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 Aug 16, 2039

Brands (NDA)

4

Generics (ANDA)

42

Listed patents

5

Next patent expiry

Aug 16, 2039

in 13 yr 3 mo

Originator applications

Brand (NDA) products

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

Abbreviated applications

Generic (ANDA) products (42)

MYCOPHENOLATE MOFETIL

CONCORD BIOTECH LTDANDA 2185662026

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG/ML	FOR SUSPENSION	ORAL	Rx	AB

MYCOPHENOLATE MOFETIL

WUXIANDA 2140792024

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	CAPSULE	ORAL	Rx	AB

MYCOPHENOLATE MOFETIL

HETERO LABS LTD VANDA 2070222024

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	CAPSULE	ORAL	Rx	AB

MYCOPHENOLATE MOFETIL

HETERO LABS LTD VANDA 2081192024

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG	TABLET	ORAL	Rx	AB

MYCOPHENOLATE MOFETIL

AUROBINDO PHARMA LTDANDA 2182272024

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG/ML	FOR SUSPENSION	ORAL	Rx	AB

MYCOPHENOLATE MOFETIL

AUROBINDO PHARMAANDA 2179372024

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG	TABLET	ORAL	Rx	AB

MYCOPHENOLATE MOFETIL

AUROBINDO PHARMA LTDANDA 2178282024

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	CAPSULE	ORAL	Rx	AB

MYCOPHENOLATE MOFETIL

RISINGANDA 2139552023

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG/ML	FOR SUSPENSION	ORAL	Rx	AB

MYCOPHENOLATE MOFETIL

STRIDES PHARMA INTLANDA 2126342023

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG/ML	FOR SUSPENSION	ORAL	Rx	AB

MYCOPHENOLATE MOFETIL

TEVA PHARMS USAANDA 2112722022

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG/ML	FOR SUSPENSION	ORAL	Discontinued	—

MYCOPHENOLATE MOFETIL

AMNEALANDA 2148712021

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG/ML	FOR SUSPENSION	ORAL	Rx	AB

MYCOPHENOLATE MOFETIL

LANNETT CO INCANDA 2145252021

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG/ML	FOR SUSPENSION	ORAL	Rx	AB

MYCOPHENOLATE MOFETIL

CONCORD BIOTECH LTDANDA 2120872020

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG	TABLET	ORAL	Rx	AB

MYCOPHENOLATE MOFETIL

VISTAPHARM LLCANDA 2103702019

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG/ML	FOR SUSPENSION	ORAL	Rx	AB

MYCOPHENOLATE MOFETIL

CONCORD BIOTECH LTDANDA 2101812019

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	CAPSULE	ORAL	Rx	AB

MYCOPHENOLATE MOFETIL

ZHEJIANG HISUN PHARMANDA 2040762017

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG	TABLET	ORAL	Rx	AB

MYCOPHENOLATE MOFETIL

ZHEJIANG HISUN PHARMANDA 2040772017

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	CAPSULE	ORAL	Rx	AB

MYCOPHENOLATE MOFETIL

JUBILANT CADISTAANDA 0907622014

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	CAPSULE	ORAL	Discontinued	—

MYCOPHENOLATE MOFETIL

JUBILANT CADISTAANDA 0906612014

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG	TABLET	ORAL	Discontinued	—

MYCOPHENOLATE MOFETIL

ALKEM LABS LTDANDA 2030052014

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG/ML	FOR SUSPENSION	ORAL	Rx	AB

MYCOPHENOLATE MOFETIL

ALKEM LABS LTDANDA 2001972013

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	CAPSULE	ORAL	Rx	AB

MYCOPHENOLATE MOFETIL

ALKEM LABS LTDANDA 0912492011

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG	TABLET	ORAL	Rx	AB

MYCOPHENOLATE MOFETIL

DR REDDYS LABS LTDANDA 0913152011

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	CAPSULE	ORAL	Discontinued	—

MYCOPHENOLATE MOFETIL

DR REDDYS LABS LTDANDA 0904642010

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG	TABLET	ORAL	Discontinued	—

MYCOPHENOLATE MOFETIL

AMNEALANDA 0906062010

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG	TABLET	ORAL	Discontinued	—

MYCOPHENOLATE MOFETIL

STRIDES PHARMAANDA 0900552010

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	CAPSULE	ORAL	Rx	AB

MYCOPHENOLATE MOFETIL

STRIDES PHARMAANDA 0904562010

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG	TABLET	ORAL	Rx	AB

MYCOPHENOLATE MOFETIL

STRIDES PHARMA INTLANDA 0901112009

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	CAPSULE	ORAL	Discontinued	—

MYCOPHENOLATE MOFETIL

TEVA PHARMSANDA 0654912009

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	CAPSULE	ORAL	Rx	AB

MYCOPHENOLATE MOFETIL

ACCORD HLTHCAREANDA 0902532009

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	CAPSULE	ORAL	Rx	AB

MYCOPHENOLATE MOFETIL

MYLANANDA 0655202009

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	CAPSULE	ORAL	Discontinued	—

MYCOPHENOLATE MOFETIL

ZYDUS PHARMS USA INCANDA 0654332009

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	CAPSULE	ORAL	Discontinued	—

MYCOPHENOLATE MOFETIL

ACCORD HLTHCAREANDA 0654162009

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG	TABLET	ORAL	Rx	AB

MYCOPHENOLATE MOFETIL

MYLANANDA 0655212009

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG	TABLET	ORAL	Rx	AB

MYCOPHENOLATE MOFETIL

TEVA PHARMSANDA 0654572009

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG	TABLET	ORAL	Discontinued	—

MYCOPHENOLATE MOFETIL

ZYDUS PHARMS USA INCANDA 0654772009

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG	TABLET	ORAL	Discontinued	—

MYCOPHENOLATE MOFETIL

APOTEX CORPANDA 0904192009

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	CAPSULE	ORAL	Discontinued	—

MYCOPHENOLATE MOFETIL

APOTEXANDA 0904992009

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG	TABLET	ORAL	Discontinued	—

MYCOPHENOLATE MOFETIL

SANDOZANDA 0653792008

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	CAPSULE	ORAL	Rx	AB

MYCOPHENOLATE MOFETIL

SANDOZANDA 0654512008

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG	TABLET	ORAL	Rx	AB

MYCOPHENOLATE MOFETIL

HIKMAANDA 0654102008

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	CAPSULE	ORAL	Rx	AB

MYCOPHENOLATE MOFETIL

HIKMAANDA 0654132008

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG	TABLET	ORAL	Rx	AB

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Orange Book patent file

Listed patents

Listed patents (5)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
12194143	Aug 16, 2039	in 13 yr 3 mo	ProductU-1752
12097285	Aug 16, 2039	in 13 yr 3 mo	ProductU-1752
12226526	Aug 16, 2039	in 13 yr 3 mo	ProductU-1752
11931455	Aug 16, 2039	in 13 yr 3 mo	ProductU-1752
12097284	Aug 16, 2039	in 13 yr 3 mo	Product

FDA approval span

Approval history

First approval

May 03, 1995

31 yr 8 mo ago

Most recent approval

Jun 01, 2026

1 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.

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