MYCOPHENOLATE MOFETIL HYDROCHLORIDE - Generic Drug Details

What are the generic sources for mycophenolate mofetil hydrochloride and what is the scope of patent protection?

Mycophenolate mofetil hydrochloride is the generic ingredient in two branded drugs marketed by Roche Palo, Amneal, Bpi Labs, Meitheal, Mylan Labs Ltd, Onesource Specialty, Ph Health, Rising, and Zydus Pharms, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for mycophenolate mofetil hydrochloride. Seven suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for MYCOPHENOLATE MOFETIL HYDROCHLORIDE

US Patents:	0
Tradenames:	2
Applicants:	9
NDAs:	9
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	27
Clinical Trials:	1,003
Patent Applications:	276
What excipients (inactive ingredients) are in MYCOPHENOLATE MOFETIL HYDROCHLORIDE?	MYCOPHENOLATE MOFETIL HYDROCHLORIDE excipients list
DailyMed Link:	MYCOPHENOLATE MOFETIL HYDROCHLORIDE at DailyMed

Recent Clinical Trials for MYCOPHENOLATE MOFETIL HYDROCHLORIDE

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

Sponsor	Phase
City of Hope Medical Center	PHASE1
National Cancer Institute (NCI)	PHASE1
Assistance Publique - Hpitaux de Paris	PHASE2

See all MYCOPHENOLATE MOFETIL HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for MYCOPHENOLATE MOFETIL HYDROCHLORIDE

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 HYDROCHLORIDE

Drug Class

Antimetabolite Immunosuppressant

US Patents and Regulatory Information for MYCOPHENOLATE MOFETIL HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ph Health	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	mycophenolate mofetil hydrochloride	INJECTABLE;INJECTION	203575-001	Oct 28, 2016	AP	RX	No	No
Roche Palo	CELLCEPT	mycophenolate mofetil hydrochloride	INJECTABLE;INJECTION	050758-001	Aug 12, 1998	AP	RX	Yes	Yes
Mylan Labs Ltd	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	mycophenolate mofetil hydrochloride	INJECTABLE;INJECTION	203859-001	Mar 31, 2017	AP	RX	No	No
Rising	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	mycophenolate mofetil hydrochloride	INJECTABLE;INJECTION	204043-001	Feb 28, 2017	AP	RX	No	No
Onesource Specialty	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	mycophenolate mofetil hydrochloride	INJECTABLE;INJECTION	216390-001	Dec 23, 2022	AP	RX	No	No
Amneal	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	mycophenolate mofetil hydrochloride	INJECTABLE;INJECTION	211374-001	Mar 5, 2021		DISCN	No	No
Meitheal	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	mycophenolate mofetil hydrochloride	INJECTABLE;INJECTION	212130-001	Jan 15, 2021	AP	RX	No	No

Expired US Patents for MYCOPHENOLATE MOFETIL HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Roche Palo	CELLCEPT	mycophenolate mofetil hydrochloride	INJECTABLE;INJECTION	050758-001	Aug 12, 1998
Roche Palo	CELLCEPT	mycophenolate mofetil hydrochloride	INJECTABLE;INJECTION	050758-001	Aug 12, 1998

Market Dynamics and Financial Trajectory for Mycophenolate Mofetil Hydrochloride

Last updated: January 27, 2026

Executive Summary

Mycophenolate mofetil hydrochloride (Product Name: CellCept) is an immunosuppressive agent primarily used to prevent organ rejection in transplant recipients and treat autoimmune diseases. As regulatory approvals expand and clinical indications grow, the global market is expected to demonstrate sustained growth. Key drivers include rising prevalence of organ transplants, increasing autoimmune disorder incidence, and advancements in immunosuppressive therapies. The evolving competitive landscape, patent expirations, and manufacturing improvements will influence future financial trajectories. This report provides a comprehensive analysis of current market dynamics, forecasted trends, and investment opportunities, with insights geared towards stakeholders, investors, and pharmaceutical companies.

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1. What are the core market drivers for Mycophenolate Mofetil Hydrochloride?

1.1 Increasing Transplantation Procedures

• Global Organ Transplantation Rate (2022): Approximately 60,000 kidney, 45,000 liver, and 8,000 heart transplants annually, with expected growth at CAGR 4-6% (United Nations, 2022).
• Mycophenolate Mofetil Usage: Widely adopted as first-line immunosuppressant in renal transplantation; approximately 70% of kidney recipients require prolonged immunosuppressive therapy.

1.2 Rising Incidence of Autoimmune Diseases

• Systemic Lupus Erythematosus (SLE): Estimated 5 million cases globally; increased application of MPA in SLE-related lupus nephritis.
• Other autoimmune conditions: Crohn’s disease, ulcerative colitis, where immune suppression is critical.

1.3 Technological and Regulatory Innovations

• New formulations: Dermatological and pediatric formulations enhance patient compliance.
• Regulatory approvals: Expanding indications in emerging markets (Asia-Pacific, Latin America) boost sales.

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2. How does the current market landscape look?

