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, Alembic, Apotex, Impax Labs Inc, Norvium Bioscience, Sandoz, Sun Pharm, Teva Pharms Usa, Twi Pharms, Wanbang Biopharms, Yichang Humanwell, Takeda Pharms Usa, Ajanta Pharma Ltd, Amneal Pharm, Aurobindo Pharma Usa, Epic Pharma Llc, I 3 Pharms, Rubicon, Unichem, Watson Labs, Xiromed, and Promius Pharma, and is included in twenty-four NDAs. Additional information is available in the individual branded drug profile pages.There are six drug master file entries for guanfacine hydrochloride. Thirty-four suppliers are listed for this compound.
Summary for GUANFACINE HYDROCHLORIDE
| US Patents: | 0 |
| Tradenames: | 3 |
| Applicants: | 22 |
| NDAs: | 24 |
| Drug Master File Entries: | 6 |
| Finished Product Suppliers / Packagers: | 34 |
| Raw Ingredient (Bulk) Api Vendors: | 110 |
| Clinical Trials: | 69 |
| Patent Applications: | 1,234 |
| 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 |
|---|---|
| The Emmes Company, LLC | Phase 2 |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Phase 2 |
| Rachel G. Greenberg, MD, MB, MHS | Phase 2 |
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
Anatomical Therapeutic Chemical (ATC) Classes for GUANFACINE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for GUANFACINE HYDROCHLORIDE
| 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 GUANFACINE HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Apotex | GUANFACINE HYDROCHLORIDE | guanfacine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205430-003 | Jul 25, 2018 | AB | RX | No | No | ⤷ 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 | |||
| Wanbang Biopharms | GUANFACINE HYDROCHLORIDE | guanfacine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 217638-002 | Jun 12, 2024 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Watson Labs | GUANFACINE HYDROCHLORIDE | guanfacine hydrochloride | TABLET;ORAL | 074762-002 | Jun 25, 1997 | DISCN | No | 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 | |||
| Teva Pharms Usa | GUANFACINE HYDROCHLORIDE | guanfacine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 201382-001 | Jun 2, 2015 | AB | RX | No | 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 GUANFACINE HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Promius Pharma | TENEX | guanfacine hydrochloride | TABLET;ORAL | 019032-001 | Oct 27, 1986 | ⤷ 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 | 022037-002 | Sep 2, 2009 | ⤷ Sign Up | ⤷ Sign Up |
| 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 | 022037-003 | Sep 2, 2009 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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.
ISSN: 2162-2639
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