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Generated: June 23, 2017
What are the generic drug sources for guanfacine hydrochloride and what is the scope of guanfacine hydrochloride patent protection?
Guanfacine hydrochloride is the generic ingredient in three branded drugs marketed by Twi Pharms Inc, Amneal Pharm, Promius Pharma, Shire, Impax Labs Inc, Watson Labs, Sandoz Inc, Epic Pharma Llc, Mylan Pharms Inc, Actavis Elizabeth, Teva Pharms Usa, and Mylan, and is included in thirteen NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.| Tradenames: | 3 |
| Patents: | 3 |
| Applicants: | 12 |
| NDAs: | 13 |
| Drug Master File Entries: see list | 7 |
| Suppliers / Packagers: see list | 24 |
| Bulk Api Vendors: see list | 43 |
| Clinical Trials: see list | 2,284 |
| Patent Applications: see list | 771 |
| Therapeutic Class: | Cardiovascular Agents |
| Drug Prices: | see low prices |
| DailyMed Link: | guanfacine hydrochloride at DailyMed |
| Drug Class | Central alpha-2 Adrenergic Agonist |
| Mechanism of Action | Adrenergic alpha2-Agonists |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Teva Pharms Usa | GUANFACINE HYDROCHLORIDE | guanfacine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 201382-002 | Jun 2, 2015 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Teva Pharms Usa | GUANFACINE HYDROCHLORIDE | guanfacine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 201382-004 | Jun 2, 2015 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Impax Labs Inc | GUANFACINE HYDROCHLORIDE | guanfacine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 202238-001 | Oct 20, 2015 | DISCN | No | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
Actavis Elizabeth | GUANFACINE HYDROCHLORIDE | guanfacine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200881-004 | Oct 5, 2012 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Actavis Elizabeth | GUANFACINE HYDROCHLORIDE | guanfacine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200881-002 | Oct 5, 2012 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Shire | INTUNIV | guanfacine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022037-001 | Sep 2, 2009 | 5,854,290*PED | ► Subscribe | ||||||||||||||||||||||
Promius Pharma | TENEX | guanfacine hydrochloride | TABLET;ORAL | 019032-001 | Oct 27, 1986 | 3,632,645 | ► Subscribe | ||||||||||||||||||||||
Shire | INTUNIV | guanfacine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022037-004 | Sep 2, 2009 | 5,854,290*PED | ► Subscribe | ||||||||||||||||||||||
Promius Pharma | TENEX | guanfacine hydrochloride | TABLET;ORAL | 019032-003 | Nov 7, 1988 | 3,632,645 | ► Subscribe | ||||||||||||||||||||||
Shire | INTUNIV | guanfacine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022037-002 | Sep 2, 2009 | 5,854,290*PED | ► Subscribe | ||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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