Mycophenolate Mofetil

Prevents organ rejection. Sold as Cellcept, Myhibbin. Every FDA application for this active ingredient: 4 branded and 42 generic.

As of Nov 14, 2026, FDA lists 46 applications for Mycophenolate Mofetil (sold as Cellcept, Myhibbin), first approved May 3, 1995, with 13 new uses approved and 1 published complete response letter.

First approved: May 3, 1995
Applications: 46
New uses approved: 13
Complete response letters: 1
Medicare spending, 2025: $79.6M
First approved in the EU: Feb 14, 1996

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Mycophenolate Mofetil	Part D	$68.0M	+7%	124,279
CELlcept (J7517)	Part B	$7.7M	-16%	41,260
Cellcept	Part D	$3.9M	-5%	321
Myhibbin	Part D	$107K	+742%	32
CELlcept (J7519)	Part B	$0K	-100%	0
MYCOPHENOLATE MOFETIL	Part B	$0K	New	0

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

CELLCEPT 200 MG/ML ORAL SUSP: $8.31 per MLBrand · 0% in a year
CELLCEPT 250 MG CAPSULE: $8.64 per unitBrand · 0% in a year
CELLCEPT 500 MG TABLET: $17.36 per unitBrand · +0% in a year

Orphan Designations (FDA)

2 designations, 0 approved for the designated use; see all orphan designations

Treatment of pemphigus vulgarisHoffman-La Roche, Inc. · designated May 26, 2006
Treatment of myasthenia gravisHoffman-LaRoche, Inc. · designated Dec 19, 2005

Approvals in the EU (EMA)

First approved in the EU 9 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Myclausen, genericPassauer Pharma GmbH · Oct 7, 2010
Mycophenolate mofetil Teva, genericTeva Pharma B.V. · Feb 21, 2008
Myfenax, genericTeva B.V. · Feb 21, 2008
CellCept, new substanceRoche Registration GmbH · Feb 14, 1996

Approvals in Japan (PMDA)

PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

CellceptDrugs with a new indication and a new dosage for the treatment of refractory nephrotic syndrome (for use frequent relapsing or steroid-dependent nephrotic… · [1] [2] Chugai Pharmaceutical Co., Ltd., [3] Viatris Healthcare G.K. · Sep 19, 2025
CellceptDrugs with a new indication and a new dosage for the treatment of systemic sclerosis-associated interstitial lung disease. · Chugai Pharmaceutical Co., Ltd. · Jun 24, 2024
CellceptDrugs with a new indication and a new dosage for the suppression of graft-versus-host disease in hematopoietic stem cell transplantation. · (1) (2) Chugai Pharmaceutical Co., Ltd. (3) Mylan Seiyaku Ltd. · Jun 25, 2021
CellceptDrugs with a new additional indication and a new dosage for the treatment of lupus nephritis. · Mylan Seiyaku Ltd. · May 13, 2016
CellceptA drug with a new additional pediatric dosage indicated for the prevention of rejection in renal transplantation. · Chugai Pharmaceutical Co., Ltd. · Sep 16, 2011

Clinical Trials

210 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Lanoracopan to Prevent Acute GVHD Following Haploidentical Peripheral Blood Stem Cell Transplantation: A Prospective Multicenter Single-Arm Exploratory StudyHematologic Malignancies, Haploidentical Peripheral Blood Stem Cell Transplantation · The First Affiliated Hospital of Soochow University	Phase 2	Not yet recruiting	Nov 9, 2026
Busulfan-Based Versus TBI-Based Conditioning for Adult ALL-CR2 Allo-HSCTAcute Lymphoblastic Leukemia, Hematopoietic Stem Cell Transplantation · Peking University People's Hospital	Not applicable	Not yet recruiting	Nov 5, 2026
Safety and Efficacy of Secukinumab Versus Mycophenolate Mofetil in Relapsing Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (SMART)Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD) · Chinese PLA General Hospital	Phase 3	Not yet recruiting	Nov 4, 2026
Study of Allogeneic Stem Cell Transplant in Myelodysplastic Syndrome Following Conditioning With Fludarabine and Total Body Irradiation 800 cGyMDS, Myelodysplastic Syndrome MDS · Ronald Paquette	Phase 2	Not yet recruiting	Oct 27, 2026
Microbiota Changes Related to Outcomes in Kidney TransplantationEnd-stage Renal Disease (ESRD), Kidney Transplantation · Hospices Civils de Lyon	—	Not yet recruiting	Oct 26, 2026
Clinical Efficacy of Telitacicept in Sjögren's Disease With Interstitial Lung DiseaseSjögren's Disease, Interstitial Lung Disease · Peking University People's Hospital	—	Recruiting	Sep 28, 2026
The Primary Objective of the Trial is to Evaluate the Effect of the Addition of Belantamab Mafodotin to Standard of Care Therapy on the Titres of Serum Anti-dsDNA Antibodies in Patients With Previously Treated SLE.SLE - Systemic Lupus Erythematosus · Medical Association for the Study of Cancer Biology and Treatment	Phase 2	Not yet recruiting	Sep 28, 2026
CSF-1R Inhibitor, Axatilimab, for Prevention of Acute and Chronic GVHD After HLA-Matched Related and Unrelated Donor Allogeneic Stem Cell TransplantationGraft -Versus-host-disease · Medical College of Wisconsin	Phase 2	Not yet recruiting	Sep 8, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


