CELLCEPT Drug Patent Profile

Which patents cover Cellcept, and when can generic versions of Cellcept launch?

Cellcept is a drug marketed by Roche Palo and is included in four NDAs.

The generic ingredient in CELLCEPT is mycophenolate mofetil hydrochloride. There are thirty-eight drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the mycophenolate mofetil hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Cellcept

A generic version of CELLCEPT was approved as mycophenolate mofetil hydrochloride by PH HEALTH on October 28^th, 2016.

Summary for CELLCEPT

US Patents:	0
Applicants:	1
NDAs:	4
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	390
Drug Prices:	Drug price information for CELLCEPT
What excipients (inactive ingredients) are in CELLCEPT?	CELLCEPT excipients list
DailyMed Link:	CELLCEPT at DailyMed

See drug prices for CELLCEPT

See drug sales revenues for CELLCEPT

Recent Clinical Trials for CELLCEPT

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

Sponsor	Phase
University Hospital, Limoges	PHASE4
National Institute of Allergy and Infectious Diseases (NIAID)	PHASE2
Nantes University Hospital	PHASE2

See all CELLCEPT clinical trials

Pharmacology for CELLCEPT

Drug Class

Antimetabolite Immunosuppressant

Paragraph IV (Patent) Challenges for CELLCEPT

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 CELLCEPT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Roche Palo	CELLCEPT	mycophenolate mofetil	CAPSULE;ORAL	050722-001	May 3, 1995	AB	RX	Yes	Yes
Roche Palo	CELLCEPT	mycophenolate mofetil	TABLET;ORAL	050723-001	Jun 19, 1997	AB	RX	Yes	Yes
Roche Palo	CELLCEPT	mycophenolate mofetil	FOR SUSPENSION;ORAL	050759-001	Oct 1, 1998	AB	RX	Yes	Yes
Roche Palo	CELLCEPT	mycophenolate mofetil hydrochloride	INJECTABLE;INJECTION	050758-001	Aug 12, 1998	AP	RX	Yes	Yes

Expired US Patents for CELLCEPT

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	5,543,408
Roche Palo	CELLCEPT	mycophenolate mofetil	CAPSULE;ORAL	050722-001	May 3, 1995	4,753,935
Roche Palo	CELLCEPT	mycophenolate mofetil	TABLET;ORAL	050723-001	Jun 19, 1997	4,753,935
Roche Palo	CELLCEPT	mycophenolate mofetil	FOR SUSPENSION;ORAL	050759-001	Oct 1, 1998	4,753,935

EU/EMA Drug Approvals for CELLCEPT

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 CELLCEPT

See the table below for patents covering CELLCEPT around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	7723894
Russian Federation	2150942	ORAL SUSPENSION CONTAINING HIGH DOSE OF MOFETIL MYCOPHENOLATE
Portugal	721335
World Intellectual Property Organization (WIPO)	9509626

Supplementary Protection Certificates for CELLCEPT

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
0281713	C960019	Netherlands		PRODUCT NAME: MYCOFENOLAAT MOFETIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTIS CH AANVAARDBAAR ZOUT, OF IN DE VORM VAN EEN ESTER MET EEN CARBO NZUUR MET DE FORMULE RCOOH WAARIN R EEN ALKYL- OF CYCLOALKYLGRO EP MET 1-6 KOOLSTOFATOMEN IS OF EEN UIT AL DAN NIET GESUBSTITUE; REGISTRATION NO/DATE: EU/1/96/005/001 - EU/1/96/005/002 19960214, IKS 53337-01 19951103

Market Dynamics and Financial Trajectory for CELLCEPT (Mycophenolate Mofetil)

Last updated: December 29, 2025

Summary

CELLCEPT, with the generic name mycophenolate mofetil, is an immunosuppressive drug primarily used to prevent organ transplant rejection, especially in kidney, liver, and heart transplants. Since its approval by the U.S. Food and Drug Administration (FDA) in 1995, CELLCEPT has established a robust market position, driven by expanding transplant procedures and evolving immunosuppressive regimens. This report examines its current market landscape, key drivers, competitive positioning, revenue trajectories, and future market outlook, offering an in-depth analysis for stakeholders evaluating its commercial and therapeutic prospects.

