GUANFACINE HYDROCHLORIDE Drug Patent Profile
✉ Email this page to a colleague
When do Guanfacine Hydrochloride patents expire, and what generic alternatives are available?
Guanfacine Hydrochloride is a drug marketed by Actavis Elizabeth, Alembic, Apotex, Impax Labs Inc, Norvium Bioscience, Sandoz, Sun Pharm, Teva Pharms Usa, Twi Pharms, Wanbang Biopharms, Yichang Humanwell, Ajanta Pharma Ltd, Amneal Pharm, Aurobindo Pharma Usa, Epic Pharma Llc, I 3 Pharms, Rubicon, Unichem, Watson Labs, and Xiromed. and is included in twenty-two NDAs.
The generic ingredient in GUANFACINE HYDROCHLORIDE 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 Guanfacine Hydrochloride
A generic version of GUANFACINE HYDROCHLORIDE was approved as guanfacine hydrochloride by WATSON LABS on October 17th, 1995.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for GUANFACINE HYDROCHLORIDE?
- What are the global sales for GUANFACINE HYDROCHLORIDE?
- What is Average Wholesale Price for GUANFACINE HYDROCHLORIDE?
Summary for GUANFACINE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 20 |
| NDAs: | 22 |
| Finished Product Suppliers / Packagers: | 33 |
| Raw Ingredient (Bulk) Api Vendors: | 110 |
| Clinical Trials: | 69 |
| Patent Applications: | 823 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for GUANFACINE HYDROCHLORIDE |
| DailyMed Link: | GUANFACINE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for GUANFACINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Rachel G. Greenberg, MD, MB, MHS | Phase 2 |
| The Emmes Company, LLC | Phase 2 |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Yichang Humanwell | GUANFACINE HYDROCHLORIDE | guanfacine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 213428-001 | Nov 25, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Teva Pharms Usa | GUANFACINE HYDROCHLORIDE | guanfacine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 201382-004 | Jun 2, 2015 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Aurobindo Pharma Usa | GUANFACINE HYDROCHLORIDE | guanfacine hydrochloride | TABLET;ORAL | 074796-001 | Jan 27, 1997 | 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 |
