FDA Orange Book · active-ingredient family
Trientine hydrochloride
Trientine hydrochloride is approved as 1 brand and 14 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:SYPRINE · NDA 019194
1
Brand (NDA)
14
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SYPRINERLD | BAUSCH | NDA 019194 | AB | Nov 08, 1985 |
Generic (ANDA) products (14)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TRIENTINE HYDROCHLORIDE | HETERO LABS LTD III | ANDA 216356 | AB | Jun 23, 2022 | |
| TRIENTINE HYDROCHLORIDE | ACCORD HLTHCARE | ANDA 212929 | — | Aug 30, 2021 | |
| TRIENTINE HYDROCHLORIDE | ECI PHARMS LLC | ANDA 209945 | AB | Aug 13, 2021 | |
| TRIENTINE HYDROCHLORIDE | LUPIN | ANDA 211637 | — | May 21, 2020 | |
| TRIENTINE HYDROCHLORIDE×2 | RISING | ANDA 212238 | AB | Feb 20, 2020 | |
| CLOVIQUE | CHARTWELL RX | ANDA 209731 | — | Oct 21, 2019 | |
| TRIENTINE HYDROCHLORIDE | PH HEALTH | ANDA 210096 | AB | Sep 25, 2019 | |
| TRIENTINE HYDROCHLORIDE | CHARTWELL RX | ANDA 209415 | — | Sep 16, 2019 | |
| TRIENTINE HYDROCHLORIDE | DR REDDYS | ANDA 211076 | AB | Jul 03, 2019 | |
| TRIENTINE HYDROCHLORIDE | MSN | ANDA 211134 | AB | May 22, 2019 | |
| TRIENTINE HYDROCHLORIDE | ZYDUS PHARMS | ANDA 211554 | AB | Apr 26, 2019 | |
| TRIENTINE HYDROCHLORIDE | AMNEAL | ANDA 210619 | — | Feb 08, 2019 | |
| TRIENTINE HYDROCHLORIDE | NAVINTA LLC | ANDA 211251 | AB | Jan 16, 2019 | |
| TRIENTINE HYDROCHLORIDE | WATSON LABS TEVA | ANDA 207567 | — | Feb 07, 2018 |
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.
Trientine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