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What Are the Core Market Drivers for CELLCEPT?

1. Rising Organ Transplant Volumes

• Global organ transplantation procedures have increased annually, with kidney transplants leading (~60%).
• The International Society of Nephrology reports an average of approximately 150,000 kidney transplants annually worldwide (2020).
• Growing transplant rates directly correlate with sustained demand for immunosuppressive therapies like CELLCEPT.

2. Expanding Indications & Therapeutic Shift

• Primarily used for preventing rejection in solid organ transplants, but emerging indications include autoimmune diseases such as lupus nephritis.
• Shifts toward triple immunosuppressive regimens incorporating CELLCEPT enhance its relevance.

3. Patent Expiry and Generic Competition

• U.S. patent for CELLCEPT expired in 2012, resulting in immediate generic entry.
• Generics currently account for the majority of sales but face pricing pressures.

4. Regulatory Approvals & Pipeline Developments

• Recent approvals for biosimilars and related immunosuppressants could influence market share.
• Ongoing studies exploring new formulations or combinations could extend its therapeutic life cycle.

5. Biopharmaceutical Market Trends

• The growth in personalized immunotherapy warrants attention but is presently limited for CELLCEPT's class.

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What Are the Key Market Challenges for CELLCEPT?

1. Intensity of Generic Competition & Price Erosion

Year	Market Share (U.S.)	Average Price (per 500 mg)	Price Trend (CAGR)
2010	70% (brand)	$200	-
2015	40% (brand)	$150	-2%
2020	15% (brand)	$130	-4% (generic price decline)

Price erosion post-patent expiry has significantly affected revenue, especially as generics dominate.

2. Side Effect Profile & Safety Concerns

• Associated with hematological, gastrointestinal, and infectious adverse events, impacting prescribing patterns.
• Off-label use remains limited due to safety concerns.

3. Competition from Novel Immunosuppressants

Competitor	Drug Name	Approval Year	Price (USD/month)	Indication	Market Position
Novartis	Everolimus	2009	$5,000	Transplant, Oncology	Major competitor
Roche	Sirolimus	1999	$4,500	Transplant	Secondary option

Emerging drugs with better safety profiles threaten CELLCEPT's dominance.

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Financial Trajectory: Historical and Projected Revenues

Historical Revenue Trends (2020–2022)

Year	Global Sales (USD millions)	Key Markets	Growth Rate	Remarks
2020	~$550	US, Europe, Countries with high transplant rates	-	Impacted by COVID-19
2021	~$600	Slight recovery	+9%	Increased transplant activity
2022	~$650	Continued growth	+8.3%	Stronger market recovery

Projected Revenue Outlook (2023–2028)

Year	Estimated Revenue (USD millions)	Assumptions	Key Factors
2023	$700–750	Gradual market stabilization	Market growth, biosimilars
2025	$800–900	Adoption of biosimilars, new formulations	Patent landscape, pricing
2028	$900–1,000	Potential biosimilar competition intensifies	Market expansion, indications

Drivers Behind Revenue Trajectory

• Market Growth: Estimated compounded annual growth rate (CAGR) of 4–6% over the next five years fueled by transplant rates.
• Pricing Dynamics: Continued pressure from generic and biosimilar entries.
• Market Penetration: Increasing use in autoimmune conditions could supplement revenue streams.

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How Do Competitive and Regulatory Landscapes Impact Future Market Trajectory?

