FDA Orange Book · active-ingredient family
Penicillamine
Penicillamine is approved as 2 brand and 12 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:CUPRIMINE · NDA 019853
2
Brand (NDA)
12
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CUPRIMINERLD×2 | VALEANT PHARMS INTL | NDA 019853 | AB | Approved Prior to Jan 1, 1982 | |
| DEPENRLD | MYLAN SPECIALITY LP | NDA 019854 | AB | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (12)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PENICILLAMINE | NAVINTA LLC | ANDA 214363 | AB | Oct 08, 2021 | |
| PENICILLAMINE | BRECKENRIDGE | ANDA 215409 | AB | Aug 23, 2021 | |
| PENICILLAMINE | INVAGEN PHARMS | ANDA 213293 | AB | Aug 19, 2021 | |
| PENICILLAMINE | GRANULES | ANDA 211735 | AB | Dec 02, 2020 | |
| PENICILLAMINE | LUPIN | ANDA 212933 | AB | Nov 30, 2020 | |
| PENICILLAMINE | DR REDDYS | ANDA 211867 | AB | Aug 04, 2020 | |
| PENICILLAMINE | APOTEX | ANDA 213310 | — | Apr 28, 2020 | |
| PENICILLAMINE | TEVA PHARMS USA | ANDA 211497 | — | Feb 13, 2020 | |
| PENICILLAMINE | PH HEALTH | ANDA 211231 | AB | Dec 23, 2019 | |
| PENICILLAMINE | PH HEALTH | ANDA 211196 | AB | Dec 23, 2019 | |
| PENICILLAMINE | WATSON LABS INC | ANDA 210976 | AB | Jun 24, 2019 | |
| LUXZYLA | ANI PHARMS | ANDA 209921 | — | May 07, 2019 |
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.
Penicillamine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
