GUANFACINE HYDROCHLORIDE Drug Patent Profile
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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, Mylan, Sandoz, Sun Pharm, Teva Pharms Usa, Twi Pharms, 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-one NDAs.
The generic ingredient in GUANFACINE HYDROCHLORIDE is guanfacine hydrochloride. There are seven drug master file entries for this compound. Thirty-two 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.
Summary for GUANFACINE HYDROCHLORIDE
US Patents: | 0 |
Applicants: | 19 |
NDAs: | 21 |
Finished Product Suppliers / Packagers: | 31 |
Raw Ingredient (Bulk) Api Vendors: | 110 |
Clinical Trials: | 68 |
Patent Applications: | 3,182 |
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 |
---|---|
New York State Psychiatric Institute | Phase 2 |
Elkana Kohn | Phase 2 |
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
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Ajanta Pharma Ltd | GUANFACINE HYDROCHLORIDE | guanfacine hydrochloride | TABLET;ORAL | 217293-001 | Apr 27, 2023 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Teva Pharms Usa | GUANFACINE HYDROCHLORIDE | guanfacine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 201382-004 | Jun 2, 2015 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
I 3 Pharms | GUANFACINE HYDROCHLORIDE | guanfacine hydrochloride | TABLET;ORAL | 216828-001 | Oct 5, 2023 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Watson Labs | GUANFACINE HYDROCHLORIDE | guanfacine hydrochloride | TABLET;ORAL | 074762-002 | Jun 25, 1997 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |