FDA Orange Book · active-ingredient family
Guanfacine hydrochloride
Guanfacine hydrochloride is approved as 2 brand and 25 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:INTUNIV · NDA 022037
2
Brand (NDA)
25
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet, tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| INTUNIVRLD×4 | TAKEDA PHARMS USA | NDA 022037 | AB | Sep 02, 2009 | |
| TENEXRLD×3 | PROMIUS PHARMA | NDA 019032 | — | Oct 27, 1986 |
Generic (ANDA) products (25)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| GUANFACINE HYDROCHLORIDE×2 | ASCENT PHARMS INC | ANDA 220675 | AB | Mar 24, 2026 | |
| GUANFACINE HYDROCHLORIDE×4 | RUBICON RESEARCH | ANDA 219689 | AB | Apr 15, 2025 | |
| GUANFACINE HYDROCHLORIDE×4 | UNICHEM | ANDA 219033 | AB | Nov 19, 2024 | |
| GUANFACINE HYDROCHLORIDE×4 | FOSUN WANBANG | ANDA 217638 | AB | Jun 12, 2024 | |
| GUANFACINE HYDROCHLORIDE×2 | XIROMED | ANDA 218326 | AB | Feb 23, 2024 | |
| GUANFACINE HYDROCHLORIDE×2 | RUBICON RESEARCH | ANDA 216762 | AB | Oct 17, 2023 | |
| GUANFACINE HYDROCHLORIDE×2 | I 3 PHARMS | ANDA 216828 | AB | Oct 05, 2023 | |
| GUANFACINE HYDROCHLORIDE×4 | ALEMBIC | ANDA 217269 | AB | Aug 07, 2023 | |
| GUANFACINE HYDROCHLORIDE×2 | AJANTA PHARMA LTD | ANDA 217293 | AB | Apr 27, 2023 | |
| GUANFACINE HYDROCHLORIDE×2 | AIPING PHARM INC | ANDA 216399 | AB | Jun 08, 2022 | |
| GUANFACINE HYDROCHLORIDE×2 | UNICHEM | ANDA 214689 | AB | Mar 03, 2021 | |
| GUANFACINE HYDROCHLORIDE×4 | YICHANG HUMANWELL | ANDA 213428 | AB | Nov 25, 2020 | |
| GUANFACINE HYDROCHLORIDE×4 | APOTEX | ANDA 205430 | AB | Jul 25, 2018 | |
| GUANFACINE HYDROCHLORIDE×4 | SUN PHARM | ANDA 205689 | — | Nov 16, 2017 | |
| GUANFACINE HYDROCHLORIDE×4 | IMPAX LABS INC | ANDA 202238 | — | Oct 20, 2015 | |
| GUANFACINE HYDROCHLORIDE×4 | SANDOZ | ANDA 202568 | AB | Jun 03, 2015 | |
| GUANFACINE HYDROCHLORIDE×4 | PHARMOBEDIENT | ANDA 202578 | — | Jun 02, 2015 | |
| GUANFACINE HYDROCHLORIDE×4 | TEVA PHARMS USA | ANDA 201382 | AB | Jun 02, 2015 | |
| GUANFACINE HYDROCHLORIDE×4 | TWI PHARMS | ANDA 201408 | AB | Jun 02, 2015 | |
| GUANFACINE HYDROCHLORIDE×4 | ACTAVIS ELIZABETH | ANDA 200881 | AB | Oct 05, 2012 | |
| GUANFACINE HYDROCHLORIDE×2 | AMNEAL PHARM | ANDA 075109 | AB | Nov 25, 1998 | |
| GUANFACINE HYDROCHLORIDE×2 | WATSON LABS | ANDA 074762 | — | Jun 25, 1997 | |
| GUANFACINE HYDROCHLORIDE×2 | EPIC PHARMA LLC | ANDA 074673 | AB | Feb 28, 1997 | |
| GUANFACINE HYDROCHLORIDE×2 | AUROBINDO PHARMA USA | ANDA 074796 | AB | Jan 27, 1997 | |
| GUANFACINE HYDROCHLORIDE×2 | WATSON LABS | ANDA 074145 | AB | Oct 17, 1995 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Guanfacine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
