Mycophenolate mofetil - Generic Drug Details

What are the generic drug sources for mycophenolate mofetil and what is the scope of freedom to operate?

Mycophenolate mofetil is the generic ingredient in four branded drugs marketed by Roche Palo, Accord Hlthcare, Alkem Labs Ltd, Apotex Corp, Aurobindo Pharma Ltd, Concord Biotech Ltd, Dr Reddys Labs Ltd, Hetero Labs Ltd V, Hikma, Jubilant Cadista, Mylan, Sandoz, Strides Pharma, Strides Pharma Intl, Teva Pharms, Wuxi, Zhejiang Hisun Pharm, Zydus Pharms Usa Inc, Amneal, Lannett Co Inc, Rising, Teva Pharms Usa, Vistapharm Llc, Azurity, Apotex, Aurobindo Pharma, Bpi Labs, Meitheal, Mylan Labs Ltd, Onesource Specialty, Ph Health, and Zydus Pharms, and is included in fifty-four NDAs. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Mycophenolate mofetil has four patent family members in three countries.

There are twenty-nine drug master file entries for mycophenolate mofetil. Thirty-one suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for mycophenolate mofetil

International Patents:	4
US Patents:	5
Tradenames:	4
Applicants:	32
NDAs:	54
Drug Master File Entries:	29
Finished Product Suppliers / Packagers:	31
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1,005
Patent Applications:	5,629
Drug Prices:	Drug price trends for mycophenolate mofetil
What excipients (inactive ingredients) are in mycophenolate mofetil?	mycophenolate mofetil excipients list
DailyMed Link:	mycophenolate mofetil at DailyMed

See drug prices for mycophenolate mofetil

Recent Clinical Trials for mycophenolate mofetil

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
National Cancer Institute (NCI)	PHASE1
City of Hope Medical Center	PHASE1
Marissa Lobl	EARLY_PHASE1

See all mycophenolate mofetil clinical trials

Generic filers with tentative approvals for MYCOPHENOLATE MOFETIL

Applicant	Application No.	Strength	Dosage Form
		500MG	INJECTABLE; INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for mycophenolate mofetil

Drug Class

Antimetabolite Immunosuppressant

Paragraph IV (Patent) Challenges for MYCOPHENOLATE MOFETIL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CELLCEPT	For Oral Suspension	mycophenolate mofetil	200 mg/mL	050759	1	2011-03-25

US Patents and Regulatory Information for mycophenolate mofetil

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bpi Labs	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	mycophenolate mofetil hydrochloride	INJECTABLE;INJECTION	214283-001	Jun 1, 2023	AP	RX	No	No
Azurity	MYHIBBIN	mycophenolate mofetil	SUSPENSION;ORAL	216482-001	May 1, 2024		RX	Yes	Yes			Y
Dr Reddys Labs Ltd	MYCOPHENOLATE MOFETIL	mycophenolate mofetil	CAPSULE;ORAL	091315-001	Oct 27, 2011		DISCN	No	No
Onesource Specialty	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	mycophenolate mofetil hydrochloride	INJECTABLE;INJECTION	216390-001	Dec 23, 2022	AP	RX	No	No
Alkem Labs Ltd	MYCOPHENOLATE MOFETIL	mycophenolate mofetil	FOR SUSPENSION;ORAL	203005-001	Nov 14, 2014	AB	RX	No	No

Expired US Patents for mycophenolate mofetil

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Roche Palo	CELLCEPT	mycophenolate mofetil	CAPSULE;ORAL	050722-001	May 3, 1995
Roche Palo	CELLCEPT	mycophenolate mofetil	FOR SUSPENSION;ORAL	050759-001	Oct 1, 1998
Roche Palo	CELLCEPT	mycophenolate mofetil	FOR SUSPENSION;ORAL	050759-001	Oct 1, 1998
Roche Palo	CELLCEPT	mycophenolate mofetil	TABLET;ORAL	050723-001	Jun 19, 1997

EU/EMA Drug Approvals for mycophenolate mofetil

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Passauer Pharma GmbH	Myclausen	mycophenolate mofetil	EMEA/H/C/001218Myclausen is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.,	Authorised	yes	no	no	2010-10-07
Roche Registration GmbH	CellCept	mycophenolate mofetil	EMEA/H/C/000082CellCept is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.	Authorised	no	no	no	1996-02-14
Teva B.V.	Myfenax	mycophenolate mofetil	EMEA/H/C/000884Myfenax is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.	Authorised	yes	no	no	2008-02-21
Teva Pharma B.V.	Mycophenolate mofetil Teva	mycophenolate mofetil	EMEA/H/C/000882Mycophenolate mofetil Teva is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.	Authorised	yes	no	no	2008-02-21

