FDA Orange Book
Generic for Syprine
Syprine contains trientine. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Syprine is trientine. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Syprine products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 250MG | Marketed (Rx) | AB | 7 | AB |
NDA 019194, held by BAUSCH HEALTH AMERICAS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic trientine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| NAVINTA LLC | 211251 | AB (A-rated, therapeutically equivalent) | January 16, 2019 | 250MG |
| ZYDUS PHARMACEUTICALS USA INC | 211554 | AB (A-rated, therapeutically equivalent) | April 26, 2019 | 250MG |
| MSN LABORATORIES PRIVATE LTD | 211134 | AB (A-rated, therapeutically equivalent) | May 22, 2019 | 250MG |
| DR REDDYS LABORATORIES LTD | 211076 | AB (A-rated, therapeutically equivalent) | July 3, 2019 | 250MG |
| RISING PHARMA HOLDINGS INC | 212238 | AB (A-rated, therapeutically equivalent) | February 20, 2020 | 250MG |
| ECI PHARMACEUTICALS LLC | 209945 | AB (A-rated, therapeutically equivalent) | August 13, 2021 | 250MG |
| HETERO LABS LTD UNIT III | 216356 | AB (A-rated, therapeutically equivalent) | June 23, 2022 | 250MG |
Syprine NDC codes
Questions
Is there a generic for Syprine?
Yes. The generic name for Syprine is trientine. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Syprine?
The active ingredient in Syprine is trientine, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.