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MYFORTIC

NDA

MYCOPHENOLATE SODIUM | N050791 | NOVARTIS PHARMACEUTICALS CORP

2 strengths0 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

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
NOVARTIS AG et al v. ACCORD HEALTHCARE, INC. USA et al 1:2013cv01013 3 patentsmycophenolate sodium (mycophenolic acid sodium salt)	D.D.C.	2013-07-03	Terminated 2014-01-28	—
NOVARTIS AG et al v. ACCORD HEALTHCARE, INC. USA et al 1:2011cv01631 3 patentsmycophenolate sodium	D.D.C.	2011-09-09	Terminated 2012-12-10	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

462 trials from ClinicalTrials.gov — 15 recruiting, 19 active, 294 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
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
Uterine Transplantation and Pregnancy Induction in Women Affected by Absolute Uterine Infertility NCT02656550	N/A	Active	Baylor Research Institute	38	2015-11-11 → 2026-11
Vorinostat for Graft vs Host Disease Prevention in Children, Adolescents and Young Adults Undergoing Allogeneic Blood and Marrow Transplantation NCT03842696	Phase 1/2	Active	University of Michigan Rogel Cancer Center	43	2020-02-04 → 2026-04-01
Cytokine Induced Memory-like NK Cell Adoptive Therapy After Haploidentical Donor Hematopoietic Cell Transplantation NCT02782546	Phase 2	Active	Washington University School of Medicine	60	2017-01-30 → 2028-02-13

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$14.93

per ea

Lowest NADAC/Unit

$7.43

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00078038666MYFORTIC 360 MG TABLET	$14.93	EA	Brand	$0.2431	2026-07-08
00078038566MYFORTIC 180 MG TABLET	$7.43	EA	Brand	$0.1103	2026-07-08

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$535.28

Highest Price

$1257.92

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00078-0385-66MYFORTIC 180MG DR TAB	$628.97	FSS	Novartis Pharmaceuticals Corporation	08/31/2026
00078-0385-66MYFORTIC 180MG DR TAB	$535.28	Big4	Novartis Pharmaceuticals Corporation	08/31/2026
00078-0386-66MYFORTIC 360MG DR TAB	$1257.92	FSS	Novartis Pharmaceuticals Corporation	08/31/2026
00078-0386-66MYFORTIC 360MG DR TAB	$1078.82	Big4	Novartis Pharmaceuticals Corporation	08/31/2026

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

Medicare Part D Spending

CMS annual spending data for Myfortic (2024)

Total Spending

$1.1M

Total Claims

756

Beneficiaries

182

Avg Cost/Unit

$10.20

Spending Trend

$2.6M(2019)→$2.4M(2020)→$1.8M(2021)→$1.5M(2022)→$1.3M(2023)→$1.1M(2024)

YoY Change:-0.6%

5yr CAGR:+2.6%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

Medicare Part B Spending

CMS physician-administered drug spending for Mycophenolic Acid (2024)

Total Spending

$17.9M

Total Claims

262,752

Beneficiaries

31,025

ASP Price

$0.49

Spending Trend

$140.0M(2019)→$103.2M(2020)→$75.7M(2021)→$49.0M(2022)→$27.7M(2023)→$17.9M(2024)

YoY Change:-34.5%

5yr CAGR:-33.4%

HCPCS: J7518 — Mycophenolic acid, oral, 180 mg

Source: CMS Medicare Part B Spending by Drug (2024). Shows physician-administered drug costs.

API Supply Chain12 active DMFs2 inactive

12 active API suppliers hold Drug Master Files for this ingredient.

CONCORD BIOTECH LTDMYCOPHENOLATE SODIUM USP

DMF 219072008

APOTEX INCMYCOPHENOLATE SODIUM USP

DMF 228192009

BIOCON LTDMYCOPHENOLATE SODIUM

DMF 235192010

TEVA PHARMACEUTICAL INDUSTRIES LTDMYCOPHENOLATE SODIUM

DMF 241292010

FORMOSA LABORATORIES INCMYCOPHENOLATE SODIUM

DMF 243972010

EMCURE PHARMACEUTICALS LTDMYCOPHENOLATE SODIUM USP

DMF 336762019

SOLARA ACTIVE PHARMA SCIENCES LTDMYCOPHENOLATE SODIUM USP

DMF 357222021

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTDMYCOPHENOLATE SODIUM USP

DMF 358482021

CHONGQING DAXIN PHARMACEUTICAL CO LTDMYCOPHENOLATE SODIUM

DMF 378762023

WUXI FORTUNE PHARMACEUTICAL CO LTDMYCOPHENOLATE SODIUM

DMF 399632024

JOYANG LABORATORIESMYCOPHENOLATE SODIUM

DMF 408282024

RAKSHIT PHARMACEUTICALS LTDMYCOPHENOLATE SODIUM

DMF 422562025

EXCELLA GMBHInactiveMYCOPHENOLATE SODIUM

DMF 221562008

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTDInactiveMYCOPHENOLATE SODIUM

DMF 234352010

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

Approval Letters

24 letters from Drugs@FDA

Date	Submission	Document
Jun 30, 2025	SUPPL -40	View Letter (PDF)
Aug 14, 2024	SUPPL -38	View Letter (PDF)
Mar 16, 2022	SUPPL -35	View Letter (PDF)
Aug 13, 2021	SUPPL -36	View Letter (PDF)
Apr 23, 2021	SUPPL -34	View Letter (PDF)
Mar 17, 2021	SUPPL -32	View Letter (PDF)
Jan 19, 2021	SUPPL -33	View Letter (PDF)
Apr 29, 2020	SUPPL -30	View Letter (PDF)
Nov 16, 2015	SUPPL -22	View Letter (PDF)
Oct 29, 2015	SUPPL -24	View Letter (PDF)
Aug 12, 2015	SUPPL -21	View Letter (PDF)
Oct 1, 2013	SUPPL -19	View Letter (PDF)
Oct 1, 2013	SUPPL -18	View Letter (PDF)
May 7, 2013	SUPPL -12	View Letter (PDF)
Sep 27, 2012	SUPPL -5	View Letter (PDF)
Jun 26, 2012	SUPPL -14	View Letter (PDF)
Nov 3, 2010	SUPPL -11	View Letter (PDF)
Nov 9, 2009	SUPPL -8	View Letter (PDF)
Jul 17, 2009	SUPPL -7	View Letter (PDF)
Apr 1, 2009	SUPPL -6	View Letter (PDF)
Dec 19, 2008	SUPPL -4	View Letter (PDF)
May 14, 2008	SUPPL -2	View Letter (PDF)
Nov 8, 2007	SUPPL -1	View Letter (PDF)
Mar 3, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 180MG BASE

RLDAB

0 patents0 exclusivities▴

TABLET, DELAYED RELEASE;ORAL | Approved: Feb 27, 2004

No patent or exclusivity listings for this strength.

#002 — EQ 360MG BASE

RLDAB

0 patents0 exclusivities▾

TABLET, DELAYED RELEASE;ORAL | Approved: Feb 27, 2004