun Pharm | GUANFACINE HYDROCHLORIDE | guanfacine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205689-003 | Nov 16, 2017 | AB | RX | No | No | Start Trial | Start Trial | 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 guanfacine hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Takeda Pharms Usa | INTUNIV | guanfacine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022037-001 | Sep 2, 2009 | Start Trial | Start Trial |
Promius Pharma | TENEX | guanfacine hydrochloride | TABLET;ORAL | 019032-003 | Nov 7, 1988 | Start Trial | Start Trial |
Promius Pharma | TENEX | guanfacine hydrochloride | TABLET;ORAL | 019032-002 | Nov 7, 1988 | Start Trial | Start Trial |
Promius Pharma | TENEX | guanfacine hydrochloride | TABLET;ORAL | 019032-001 | Oct 27, 1986 | Start Trial | Start Trial |
Takeda Pharms Usa | INTUNIV | guanfacine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022037-002 | Sep 2, 2009 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for guanfacine hydrochloride
Country | Patent Number | Estimated Expiration |
---|---|---|
Japan | 2004518676 | Start Trial |
World Intellectual Property Organization (WIPO) | 02058676 | Start Trial |
Spain | 2527854 | Start Trial |
Australia | 2002249881 | Start Trial |
Portugal | 1351668 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
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