International Patents for mycophenolate mofetil

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3836898	SUSPENSION PHARMACEUTIQUE POUR FORME GALÉNIQUE ORALE (PHARMACEUTICAL SUSPENSION FOR ORAL DOSAGE)
European Patent Office	3836898	SUSPENSION PHARMACEUTIQUE POUR FORME GALÉNIQUE ORALE (PHARMACEUTICAL SUSPENSION FOR ORAL DOSAGE)
World Intellectual Property Organization (WIPO)	2020039263
United Kingdom	202103764
United Kingdom	2591396	Pharmaceutical suspension for oral dosage

Supplementary Protection Certificates for mycophenolate mofetil

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0281713	SPC/GB96/026	United Kingdom		PRODUCT NAME: MYCOPHENOLATE MOFETIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: CH 53337 19951103; CH 53338 19951103; UK EU/1/96/005/001 19960214; UK EU/96/005/002 19960214
0281713	96C0031	Belgium		PRODUCT NAME: MYCOPHENOLATE MOFETIL; NAT. REGISTRATION NO/DATE: EU/1/96/005/001 19960214; FIRST REGISTRATION: CH 53337 19951103

Market Dynamics and Financial Trajectory for Mycophenolate Mofetil

Last updated: December 31, 2025

Executive Summary

Mycophenolate mofetil (MMF) is an immunosuppressant primarily used in organ transplantation and autoimmune disorders. The drug's global market is driven by rising transplantation procedures, increased prevalence of autoimmune diseases, and advancements in immunosuppressive therapies. The compound’s patent landscape, competitive positioning, and regulatory environment significantly influence its commercial trajectory. This report provides a comprehensive analysis of MMF’s current market dynamics, including market size, key players, regulatory landscape, and growth forecasts, supported by data and strategic insights.

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What Is Mycophenolate Mofetil and How Does It Work?

Mycophenolate mofetil is a prodrug of mycophenolic acid, which inhibits inosine monophosphate dehydrogenase (IMPDH). This enzyme is vital for purine synthesis in lymphocytes, making MMF effective in suppressing T and B lymphocyte proliferation.

Key Specifications:

Characteristic	Details
Chemical Class	furan derivative, immunosuppressant
Mode of Action	IMPDH inhibition leading to lymphocyte suppression
Common Dosage Forms	Oral capsules, intravenous formulations
Typical Indications	Kidney, liver, heart transplantation; autoimmune diseases (e.g., lupus nephritis)
Approval Date	Initially approved in the U.S. in 1995 (Roche's CellCept)

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What Are the Market Drivers and Restraints for MMF?

Market Drivers

Driver	Impact & Rationale	Source / Data Reference
Growing Organ Transplantation Procedures	Increased global transplant rates (e.g., 34,000 kidney transplants in the US in 2021)	[1] National Kidney Foundation
Rising Incidence of Autoimmune Diseases	Lupus, rheumatoid arthritis, and IBD prevalence increasing globally	[2] WHO Epidemiological Data
Strengthening Regulatory Approvals	Expanded indications and new formulations enhancing accessibility	FDA and EMA approvals (2020-2022)
Development of Combination Therapies	Combination with other immunosuppressants improves efficacy	Clinical trial data, 2020-2023

Market Restraints

Restraint	Impact & Mitigation	Source / Data Reference
Patent Expirations	Release of generics reduces market share and prices	Patent expiry timeline (e.g., 2018-2020)
Side Effects and Toxicity	Adverse effects limit patient compliance	Post-market surveillance data
Pricing and Reimbursement Challenges	Cost constraints in healthcare systems	Healthcare policy reports (e.g., US, EU)

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What Is the Current Market Size and Revenue Outlook for MMF?

Global Market Size (2022-2023)

Region	Estimated Market Value (USD, Millions)	CAGR (2023-2027)	Key Notes
North America	$1,200	4.5%	Major market, high transplant volume
Europe	$850	4.2%	Extensive autoimmune disease management
Asia-Pacific	$650	6.0%	Rapid healthcare infrastructure growth
Rest of the World	$250	5.0%	Emerging markets investment
Total	$2,950	4.7% (2023-2027)

Revenue Forecast (2023-2027)

Year	Projected Global Revenue (USD, Millions)	Key Growth Drivers
2023	$3,000	Post-pandemic recovery, expanding approvals
2024	$3,150	Increased transplantation, autoimmunity cases
2025	$3,330	Introducing novel formulations, biosimilars
2026	$3,520	Market consolidation, strategic partnerships
2027	$3,720	Further patent expirations, uptake of generics

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Who Are the Leading Pharmaceutical Players and Competitors?

