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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

3 trials from ClinicalTrials.gov — 2 recruiting, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
This Study is a Non-interventional Disease Registry of Adolescent and Adult Patients With Atopic Dermatitis Who Initiate or Switch Any Systemic Treatment NCT07290803	—	Recruiting	Sanofi	1,000	2025-11-17 → 2034-01-30
211^At-BC8-B10 Before Donor Stem Cell Transplant in Treating Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome, or Mixed-Phenotype Acute Leukemia NCT03128034	Phase 1/2	Recruiting	Fred Hutchinson Cancer Center	75	2017-10-24 → 2029-03-31
Evaluating the Safety of Myfortic (Mycophenolate Sodium) in Patients With Lupus Nephritis NCT04645589	—	Completed	Novartis Pharmaceuticals	69	2021-03-16 → 2025-08-13

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

Medicare Part D Spending

CMS annual spending data for Myfortic (2023)

Total Spending

$1.3M

Total Claims

958

Beneficiaries

215

Avg Cost/Unit

$10.27

Spending Trend

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

YoY Change:+17.1%

5yr CAGR:+4.3%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

Medicare Part B Spending

CMS physician-administered drug spending for Mycophenolic Acid (2023)

Total Spending

$27.7M

Total Claims

262,449

Beneficiaries

31,256

ASP Price

—

HCPCS: J7518 — Mycophenolic acid, oral, 180 mg

Source: CMS Medicare Part B Spending by Drug (2023). 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