FDA Orange Book · active-ingredient family
Mycophenolate sodium
Mycophenolate sodium is approved as 1 brand and 12 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:MYFORTIC · NDA 050791
1
Brand (NDA)
12
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet, delayed release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MYFORTICRLD×2 | NOVARTIS | NDA 050791 | AB | Feb 27, 2004 |
Generic (ANDA) products (12)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MYCOPHENOLATE SODIUM×2 | FOSUN WANBANG | ANDA 216637 | AB | May 29, 2024 | |
| MYCOPHENOLATE SODIUM×2 | AUROBINDO PHARMA LTD | ANDA 218603 | AB | Feb 27, 2024 | |
| MYCOPHENOLATE SODIUM×2 | BIOCON PHARMA | ANDA 217031 | AB | Nov 29, 2023 | |
| MYCOPHENOLATE SODIUM×2 | BIOCON PHARMA | ANDA 214630 | AB | Nov 29, 2021 | |
| MYCOPHENOLATE SODIUM×2 | TWI PHARMS | ANDA 214289 | — | Nov 03, 2021 | |
| MYCOPHENOLATE SODIUM×2 | ALKEM LABS LTD | ANDA 208315 | AB | Sep 23, 2021 | |
| MYCOPHENOLATE SODIUM×2 | YICHANG HUMANWELL | ANDA 214376 | AB | Feb 10, 2021 | |
| MYCOPHENOLATE SODIUM×2 | CONCORD BIOTECH LTD | ANDA 211173 | AB | Dec 13, 2019 | |
| MYCOPHENOLATE SODIUM×2 | ACCORD HLTHCARE | ANDA 202555 | AB | Aug 23, 2017 | |
| MYCOPHENOLATE SODIUM×2 | TEVA PHARMS USA | ANDA 202720 | — | Oct 30, 2014 | |
| MYCOPHENOLATE SODIUM×2 | RK PHARMA | ANDA 091248 | — | Jan 08, 2014 | |
| MYCOPHENOLATE SODIUM×2 | APOTEX INC | ANDA 091558 | AB | Aug 21, 2012 |
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 sodium — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