Regulatory Policies

Region	Policy Focus	Impact
U.S.	FDA regulations for biosimilars	Accelerated approval pathways could introduce biosimilars, reducing costs
EU	EMA biosimilar guidelines	Similar influence, fostering biosimilar market entry

Intellectual Property & Patent Landscape

Patent Expiry	Year	Impact
Original patent	2012	Entry of generics and biosimilars
Secondary patents	Varies	Limited extension, but potential patent challenges

Market Access & Reimbursement

• Reimbursement policies strongly influence prescribing behavior, especially in high-cost settings.
• Payer discounts and formulary placements impact revenue, requiring strategic market access planning.

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Comparison: CELLCEPT vs. Key Competitors

Feature	CELLCEPT	Everolimus	Sirolimus	Basiliximab
Mechanism	Mycophenolate Mofetil	mTOR inhibitor	mTOR inhibitor	IL-2 receptor antagonist
Approved Use	Transplant rejection	Transplant + Oncology	Transplant	Induction therapy
First Approval	1995	2009	1999	1998
Price (USD/month)	~$130–200 (Brand)	~$5,000	~$4,500	~$3,000
Safety Profile	Hematologic, GI, infections	Wound healing, infections	Wound healing, infections	Allergic reactions
Origin	Synthetic	Synthetic	Synthetic	Biological

Implication: While CELLCEPT remains a cornerstone, competition from targeted immunosuppressants and biologics presents a long-term challenge requiring strategic differentiation.

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Future Outlook and Strategic Considerations

Aspect	Outlook	Strategic Opportunities
Market Expansion	Steady growth, especially in emerging markets	Expand access and partnership models
Biosimilars	Entry expected by mid-2020s	Prepare for biosimilar competition with value-based strategies
Indication Expansion	Autoimmune diseases	Investment in clinical research
Formulation Innovation	IV-to-oral switches, sustained-release	Enhance patient compliance
Pricing & Access	Rising importance	Develop pricing strategies aligned with payer expectations

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Key Takeaways

• Growing Organ Transplantation sustains baseline demand for CELLCEPT, though the market faces significant pressures from generics and biosimilars.
• Patent expiries and biosimilar competition are key factors influencing revenue trajectory, necessitating strategic adaptation.
• Pricing pressures and safety concerns shape prescribing behaviors and reimbursement frameworks.
• Future growth hinges on expanding indications, formulations, and geographic markets, alongside proactive market access strategies.
• Competitive landscape demands readiness to innovate and differentiate, especially as novel immunosuppressants and biologics gain prominence.

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FAQs

Q1: How will biosimilars impact CELLCEPT’s market share?
A: Biosimilars are expected to enter by mid-2020s, likely reducing prices and market share for the original molecule. Strategic planning around cost leadership and differentiation will be critical.

Q2: What are the primary open indications beyond transplantation?
A: Autoimmune diseases such as lupus nephritis and certain dermatological conditions are under investigation, with some approvals expanding the drug's therapeutic scope.

Q3: How does safety profile influence prescribing patterns?
A: Adverse effects like cytopenias and infections necessitate careful patient monitoring, which can influence clinician preferences towards alternative agents in some cases.

Q4: What is the expected impact of regulatory policies on future revenues?
A: Regulatory encouragement for biosimilars and streamlined approval processes may accelerate biosimilar market entries, pressuring prices and revenues of CELLCEPT.

Q5: What strategic moves should manufacturers consider to sustain growth?
A: Investing in formulation innovation, expanding clinical indications, developing biosimilars, and exploring emerging markets will be pivotal.

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References

[1] International Society of Nephrology. "Global Kidney Transplant Data," 2020.

[2] U.S. Food and Drug Administration. "Mycophenolate Mofetil (CELLCEPT) FDA Approval," 1995.

[3] EvaluatePharma. "Biopharma Market Reports," 2022.

[4] IQVIA. "Global Immunosuppressant Market Analysis," 2021.

[5] European Medicines Agency. "Biosimilar Guidelines," 2017.

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In conclusion, CELLCEPT remains a vital component in transplant immunosuppression with a resilient revenue outlook, tempered by competitive pressures. Strategic adaptation to dynamic regulatory, pricing, and competitive landscapes will be essential for sustaining growth and maintaining market relevance.