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. Eleven 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 ENDO OPERATIONS 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:	152
Clinical Trials:	386
Patent Applications:	4,341
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
National Cord Blood Network	Phase 2
Fred Hutchinson Cancer Center	Phase 2
The University of Hong Kong	Phase 2

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 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/001218 Myclausen 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/000082 CellCept 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/000884 Myfenax 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/000882 Mycophenolate 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
Israel	110970	Crystalline anhydrous mycophenolate mofetil pharmaceutical composition containing it and its preparation
Finland	875502
Poland	178522
South Africa	9407683
Poland	177323

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	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

CELLCEPT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Cellcept (Mycophenolate Mofetil)

Introduction to Cellcept (Mycophenolate Mofetil)

Cellcept, also known as mycophenolate mofetil (MMF), is an immunosuppressive medication primarily used to prevent the rejection of transplanted organs and to treat various autoimmune diseases. Here, we will delve into the market dynamics and financial trajectory of Cellcept.

Market Size and Growth Projections

The global mycophenolate mofetil market has been experiencing significant growth. As of 2023, the market size was valued at USD 5.2 billion and is projected to reach USD 9.84 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 4.9% from 2024 to 2031[1].

Another report indicates that the market size was USD 1487.9 million in 2021 and is expected to reach USD 2735.54 million by 2031, exhibiting a CAGR of 6.28%[3].

Key Drivers of Market Growth

Several factors are driving the growth of the mycophenolate mofetil market:

Increasing Need for Immunosuppressive Treatments

The growing number of organ transplants globally has increased the demand for efficient immunosuppressive treatments. MMF is a crucial component in this context, contributing significantly to the market's expansion[1].

Rising Prevalence of Autoimmune Diseases

The increasing prevalence of autoimmune diseases such as systemic lupus erythematosus (SLE), rheumatoid arthritis, and others has boosted the demand for MMF. Its effectiveness in treating these conditions has made it a preferred choice among healthcare providers[1][5].

Advances in Pharmaceutical Formulations

Improvements in pharmaceutical formulations and drug delivery technologies have enhanced the accessibility and effectiveness of MMF, further driving market growth[1].

Favorable Reimbursement Policies

Advances in healthcare infrastructure and favorable reimbursement regulations have also contributed to the increased adoption of MMF, making it more accessible to patients[1].

Market Segmentation

The mycophenolate mofetil market is segmented based on several criteria:

Application

The market is segmented into various applications, including pemphigus, bullous pemphigoid, systemic lupus erythematosus (SLE), psoriasis, and other autoimmune diseases[1].

Product Form

MMF is available in different forms such as tablets, capsules, topical suspension, injections, and others. Each form caters to different patient needs and preferences[1].

Geographical Regions

The market is analyzed across various geographical regions, including North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. North America currently dominates the market due to the presence of major key players and well-developed healthcare infrastructure[1][5].

Competitive Landscape

The mycophenolate mofetil market is highly competitive, with several key players:

• Roche
• Alkem Laboratories
• Genentech
• Sandoz (Novartis)
• West Ward Pharmaceuticals
• Teva
• Strides Pharma
• Accord Healthcare
• Jubilant Cadista
• Mylan
• Shandong Xinshidai
• Kunming Fengkenuo Pharmaceutical
• Wuxi Hequan Pharmaceutical
• Akorn
• Sinopharm Group
• **Par Pharmaceut[1][3].

Financial Assistance and Patient Access Programs

Given the high cost of MMF, several financial assistance and patient access programs are available to help patients afford the medication:

• Simplefill: This program helps patients by engaging with patient assistance and discount programs to reduce the cost of Cellcept[2].
• CellCept Co-pay Card: For patients with commercial insurance, this program can reduce the monthly cost of CellCept to as little as $15[4].

Side Effects and Safety Considerations

While MMF is effective, it comes with significant side effects and safety considerations:

• Birth Defects and Miscarriage: Women taking MMF have a higher risk of miscarriage and birth defects[2][4].
• Increased Risk of Infections and Cancers: MMF weakens the immune system, increasing the risk of serious infections and certain cancers[4].

Market Analysis and Insights

Porter’s Five Forces Analysis

The market analysis includes a Porter’s Five Forces analysis, which examines the bargaining power of buyers and suppliers, the threat of new entrants, the threat of substitutes, and the degree of competition in the market. This analysis provides a comprehensive understanding of the market dynamics and competitive landscape[1].

Patient Epidemiology Analysis

The market growth is also influenced by patient epidemiology, including the prevalence of diseases treated by MMF and the demographics of the patient population. This analysis helps in forecasting the market scenario for individual countries and regions[5].

Key Takeaways

• The mycophenolate mofetil market is expected to grow significantly, driven by the increasing need for immunosuppressive treatments and the rising prevalence of autoimmune diseases.
• Advances in pharmaceutical formulations and favorable reimbursement policies are additional drivers of market growth.
• The market is highly competitive, with several key players, and is segmented based on application, product form, and geographical regions.
• Financial assistance programs are crucial for patient access due to the high cost of the medication.
• MMF comes with significant side effects and safety considerations that need to be carefully managed.

FAQs

What is the projected market size of the mycophenolate mofetil market by 2031?

The mycophenolate mofetil market is expected to reach USD 9.84 billion by 2031, growing at a CAGR of 4.9% from 2024 to 2031[1].

What are the primary drivers of the mycophenolate mofetil market growth?

The primary drivers include the growing need for immunosuppressive treatments, the rising prevalence of autoimmune diseases, advances in pharmaceutical formulations, and favorable reimbursement policies[1][5].

Which regions dominate the mycophenolate mofetil market?

North America currently dominates the market due to the presence of major key players and well-developed healthcare infrastructure. However, the Asia-Pacific region is expected to grow significantly during the forecast period[1][5].

What are the common side effects of mycophenolate mofetil?

Common side effects include increased risk of miscarriage and birth defects, higher risk of infections, and increased risk of certain cancers such as lymphoma and skin cancer[2][4].

Are there any financial assistance programs available for patients taking mycophenolate mofetil?

Yes, programs like Simplefill and the CellCept Co-pay Card are available to help patients afford the medication[2][4].

Sources

1. MarketResearchIntellect: Mycophenolate Mofetil (MMF) Market Size, Trends and Projections.
2. Simplefill: Cellcept Patient Assistance Programs.
3. BusinessResearchInsights: Mycophenolate Mofetil Market Size, Share | 2024 To 2031.
4. CellCept: Co-pay Card Eligibility | CellCept® (mycophenolate mofetil).
5. DataBridgeMarketResearch: Global Mycophenolate Market - Industry Trends and Forecast to 2029.