FDA Orange Book
Generic for Cuprimine
Cuprimine contains penicillamine. 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 Cuprimine is penicillamine. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 Cuprimine products the Orange Book lists.
Run it in Rivvi
Map Cuprimine and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Cuprimine products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 125MG | Discontinued | None | 0 | None |
| capsule, oral | 250MG | Marketed (Rx) | AB | 7 | AB |
NDA 019853, held by VALEANT PHARMACEUTICALS INTERNATIONAL. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic penicillamine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| WATSON LABORATORIES INC | 210976 | AB (A-rated, therapeutically equivalent) | June 24, 2019 | 250MG |
| PH HEALTH LTD | 211231 | AB (A-rated, therapeutically equivalent) | December 23, 2019 | 250MG |
| DR REDDYS LABORATORIES LTD | 211867 | AB (A-rated, therapeutically equivalent) | August 4, 2020 | 250MG |
| GRANULES PHARMACEUTICALS INC | 211735 | AB (A-rated, therapeutically equivalent) | December 2, 2020 | 250MG |
| INVAGEN PHARMACEUTICALS INC | 213293 | AB (A-rated, therapeutically equivalent) | August 19, 2021 | 250MG |
| BRECKENRIDGE PHARMACEUTICAL INC | 215409 | AB (A-rated, therapeutically equivalent) | August 23, 2021 | 250MG |
| NAVINTA LLC | 214363 | AB (A-rated, therapeutically equivalent) | October 8, 2021 | 250MG |
Cuprimine NDC codes
Questions
Is there a generic for Cuprimine?
Yes. The generic name for Cuprimine is penicillamine. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 Cuprimine products the Orange Book lists.
What is the generic name for Cuprimine?
The active ingredient in Cuprimine is penicillamine, 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.