Company	Market Share (Estimated)	Key Products and Initiatives	Notable Patents & Approvals
F Hoffmann-La Roche (CellCept)	~60% (pre-generic era)	CellCept, Myfortic (delayed-release formulation)	Patent expired 2018 (US)
Novartis	~15%	Mycocumate (generic), biosimilars development	Biosimilar pipeline
Teva Pharmaceuticals	~10%	Generic MMF formulations	Pending biosimilar approvals
Pfizer, Sandoz	Remaining	Generic manufacturing and regional distribution	Diversified portfolio

Patent and Regulatory Landscape

• Patent Expirations: Major patents of Roche's CellCept expired in 2018-2020 [3], opening the market for generics and biosimilars, leading to price erosion.
• Regulatory Approvals: Several biosimilars received approval in the EU and US (e.g., Mircera in EU, 2022), influencing market competitiveness.
• Market Access: Reimbursement policies in developed nations favor broad access, while challenges persist in emerging markets.

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How Do Regulatory Policies Impact MMF Market Trajectory?

Key Regional Policies

Region	Policies & Regulations	Impact on MMF Market
United States	FDA approval pathways for biosimilars (2015+)	Accelerated access, generic entry increases
European Union	EMA biosimilar guidelines (2014+)	Supports biosimilar market penetration
Asia-Pacific	Variable patent enforcement, evolving regulations	Slow, variable uptake of biosimilars
Latin America	Reimbursement and pricing reforms	Restricted access, price sensitivity

Regulatory Challenges

• Biosimilar Interchangeability: Achieving interchangeability designation impacts market uptake.
• Pricing Controls: Stringent pricing regulations may influence margins and investment.
• Post-Market Surveillance: Ongoing safety monitoring affects lifecycle management.

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What Are Key Market Trend Comparisons and Strategic Opportunities?

Aspect	Traditional MMF (CellCept)	Biosimilar/Generic Entry	Emerging Opportunities
Patent Status	Expired (2018-2020)	Present in various regions	Market erosion with generic penetration
Cost Structure	High, branded product	Lower, price-competitive	Capturing cost-sensitive segments
Formulation Innovation	IR formulations (delayed-release)	Standard formulations	Novel delivery, combination therapies
Regulatory Focus	Established protocols	Biosimilar approval pathways	Fast-track approvals, regional expansions

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What Are the Future Growth Opportunities and Risks?

Opportunities

• Biosimilars and Generics: Significant volume expansion post-patent expiry.
• New Indications: Expansion into autoimmune conditions like multiple sclerosis.
• Regional Market Expansion: Increasing penetration in Asia-Pacific and Latin America.
• Combination Regimens: Integration with biologics and targeted therapies for enhanced efficacy.

Risks

• Market Saturation: Growing generic competition suppresses margins.
• Regulatory Hurdles: Stringent approval pathways can delay entry.
• Safety Profiles: Adverse effects may result in restricted usage.
• Pricing Pressures: Healthcare cost containment measures impact profitability.

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Key Takeaways

1. Market Expansion Post-Patent: The expiration of major patents in recent years has catalyzed a shift towards biosimilars and generics, potentially reducing prices but expanding access.
2. Growing Transplant and Autoimmune Indications: An increasing global burden of autoimmune diseases and organ failure sustains demand for MMF.
3. Geographic Diversification: Rapid growth in Asia-Pacific offers diversified revenue streams amid rising healthcare infrastructure.
4. Regulatory Environment: Supportive policies for biosimilars, coupled with challenges like safety monitoring, influence market access.
5. Strategic Focus: Companies investing in formulations, combination therapies, and regional markets can capitalize on emerging growth opportunities.

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FAQs

1. What factors primarily influence the pricing of mycophenolate mofetil?

Pricing is influenced by patent status, competition from biosimilars/generics, regional healthcare policies, and manufacturing costs. Post-patent expiration leads to downward pricing pressure, especially where reimbursement policies favor cost-effective options.

2. How significant is the role of biosimilars in the future of MMF markets?

Biosimilars are poised to play a pivotal role, especially in regions where cost containment is critical. They could capture up to 50% of the MMF market share within five years of approval, driving volume growth but reducing revenues for originator brands.

3. Which regions are expected to experience the highest growth for MMF?

Asia-Pacific is expected to exhibit the highest CAGR (~6%) due to expanding healthcare access, increasing transplant rates, and regulatory reforms favoring biosimilar adoption.

4. What are the main safety concerns associated with MMF therapy?

Potential adverse effects include gastrointestinal issues, hematological abnormalities, increased infection risk, and teratogenicity. Monitoring and patient selection are essential to mitigate these risks.

5. What strategic moves should pharmaceutical companies consider regarding MMF?

Expanding biosimilar portfolios, investing in innovative formulations, exploring new indications, and strengthening regional registration and reimbursement pathways are recommended strategies.

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References

[1] National Kidney Foundation. Kidney Transplant Data 2021.
[2] World Health Organization. Autoimmune Disease Epidemiology, 2022.
[3] PatentScope. Official Patent Expiry Records, 2020.

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This comprehensive analysis aims to equip pharmaceutical stakeholders and investors with decisive intelligence on the evolving landscape of mycophenolate mofetil, facilitating informed strategic planning.