FDA Orange Book · active-ingredient family
Mycophenolate mofetil
Mycophenolate mofetil: 4 brands, 42 generics; first approved May 03, 1995; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 42 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
4
Generics (ANDA)
42
Listed patents
5
Next patent expiry
Aug 16, 2039
in 13 yr
Brand (NDA) products
Originator applications
- AZURITYNDA 2164822024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/ML SUSPENSION ORAL Rx - - ROCHE PALONDA 0507591998
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/ML FOR SUSPENSION ORAL Rx AB - ROCHE PALONDA 0507231997
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Rx AB - ROCHE PALONDA 0507221995
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Rx AB
Generic (ANDA) products (42)
Abbreviated applications
- MYCOPHENOLATE MOFETILCONCORD BIOTECH LTDANDA 2185662026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/ML FOR SUSPENSION ORAL Rx AB - MYCOPHENOLATE MOFETILWUXIANDA 2140792024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Rx AB - MYCOPHENOLATE MOFETILHETERO LABS LTD VANDA 2070222024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Rx AB - MYCOPHENOLATE MOFETILHETERO LABS LTD VANDA 2081192024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Rx AB - MYCOPHENOLATE MOFETILAUROBINDO PHARMA LTDANDA 2182272024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/ML FOR SUSPENSION ORAL Rx AB - MYCOPHENOLATE MOFETILAUROBINDO PHARMAANDA 2179372024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Rx AB - MYCOPHENOLATE MOFETILAUROBINDO PHARMA LTDANDA 2178282024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Rx AB - MYCOPHENOLATE MOFETILRISINGANDA 2139552023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/ML FOR SUSPENSION ORAL Rx AB - MYCOPHENOLATE MOFETILSTRIDES PHARMA INTLANDA 2126342023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/ML FOR SUSPENSION ORAL Rx AB - MYCOPHENOLATE MOFETILTEVA PHARMS USAANDA 2112722022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/ML FOR SUSPENSION ORAL Discontinued - - MYCOPHENOLATE MOFETILAMNEALANDA 2148712021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/ML FOR SUSPENSION ORAL Rx AB - MYCOPHENOLATE MOFETILQUAGENANDA 2145252021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/ML FOR SUSPENSION ORAL Rx AB - MYCOPHENOLATE MOFETILCONCORD BIOTECH LTDANDA 2120872020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Rx AB - MYCOPHENOLATE MOFETILVISTAPHARM LLCANDA 2103702019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/ML FOR SUSPENSION ORAL Rx AB - MYCOPHENOLATE MOFETILCONCORD BIOTECH LTDANDA 2101812019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Rx AB - MYCOPHENOLATE MOFETILZHEJIANG HISUN PHARMANDA 2040762017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Rx AB - MYCOPHENOLATE MOFETILZHEJIANG HISUN PHARMANDA 2040772017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Rx AB - MYCOPHENOLATE MOFETILJUBILANT CADISTAANDA 0907622014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Discontinued - - MYCOPHENOLATE MOFETILJUBILANT CADISTAANDA 0906612014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued - - MYCOPHENOLATE MOFETILALKEM LABS LTDANDA 2030052014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/ML FOR SUSPENSION ORAL Rx AB - MYCOPHENOLATE MOFETILALKEM LABS LTDANDA 2001972013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Rx AB - MYCOPHENOLATE MOFETILALKEM LABS LTDANDA 0912492011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Rx AB - MYCOPHENOLATE MOFETILDR REDDYS LABS LTDANDA 0913152011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Discontinued - - MYCOPHENOLATE MOFETILDR REDDYS LABS LTDANDA 0904642010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued - - MYCOPHENOLATE MOFETILAMNEALANDA 0906062010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued - - MYCOPHENOLATE MOFETILSTRIDES PHARMAANDA 0900552010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Rx AB - MYCOPHENOLATE MOFETILSTRIDES PHARMAANDA 0904562010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Rx AB - MYCOPHENOLATE MOFETILSTRIDES PHARMA INTLANDA 0901112009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Discontinued - - MYCOPHENOLATE MOFETILTEVA PHARMSANDA 0654912009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Rx AB - MYCOPHENOLATE MOFETILACCORD HLTHCAREANDA 0902532009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Rx AB - MYCOPHENOLATE MOFETILMYLANANDA 0655202009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Discontinued - - MYCOPHENOLATE MOFETILZYDUS PHARMS USA INCANDA 0654332009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Discontinued - - MYCOPHENOLATE MOFETILACCORD HLTHCAREANDA 0654162009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Rx AB - MYCOPHENOLATE MOFETILMYLANANDA 0655212009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued - - MYCOPHENOLATE MOFETILTEVA PHARMSANDA 0654572009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued - - MYCOPHENOLATE MOFETILZYDUS PHARMS USA INCANDA 0654772009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued - - MYCOPHENOLATE MOFETILAPOTEX CORPANDA 0904192009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Discontinued - - MYCOPHENOLATE MOFETILAPOTEXANDA 0904992009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued - - MYCOPHENOLATE MOFETILSANDOZANDA 0653792008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Rx AB - MYCOPHENOLATE MOFETILSANDOZANDA 0654512008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Rx AB - MYCOPHENOLATE MOFETILHIKMAANDA 0654102008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Discontinued - - MYCOPHENOLATE MOFETILHIKMAANDA 0654132008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued -
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 12194143 | in 13 yr | ProductU-1752 | |
| 12097285 | in 13 yr | ProductU-1752 | |
| 12226526 | in 13 yr | ProductU-1752 | |
| 11931455 | in 13 yr | ProductU-1752 | |
| 12097284 | in 13 yr | Product |
Approval history
FDA approval span
First approval
31 yr 11 mo ago
Most recent approval
5 mo ago
Approvals span 1995–2026 across 46 FDA applications.
Brand (NDA) 49%
Generic (ANDA) 4291%
Mycophenolate mofetil: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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