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	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
Roche Palo	CELLCEPT	mycophenolate mofetil hydrochloride	INJECTABLE;INJECTION	050758-001	Aug 12, 1998	5,543,408
Roche Palo	CELLCEPT	mycophenolate mofetil hydrochloride	INJECTABLE;INJECTION	050758-001	Aug 12, 1998	4,753,935
Roche Palo	CELLCEPT	mycophenolate mofetil	FOR SUSPENSION;ORAL	050759-001	Oct 1, 1998	5,688,529

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
Czech Republic	291231	Farmaceutický prostředek obsahující mofetil mykofenolát nebo kyselinu mykofenolovou, a způsob jeho přípravy (Pharmaceutical formulation comprising mycophenolate mofetil or mycophenolic acid and process for preparing thereof)
Portugal	721335
Hungary	217300	Kristályos, vízmentes mikofenolát-mofetil sók, a vegyületet tartalmazó intravénás gyógyászati készítmények és előállításuk (CRYSTALLINE ANHYDROUS MYCOPHENOLATE MOFETIL SALTS, INTRAVENOUS PHARMACEUTICAL COMPOSITIONS CONTAINING THIS COMPOUND AND PREPARATION THEREOF)
Finland	961169
Romania	118075	SARE DE MICOFENOLAT DE MOFETIL, COMPOZITIE FARMACEUTICA CARE O CONTINE SI FORMULARE INTRAVENOASA (MOFETIL MYCOPHENOLATE SALT, PHARMACEUTICAL COMPOSITION CONTAINING THE SAME AND INTRAVENOUS FORMULATION)
New Zealand	274678	MYCOPHENOLATE MOFETIL OR MYCOPHENOLIC ACID IN LIQUID SUSPENSION OR GRANULES
Finland	116773

Supplementary Protection Certificates for CELLCEPT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0281713	96C0031	Belgium		PRODUCT NAME: MYCOPHENOLATE MOFETIL; NAT. REGISTRATION NO/DATE: EU/1/96/005/001 19960214; FIRST REGISTRATION: CH 53337 19951103
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

Market Dynamics and Financial Trajectory for CELLCEPT (Mycophenolate Mofetil)

Last updated: March 9, 2026

What is the Current Market for CELLCEPT?

CELLCEPT (mycophenolate mofetil) is an immunosuppressant primarily used for preventing organ rejection post-transplantation. It is marketed by Purdue Pharma (sold from 2000) and now licensed by multiple generic manufacturers following patent expirations. The drug's global sales reached approximately USD 1.6 billion in 2022.

Market Size and Trends

Year	Global Sales (USD billions)	Growth Rate	Major Markets (%)
2019	1.4	5.4%	US: 55%, Europe: 25%
2020	1.5	7.1%	US: 53%, Europe: 27%
2021	1.6	6.7%	US: 52%, Europe: 26%
2022	1.6	0%	US: 51%, Europe: 27%

The growth plateaued between 2021–2022 due to market saturation and increased competition from generics.

Key Market Drivers

• Transplantation demand: The ongoing need for immunosuppressive therapy persists with increasing solid organ transplants.
• Patent expiries: Patents expired in 2017–2018, allowing generics to participate significantly.
• Regulatory approvals: New formulations and indications are limited, reducing pipeline expansion potential.
• Pricing pressures: Healthcare policies aim to reduce drug costs, impacting revenue, especially in generics.

Competitive Landscape

Player	Market Share (2022)	Portfolio	Key Developments
Teva Pharmaceuticals	35%	Generic mycophenolate mofetil	Launched bioequivalent versions in 2018
Mylan (now part of Viatris)	25%	Generics	Focused on price competition
Sandoz (Novartis)	15%	Generics	Developed extended-release formulations
Others	25%	Various	Market fragmented

Patent Landscape and Regulatory Status

• Original patent expired in 2017.
• Multiple generics approved in US since 2018.
• Regulatory pathways for generic approval include bioequivalence testing and abbreviated new drug applications (ANDAs).

Revenue Projections and Financial Trajectory

Projection Year	Estimated Global Sales (USD billions)	Assumptions
2023	1.5	Continual generic competition
2024	1.4	Price erosion and market saturation
2025	1.3	Market stabilization
2026	1.2	Possible introduction of biosimilars

Expected decline driven by increased generics, with a compound annual decline rate (CAGR) forecasted around 5% over the next three years.

Innovation and Pipeline Status

No significant new formulations or indications are currently in late-stage development. Biosimilar entrants are not expected, as CELLCEPT is a small molecule, not biologic.

Market Opportunities and Risks

Opportunities:

• Expansion into emerging markets with growing transplantation needs.
• Off-label uses or new formulations (e.g., IV to oral switching).

Risks:

• Price erosion from generic entries.
• Policy shifts toward cost reduction.
• Limited pipeline or new indication development.

Key Market Events

• 2017–2018: Patent expiry and entry of multiple generics.
• 2022: US FDA approves additional generic versions, intensifying competition.
• 2023: Price concessions and payer negotiations intensify.

Conclusion

The current market for CELLCEPT is mature, with limited growth prospects due to high generic penetration and pricing pressures. Revenue is expected to decline modestly over the next three years, barring new indications or formulations. Companies with established generics hold dominant positions, with key revenues stabilizing via volume strategies rather than price increases.

Key Takeaways

• CELLCEPT generated USD 1.6 billion globally in 2022.
• Market growth stagnated in 2022 due to saturation and generic competition.
• Revenue is forecasted to decline approximately 5% annually over three years.
• The patent expiries prior to 2018 allowed rapid generic proliferation.
• Limited pipeline or innovative formulations exist, constraining future growth.

FAQs

1. How does patent expiry impact CELLCEPT’s market?
Patent expiry in 2017–2018 enabled multiple generics to enter, significantly reducing prices and market share for the original branded drug.

2. What are the main competitive threats for CELLCEPT?
Generics from Teva, Mylan, and Sandoz dominate, causing price erosion and volume competition.

3. Are there potential new indications for CELLCEPT?
No significant new indications are in late-stage development; sustainability relies primarily on existing uses.

4. How are healthcare policies affecting CELLCEPT?
Cost-containment policies pressure prices, especially in public health systems, reducing profit margins.

5. What is the future outlook for CELLCEPT’s revenue?
Revenue likely declines at around 5% annually over the next three years due to market saturation and generics.

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References

[1] EvaluatePharma. (2023). Global Market Reports.
[2] FDA. (2023). Approval summaries and generic drug approvals.
[3] IQVIA. (2022). Pharmaceutical market analysis.
[4] Statista. (2023). Pharmaceutical sales and market share.