FDA Orange Book · active-ingredient family
Mycophenolate mofetil hydrochloride
Mycophenolate mofetil hydrochloride is approved as 1 brand and 8 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:CELLCEPT · NDA 050758
1
Brand (NDA)
8
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CELLCEPTRLD | ROCHE PALO | NDA 050758 | AP | Aug 12, 1998 |
Generic (ANDA) products (8)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MYCOPHENOLATE MOFETIL HYDROCHLORIDE | BPI LABS | ANDA 214283 | AP | Jun 01, 2023 | |
| MYCOPHENOLATE MOFETIL HYDROCHLORIDE | ONESOURCE SPECIALTY | ANDA 216390 | AP | Dec 23, 2022 | |
| MYCOPHENOLATE MOFETIL HYDROCHLORIDE | AMNEAL | ANDA 211374 | — | Mar 05, 2021 | |
| MYCOPHENOLATE MOFETIL HYDROCHLORIDE | MEITHEAL | ANDA 212130 | AP | Jan 15, 2021 | |
| MYCOPHENOLATE MOFETIL HYDROCHLORIDE | ZYDUS PHARMS | ANDA 204473 | AP | Aug 31, 2017 | |
| MYCOPHENOLATE MOFETIL HYDROCHLORIDE | MYLAN LABS LTD | ANDA 203859 | AP | Mar 31, 2017 | |
| MYCOPHENOLATE MOFETIL HYDROCHLORIDE | RISING | ANDA 204043 | AP | Feb 28, 2017 | |
| MYCOPHENOLATE MOFETIL HYDROCHLORIDE | PH HEALTH | ANDA 203575 | AP | Oct 28, 2016 |
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.
Mycophenolate mofetil hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
