FDA Orange Book · active-ingredient family
Mycophenolate sodium
Mycophenolate sodium: 1 brand, 12 generics; first approved Feb 27, 2004; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 12 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
12
Listed patents
0
Presentations
26
Brand (NDA) products
Originator applications
- MYFORTICRLDNOVARTISNDA 05079120042 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 180MG BASE TABLET, DELAYED RELEASE ORAL Rx AB EQ 360MG BASE TABLET, DELAYED RELEASE ORAL Rx AB
Generic (ANDA) products (12)
Abbreviated applications
- MYCOPHENOLATE SODIUMFOSUN WANBANGANDA 21663720242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 180MG BASE TABLET, DELAYED RELEASE ORAL Rx AB EQ 360MG BASE TABLET, DELAYED RELEASE ORAL Rx AB - MYCOPHENOLATE SODIUMAUROBINDO PHARMA LTDANDA 21860320242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 180MG BASE TABLET, DELAYED RELEASE ORAL Rx AB EQ 360MG BASE TABLET, DELAYED RELEASE ORAL Rx AB - MYCOPHENOLATE SODIUMBIOCON PHARMAANDA 21703120232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 180MG BASE TABLET, DELAYED RELEASE ORAL Rx AB EQ 360MG BASE TABLET, DELAYED RELEASE ORAL Rx AB - MYCOPHENOLATE SODIUMBIOCON PHARMAANDA 21463020212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 180MG BASE TABLET, DELAYED RELEASE ORAL Rx AB EQ 360MG BASE TABLET, DELAYED RELEASE ORAL Rx AB - MYCOPHENOLATE SODIUMTWI PHARMSANDA 21428920212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 180MG BASE TABLET, DELAYED RELEASE ORAL Discontinued — EQ 360MG BASE TABLET, DELAYED RELEASE ORAL Discontinued — - MYCOPHENOLATE SODIUMALKEM LABS LTDANDA 20831520212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 180MG BASE TABLET, DELAYED RELEASE ORAL Rx AB EQ 360MG BASE TABLET, DELAYED RELEASE ORAL Rx AB - MYCOPHENOLATE SODIUMYICHANG HUMANWELLANDA 21437620212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 180MG BASE TABLET, DELAYED RELEASE ORAL Rx AB EQ 360MG BASE TABLET, DELAYED RELEASE ORAL Rx AB - MYCOPHENOLATE SODIUMCONCORD BIOTECH LTDANDA 21117320192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 180MG BASE TABLET, DELAYED RELEASE ORAL Rx AB EQ 360MG BASE TABLET, DELAYED RELEASE ORAL Rx AB - MYCOPHENOLATE SODIUMACCORD HLTHCAREANDA 20255520172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 180MG BASE TABLET, DELAYED RELEASE ORAL Rx AB EQ 360MG BASE TABLET, DELAYED RELEASE ORAL Rx AB - MYCOPHENOLATE SODIUMTEVA PHARMS USAANDA 20272020142 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 180MG BASE TABLET, DELAYED RELEASE ORAL Discontinued — EQ 360MG BASE TABLET, DELAYED RELEASE ORAL Discontinued — - MYCOPHENOLATE SODIUMRK PHARMAANDA 09124820142 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 360MG BASE TABLET, DELAYED RELEASE ORAL Discontinued — EQ 180MG BASE TABLET, DELAYED RELEASE ORAL Discontinued — - MYCOPHENOLATE SODIUMAPOTEX INCANDA 09155820122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 180MG BASE TABLET, DELAYED RELEASE ORAL Rx AB EQ 360MG BASE TABLET, DELAYED RELEASE ORAL Rx AB
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
22 yr 11 mo ago
Most recent approval
2 yr 5 mo ago
Approvals span 2004–2024 across 13 FDA applications.
Brand (NDA) 18%
Generic (ANDA) 1292%
Mycophenolate sodium: 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.
