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Generated: August 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 two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.| Tradenames: | 3 |
| Patents: | 2 |
| Applicants: | 12 |
| NDAs: | 13 |
| Drug Master File Entries: see list | 7 |
| Suppliers / Packagers: see list | 25 |
| Bulk Api Vendors: see list | 43 |
| Clinical Trials: see list | 2,299 |
| 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 | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Actavis Elizabeth | GUANFACINE HYDROCHLORIDE | guanfacine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200881-003 | Oct 5, 2012 | AB | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Actavis Elizabeth | GUANFACINE HYDROCHLORIDE | guanfacine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200881-001 | Oct 5, 2012 | AB | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Impax Labs Inc | GUANFACINE HYDROCHLORIDE | guanfacine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 202238-003 | Oct 20, 2015 | DISCN | No | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Epic Pharma Llc | GUANFACINE HYDROCHLORIDE | guanfacine hydrochloride | TABLET;ORAL | 074673-001 | Feb 28, 1997 | AB | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Impax Labs Inc | GUANFACINE HYDROCHLORIDE | guanfacine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 202238-002 | Oct 20, 2015 | DISCN | No | No | ► Subscribe | ► 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 | 022037-002 | Sep 2, 2009 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Promius Pharma | TENEX | guanfacine hydrochloride | TABLET;ORAL | 019032-001 | Oct 27, 1986 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Shire | INTUNIV | guanfacine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022037-004 | Sep 2, 2009 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Promius Pharma | TENEX | guanfacine hydrochloride | TABLET;ORAL | 019032-003 | Nov 7, 1988 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Shire | INTUNIV | guanfacine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022037-003 | Sep 2, 2009 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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 verifification 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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