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CELLCEPT

NDA

MYCOPHENOLATE MOFETIL HYDROCHLORIDE | N050758 | ROCHE PALO ALTO LLC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Hoffmann-LaRoche Inc., and Roche Palo Alto LLC [Arnold & Porter, LLP] - Citiz... FDA-2009-P-0103 · 3 docket documents Hoffmann-LaRoche Inc. and Roche Palo Alto LLC filed this petition requesting that FDA stay approval of Apotex's ANDAs 90-499 and 90-419 for generic mycophenolate mofetil (Cellcept) until the earlier of thirty months from receipt of Paragraph IV certification notice, resolution of their patent infrin	505(q) Stay Request	2009-02-26	Denied	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

407 trials from ClinicalTrials.gov — 15 recruiting, 18 active, 246 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
RCT Comparing Immunosuppressive Regimens in Elderly Renal Transplant Recipients NCT03797196	Phase 4	Active	University Medical Center Groningen	374	2019-07-29 → 2026-12
Clinical Study Evaluating Two Treatment Protocols for Immunosuppressive Drugs. Looking at 3-year Incidence of CLAD.NCT02936505	N/A	Active	Vastra Gotaland Region	249	2016-10-12 → 2026-10-30
Combination Chemotherapy, Total Body Irradiation, and Donor Blood Stem Cell Transplant in Treating Patients With Secondary Myelofibrosis NCT03118492	Phase 1	Active	City of Hope Medical Center	22	2017-05-24 → 2027-04-29
Sorafenib, Busulfan and Fludarabine in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia Undergoing Donor Stem Cell Transplant NCT03247088	Phase 1/2	Active	M.D. Anderson Cancer Center	74	2017-07-30 → 2027-12-31
Total Marrow and Lymphoid Irradiation as Conditioning Regimen Before Hematopoietic Cell Transplantation in Patients With Myelodysplastic Syndrome or Acute Leukemia NCT04262843	Phase 2	Active	City of Hope Medical Center	33	2020-02-07 → 2026-06-23
Busulfan, Fludarabine Phosphate, and Post-Transplant Cyclophosphamide in Treating Patients With Blood Cancer Undergoing Donor Stem Cell Transplant NCT02861417	Phase 2	Active	M.D. Anderson Cancer Center	204	2016-08-05 → 2026-08-31
Optimizing PTCy Dose and Timing NCT03983850	Phase 1/2	Active	National Cancer Institute (NCI)	105	2019-07-09 → 2026-10-26
Tacrolimus/Everolimus vs. Tacrolimus/MMF in Pediatric Heart Transplant Recipients Using the MATE Score NCT03386539	Phase 3	Active	Boston Children's Hospital	211	2018-01-29 → 2024-01
Chemotherapy, Total Body Irradiation, and Post-Transplant Cyclophosphamide in Reducing Rates of Graft Versus Host Disease in Patients With Hematologic Malignancies Undergoing Donor Stem Cell Transplant NCT03192397	Phase 1/2	Active	Roswell Park Cancer Institute	35	2017-08-09 → 2027-05-21
Trial Evaluating MGTA-456 in Patients With High-Risk Malignancy NCT03674411	Phase 2	Active	Masonic Cancer Center, University of Minnesota	22	2019-01-02 → 2026-12-01

Source: ClinicalTrials.gov. Trials matched by ingredient name.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$176.67

Highest Price

$425.40

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00004-0298-09CELLCEPT IV 500MG/20ML INJECTION	$425.40	FSS	Genentech USA, Inc.	09/14/2028
00004-0298-09CELLCEPT IV 500MG/20ML INJECTION	$176.67	Big4	Genentech USA, Inc.	09/14/2028

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain1 active DMF

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTDMYCOPHENOLATE MOFETIL HYDROCHLORIDE ANHYDROUS

DMF 243722010

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

31 letters from Drugs@FDA

Date	Submission	Document
Jun 30, 2025	SUPPL -52	View Letter (PDF)
Aug 14, 2024	SUPPL -51	View Letter (PDF)
Aug 11, 2022	SUPPL -48	View Letter (PDF)
Jun 7, 2022	SUPPL -47	View Letter (PDF)
Jun 7, 2022	SUPPL -49	View Letter (PDF)
Oct 25, 2021	SUPPL -42	View Letter (PDF)
Oct 25, 2021	SUPPL -43	View Letter (PDF)
Aug 12, 2021	SUPPL -45	View Letter (PDF)
Apr 23, 2021	SUPPL -44	View Letter (PDF)
Jan 19, 2021	SUPPL -41	View Letter (PDF)
Dec 17, 2019	SUPPL -37	View Letter (PDF)
Aug 24, 2018	SUPPL -33	View Letter (PDF)
Dec 27, 2017	SUPPL -34	View Letter (PDF)
Nov 19, 2015	SUPPL -31	View Letter (PDF)
Jul 14, 2015	SUPPL -30	View Letter (PDF)
Oct 1, 2013	SUPPL -28	View Letter (PDF)
Oct 1, 2013	SUPPL -29	View Letter (PDF)
Sep 27, 2012	SUPPL -20	View Letter (PDF)
Jun 26, 2012	SUPPL -26	View Letter (PDF)
Jun 12, 2012	SUPPL -24	View Letter (PDF)
Nov 9, 2009	SUPPL -22	View Letter (PDF)
Jun 23, 2009	SUPPL -19	View Letter (PDF)
Mar 5, 2009	SUPPL -18	View Letter (PDF)
Dec 24, 2008	SUPPL -17	View Letter (PDF)
May 15, 2008	SUPPL -16	View Letter (PDF)
Jan 9, 2008	SUPPL -13	View Letter (PDF)
Sep 25, 2007	SUPPL -14	View Letter (PDF)
Oct 19, 2005	SUPPL -12	View Letter (PDF)
Apr 19, 2005	SUPPL -10	View Letter (PDF)
Mar 10, 2003	SUPPL -5	View Letter (PDF)
Jul 28, 2000	SUPPL -4	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 500MG/VIAL

RLDAP

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Aug 12, 1998

No patent or exclusivity listings for this strength.