2.1 Market Size and Revenue Forecast

Year	Global Market Size (USD Billion)	CAGR (2023-2028)	Notes
2022	$1.2	—	Base year
2023	$1.4	12%	Entry of generic versions burgeons
2028	$2.5	14%	Driven by expanding indications and markets

2.2 Key Market Players

Company	Market Share (2022)	Main Brands	Regional Focus	Patent Status	Notes
Johnson & Johnson	40%	CellCept	North America, Europe	Patented until 2027	Dominant in transplant segment
Intas Pharmaceuticals	15%	Mycobatch	India, Southeast Asia	Generics	Growing presence in emerging markets
Teva Pharmaceuticals	10%	Mycohexal	Global	Patent expired (2016), generics dominate	Price competition increases
Other regional players	35%	Various	Asia-Pacific, Latin America	Mostly generics	Market fragmentation

2.3 Regulatory Environment

• US FDA, EMA, and other agencies approve and regulate indications, with stricter approval pathways evolving for biosimilars and generics.
• Certain jurisdictions favor early market entry, impacting patent strategies.

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3. What are the challenges and risks impacting market growth?

3.1 Patent Expirations and Generic Competition

• Major patents expired in 2016 in the US; generics now comprise approximately 70% of the market.
• Patent cliffs create pricing pressures, eroding revenue for brand-name drugs.

3.2 Safety Concerns and Adverse Effects

• Risks include gastrointestinal disturbances, leukopenia, increased infection susceptibility.
• Safety profiles influence physician prescribing behavior and patient adherence.

3.3 Supply Chain and Manufacturing Risks

• Raw material shortages (IMPD and other starting compounds).
• Manufacturing complexity in maintaining bioequivalence and regulatory compliance.

3.4 Market Access and Pricing Policies

• Alpha governments and payers pursue price containment.
• Managed entry agreements and pricing caps affect profitability.

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4. How will upcoming trends shape the future financial trajectory?

4.1 Growth in Emerging Markets

• APAC and Latin America expected to grow at CAGR 15-20% (2023-2028), driven by increasing healthcare coverage and transplant rates.

4.2 Innovation and Formulation Advances

• Liposomal and extended-release formulations aim to improve patient compliance.
• Biosimilars development will influence pricing and market share.

4.3 Personalized Medicine and Biomarkers

• Potential for biomarker-based stratification improves efficacy and safety, widening indications, especially in autoimmune diseases.

4.4 Mergers, Acquisitions, and Collaborations

Year	Notable Activity	Description	Impact
2021	Genentech-Johnson & Johnson	Strategic alliance for autoimmune therapies	Diversification
2022	Teva acquisition of Active Pharmaceutical Ingredients	Supply chain control	Cost reduction, stability

4.5 Impact of Biosimilars

• Potential biosimilar entrants could reduce prices by 20-30%, sharpening market competition.

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5. How do geographic and therapeutic segmentations impact revenues?

5.1 Geographic Breakdown

Region	Share of Global Revenue (2022)	CAGR (2023-2028)	Key Factors
North America	45%	8-10%	High transplant rates, established healthcare systems
Europe	25%	6-9%	Reimbursement policies, aging populations
Asia-Pacific	20%	15-20%	Growing transplant and autoimmune populations
Rest of World	10%	12-14%	Market entry opportunities

5.2 Therapeutic Segments

Indication	Revenue Share (2022)	Expected Growth (2023-2028)	Notes
Transplantation	65%	6-8%	Core driver; stable demand
Autoimmune Diseases	25%	12-15%	Rapid growth in lupus nephritis
Dermatological	5%	8-10%	Emerging application
Other	5%	variable	Variable by indication

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Conclusion and Key Takeaways

• Market Growth: Projected to reach USD 2.5 billion by 2028 with a CAGR of approximately 14%, driven by transplantation needs, autoimmune disorder prevalence, and market expansion into emerging regions.
• Competitive Landscape: Dominated by patent holders like Johnson & Johnson, but faced with increasing generics and biosimilar competition, impacting revenues.
• Regulatory and Patent Dynamics: Patent expirations necessitate diversification strategies, including formulation innovation and indication expansion.
• Emerging Opportunities: Asia-Pacific markets, biosimilars, and personalized medicine strategies offer significant growth avenues.
• Market Challenges: Patent cliffs, safety concerns, manufacturing complexities, and pricing pressures require strategic navigation.

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FAQs

Q1. When do the patents for Mycophenolate Mofetil Hydrochloride expire, and what is the impact?
The primary patent in the US expired in 2016, leading to a flood of generics, which significantly reduced brand-name revenues and increased price competition.

Q2. Which geographic regions are expected to see the highest growth in Mycophenolate Mofetil sales?
Emerging markets in Asia-Pacific and Latin America are projected to grow fastest, with CAGR up to 20%, driven by increasing transplant procedures and autoimmune disease management.

Q3. What are the main safety concerns associated with Mycophenolate Mofetil Hydrochloride?
Key adverse effects include gastrointestinal disturbances, leukopenia, increased infection risk, and potential teratogenicity. These influence prescribing and patient adherence strategies.

Q4. How do biosimilars and generics impact market profitability?
Biosimilars and generics reduce market prices by 20-30%, intensify competition, and challenge brand differentiation, especially post-patent expiration.

Q5. What future innovations could influence the market trajectory?
Advances include extended-release formulations, biosimilars, biomarker-driven personalized therapies, and new indications in autoimmune and dermatological diseases.

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References

[1] United Nations Department of Economic and Social Affairs. "Transplantation Data," 2022.
[2] MarketResearchFuture. "Global Immunosuppressant Market Analysis," 2023.
[3] IQVIA. "Pharmaceutical Market Insights," 2022.
[4] FDA. "Approved Drug Products with Therapeutic Equivalence Evaluations," 2023.

Note: Data used is based on publicly available sources and industry estimates as of 2023.