FDA Orange Book · active-ingredient family
Mycophenolate mofetil
Mycophenolate mofetil is approved as 4 brand and 42 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:MYHIBBIN · NDA 216482
4
Brand (NDA)
42
Generics (ANDA)
5
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, for suspension, suspension, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MYHIBBINRLD | AZURITY | NDA 216482 | — | May 01, 2024 | |
| CELLCEPTRLD | ROCHE PALO | NDA 050759 | AB | Oct 01, 1998 | |
| CELLCEPTRLD | ROCHE PALO | NDA 050723 | AB | Jun 19, 1997 | |
| CELLCEPTRLD | ROCHE PALO | NDA 050722 | AB | May 03, 1995 |
Generic (ANDA) products (42)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MYCOPHENOLATE MOFETIL | CONCORD BIOTECH LTD | ANDA 218566 | AB | Jun 01, 2026 | |
| MYCOPHENOLATE MOFETIL | WUXI | ANDA 214079 | AB | Nov 07, 2024 | |
| MYCOPHENOLATE MOFETIL | HETERO LABS LTD V | ANDA 207022 | AB | Oct 22, 2024 | |
| MYCOPHENOLATE MOFETIL | HETERO LABS LTD V | ANDA 208119 | AB | Oct 22, 2024 | |
| MYCOPHENOLATE MOFETIL | AUROBINDO PHARMA LTD | ANDA 218227 | AB | Sep 26, 2024 | |
| MYCOPHENOLATE MOFETIL | AUROBINDO PHARMA | ANDA 217937 | AB | Feb 20, 2024 | |
| MYCOPHENOLATE MOFETIL | AUROBINDO PHARMA LTD | ANDA 217828 | AB | Jan 05, 2024 | |
| MYCOPHENOLATE MOFETIL | RISING | ANDA 213955 | AB | Sep 11, 2023 | |
| MYCOPHENOLATE MOFETIL | STRIDES PHARMA INTL | ANDA 212634 | AB | Aug 29, 2023 | |
| MYCOPHENOLATE MOFETIL | TEVA PHARMS USA | ANDA 211272 | — | Jan 25, 2022 | |
| MYCOPHENOLATE MOFETIL | AMNEAL | ANDA 214871 | AB | Nov 02, 2021 | |
| MYCOPHENOLATE MOFETIL | LANNETT CO INC | ANDA 214525 | AB | Jul 29, 2021 | |
| MYCOPHENOLATE MOFETIL | CONCORD BIOTECH LTD | ANDA 212087 | AB | Jul 31, 2020 | |
| MYCOPHENOLATE MOFETIL | VISTAPHARM LLC | ANDA 210370 | AB | Feb 12, 2019 | |
| MYCOPHENOLATE MOFETIL | CONCORD BIOTECH LTD | ANDA 210181 | AB | Jan 08, 2019 | |
| MYCOPHENOLATE MOFETIL | ZHEJIANG HISUN PHARM | ANDA 204076 | AB | Nov 16, 2017 | |
| MYCOPHENOLATE MOFETIL | ZHEJIANG HISUN PHARM | ANDA 204077 | AB | Nov 13, 2017 | |
| MYCOPHENOLATE MOFETIL | JUBILANT CADISTA | ANDA 090762 | — | Dec 15, 2014 | |
| MYCOPHENOLATE MOFETIL | JUBILANT CADISTA | ANDA 090661 | — | Dec 15, 2014 | |
| MYCOPHENOLATE MOFETIL | ALKEM LABS LTD | ANDA 203005 | AB | Nov 14, 2014 | |
| MYCOPHENOLATE MOFETIL | ALKEM LABS LTD | ANDA 200197 | AB | Jun 13, 2013 | |
| MYCOPHENOLATE MOFETIL | ALKEM LABS LTD | ANDA 091249 | AB | Nov 04, 2011 | |
| MYCOPHENOLATE MOFETIL | DR REDDYS LABS LTD | ANDA 091315 | — | Oct 27, 2011 | |
| MYCOPHENOLATE MOFETIL | DR REDDYS LABS LTD | ANDA 090464 | — | Sep 13, 2010 | |
| MYCOPHENOLATE MOFETIL | AMNEAL | ANDA 090606 | — | Jul 16, 2010 | |
| MYCOPHENOLATE MOFETIL | STRIDES PHARMA | ANDA 090055 | AB | Jun 10, 2010 | |
| MYCOPHENOLATE MOFETIL | STRIDES PHARMA | ANDA 090456 | AB | Jun 10, 2010 | |
| MYCOPHENOLATE MOFETIL | STRIDES PHARMA INTL | ANDA 090111 | — | Dec 22, 2009 | |
| MYCOPHENOLATE MOFETIL | TEVA PHARMS | ANDA 065491 | AB | May 06, 2009 | |
| MYCOPHENOLATE MOFETIL | ACCORD HLTHCARE | ANDA 090253 | AB | May 04, 2009 | |
| MYCOPHENOLATE MOFETIL | MYLAN | ANDA 065520 | — | May 04, 2009 | |
| MYCOPHENOLATE MOFETIL | ZYDUS PHARMS USA INC | ANDA 065433 | — | May 04, 2009 | |
| MYCOPHENOLATE MOFETIL | ACCORD HLTHCARE | ANDA 065416 | AB | May 04, 2009 | |
| MYCOPHENOLATE MOFETIL | MYLAN | ANDA 065521 | AB | May 04, 2009 | |
| MYCOPHENOLATE MOFETIL | TEVA PHARMS | ANDA 065457 | — | May 04, 2009 | |
| MYCOPHENOLATE MOFETIL | ZYDUS PHARMS USA INC | ANDA 065477 | — | May 04, 2009 | |
| MYCOPHENOLATE MOFETIL | APOTEX CORP | ANDA 090419 | — | Apr 22, 2009 | |
| MYCOPHENOLATE MOFETIL | APOTEX | ANDA 090499 | — | Apr 22, 2009 | |
| MYCOPHENOLATE MOFETIL | SANDOZ | ANDA 065379 | AB | Oct 15, 2008 | |
| MYCOPHENOLATE MOFETIL | SANDOZ | ANDA 065451 | AB | Oct 15, 2008 | |
| MYCOPHENOLATE MOFETIL | HIKMA | ANDA 065410 | AB | Jul 29, 2008 | |
| MYCOPHENOLATE MOFETIL | HIKMA | ANDA 065413 | AB | Jul 29, 2008 |
Listed patents (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| 12194143 | Aug 16, 2039 | in 13 yr 4 mo | ProductU-1752 |
| 12097285 | Aug 16, 2039 | in 13 yr 4 mo | ProductU-1752 |
| 12226526 | Aug 16, 2039 | in 13 yr 4 mo | ProductU-1752 |
| 11931455 | Aug 16, 2039 | in 13 yr 4 mo | ProductU-1752 |
| 12097284 | Aug 16, 2039 | in 13 yr 4 mo | Product |
Mycophenolate mofetil — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