May 3, 1995	CellceptNDA 50722 · New molecular entity	Roche Palo	43	Marketed
Jun 19, 1997	CellceptNDA 50723 · New dosage form	Roche Palo	42	Marketed
Oct 1, 1998	CellceptNDA 50759 · New dosage form	Roche Palo	45	Marketed
Jul 29, 2008	Mycophenolate MofetilANDA 65410	Hikma	20	Discontinued
Jul 29, 2008	Mycophenolate MofetilANDA 65413	Hikma	20	Discontinued
Oct 15, 2008	Mycophenolate MofetilANDA 65451	Sandoz	18	Marketed
Oct 15, 2008	Mycophenolate MofetilANDA 65379	Sandoz	18	Marketed
Apr 22, 2009	Mycophenolate MofetilANDA 90499	Apotex	8	Discontinued
Apr 22, 2009	Mycophenolate MofetilANDA 90419	Apotex Corp	8	Discontinued
May 4, 2009	Mycophenolate MofetilANDA 65416	Accord Hlthcare	17	Marketed
May 4, 2009	Mycophenolate MofetilANDA 65433	Zydus Pharms USA Inc	0	Discontinued
May 4, 2009	Mycophenolate MofetilANDA 65457	Teva Pharms	12	Discontinued
May 4, 2009	Mycophenolate MofetilANDA 65477	Zydus Pharms USA Inc	0	Discontinued
May 4, 2009	Mycophenolate MofetilANDA 90253	Accord Hlthcare	17	Marketed
May 4, 2009	Mycophenolate MofetilANDA 65521	Mylan	17	Discontinued
May 4, 2009	Mycophenolate MofetilANDA 65520	Mylan	17	Discontinued
May 6, 2009	Mycophenolate MofetilANDA 65491	Teva Pharms	15	Marketed
Dec 22, 2009	Mycophenolate MofetilANDA 90111	Strides Pharma Intl	12	Discontinued
Jun 10, 2010	Mycophenolate MofetilANDA 90456	Strides Pharma	16	Marketed
Jun 10, 2010	Mycophenolate MofetilANDA 90055	Strides Pharma	16	Marketed
Jul 16, 2010	Mycophenolate MofetilANDA 90606	Amneal	10	Discontinued
Sep 13, 2010	Mycophenolate MofetilANDA 90464	Dr Reddys Labs Ltd	0	Discontinued
Oct 27, 2011	Mycophenolate MofetilANDA 91315	Dr Reddys Labs Ltd	0	Discontinued
Nov 4, 2011	Mycophenolate MofetilANDA 91249	Alkem Labs Ltd	17	Marketed
Jun 13, 2013	Mycophenolate MofetilANDA 200197	Alkem Labs Ltd	15	Marketed
Nov 14, 2014	Mycophenolate MofetilANDA 203005	Alkem Labs Ltd	13	Marketed
Dec 15, 2014	Mycophenolate MofetilANDA 90661	Jubilant Cadista	7	Discontinued
Dec 15, 2014	Mycophenolate MofetilANDA 90762	Jubilant Cadista	7	Discontinued
Nov 13, 2017	Mycophenolate MofetilANDA 204077	Zhejiang Hisun Pharm	8	Marketed
Nov 16, 2017	Mycophenolate MofetilANDA 204076	Zhejiang Hisun Pharm	7	Marketed
Jan 8, 2019	Mycophenolate MofetilANDA 210181	Concord Biotech Ltd	8	Marketed
Feb 12, 2019	Mycophenolate MofetilANDA 210370	Vistapharm LLC	9	Marketed
Jul 31, 2020	Mycophenolate MofetilANDA 212087	Concord Biotech Ltd	7	Marketed
Jul 29, 2021	Mycophenolate MofetilANDA 214525	Quagen	6	Marketed
Nov 2, 2021	Mycophenolate MofetilANDA 214871	Amneal	5	Marketed
Jan 25, 2022	Mycophenolate MofetilANDA 211272	Teva Pharms USA	3	Discontinued
Aug 29, 2023	Mycophenolate MofetilANDA 212634	Strides Pharma Intl	4	Marketed
Sep 11, 2023	Mycophenolate MofetilANDA 213955	Rising	2	Marketed
Jan 5, 2024	Mycophenolate MofetilANDA 217828	Aurobindo Pharma Ltd	3	Marketed
Feb 20, 2024	Mycophenolate MofetilANDA 217937	Aurobindo Pharma	3	Marketed
May 1, 2024	MyhibbinNDA 216482 · New formulation or manufacturer	Azurity	4	Marketed
Sep 26, 2024	Mycophenolate MofetilANDA 218227	Aurobindo Pharma Ltd	2	Marketed
Oct 22, 2024	Mycophenolate MofetilANDA 207022	Hetero Labs Ltd V	1	Marketed
Oct 22, 2024	Mycophenolate MofetilANDA 208119	Hetero Labs Ltd V	2	Marketed
Nov 7, 2024	Mycophenolate MofetilANDA 214079	Wuxi	1	Marketed
Jun 1, 2026	Mycophenolate MofetilANDA 218566	Neocubes Pharma	1	Marketed

Complete Response Letters

FDA's published letters for these applications

Letter	Product	Now
Jan 6, 2023	Mycophenolate mofetilRisk Evaluation And Mitigation Strategy Requirements, Submission Of Rems Document In Spl Format	Approved

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA