Treats Wilson’s disease, cystinuria. Sold as Cuprimine, Depen. Every FDA application for this active ingredient: 2 branded and 12 generic.
As of Nov 14, 2026, FDA lists 14 applications for Penicillamine (sold as Cuprimine, Depen), first approved Dec 4, 1970, with 0 new uses approved and 0 published complete response letters.
| Penicillamine | Part D | $8.8M | +7% | 253 |
| Cuprimine | Part D | $1.7M | -12% | 0 |
| Trientine Tetrahydrochloride Administered Once a Day for the First Line Treatment of Wilson's Disease Patients.Wilson's Disease · Orphalan | Phase 3 | Recruiting | Mar 12, 2026 |
| Off Treatment Urinary Copper Excretion in Wilson Disease, Pilot StudyWilson Disease · Yale University | — | Recruiting | Dec 24, 2025 |
| Wilson's Disease Treated With D-Penicillamine: Characterization of Skin Damage Secondary to Treatment by Measuring Skin ElasticityWilson Disease, D-Penicillamine · Centre Hospitalier Universitaire de Saint Etienne | Not applicable | Recruiting | Apr 25, 2025 |
| International Wilson's Disease Patient Registry (iWilson Registry)Wilson's Disease · Orphalan | — | Recruiting | Feb 15, 2022 |
| Dec 4, 1970 | CuprimineNDA 19853 · New molecular entity | Valeant Pharms Intl | 12 | Marketed |
| Nov 8, 1978 | DepenNDA 19854 · New formulation or manufacturer | Mylan Speciality LP | 5 | Marketed |
| May 7, 2019 | LuxzylaANDA 209921 | Ani Pharms | 1 | Discontinued |
| Jun 24, 2019 | PenicillamineANDA 210976 | Watson Labs Inc | 0 | Marketed |
| Dec 23, 2019 | PenicillamineANDA 211196 | Ph Health | 0 | Marketed |
| Dec 23, 2019 | PenicillamineANDA 211231 | Ph Health | 0 | Marketed |
| Feb 13, 2020 | PenicillamineANDA 211497 | Teva Pharms USA | 0 | Discontinued |
| Apr 28, 2020 | PenicillamineANDA 213310 | Apotex | 0 | Discontinued |
| Aug 4, 2020 | PenicillamineANDA 211867 | Dr Reddys | 0 | Marketed |
| Nov 30, 2020 | PenicillamineANDA 212933 | Lupin | 0 | Marketed |
| Dec 2, 2020 | PenicillamineANDA 211735 | Granules | 0 | Marketed |
| Aug 19, 2021 | PenicillamineANDA 213293 | Invagen Pharms | 1 | Marketed |
| Aug 23, 2021 | PenicillamineANDA 215409 | Breckenridge | 0 | Marketed |
| Oct 8, 2021 | PenicillamineANDA 214363 | Navinta LLC | 0 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Apotex
Lupin