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, Teva Pharms, Zhejiang Hisun Pharm, Zydus Pharms Usa Inc, Amneal, Lannett Co Inc, Teva Pharms Usa, Vistapharm, Azurity, Apotex, Aurobindo Pharma, Bpi Labs, Endo Operations, Meitheal, Mylan Labs Ltd, Rising, Steriscience Speclts, and Zydus Pharms, and is included in fifty-three NDAs. There are three 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:	3
Tradenames:	4
Applicants:	30
NDAs:	53
Drug Master File Entries:	29
Finished Product Suppliers / Packagers:	31
Raw Ingredient (Bulk) Api Vendors:	152
Clinical Trials:	954
Patent Applications:	7,690
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
Fred Hutchinson Cancer Center	Phase 2
National Cord Blood Network	Phase 2
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China	Phase 1

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
Apotex	MYCOPHENOLATE MOFETIL	mycophenolate mofetil	TABLET;ORAL	090499-001	Apr 22, 2009		DISCN	No	No
Sandoz	MYCOPHENOLATE MOFETIL	mycophenolate mofetil	TABLET;ORAL	065451-001	Oct 15, 2008	AB	RX	No	No
Sandoz	MYCOPHENOLATE MOFETIL	mycophenolate mofetil	CAPSULE;ORAL	065379-001	Oct 15, 2008	AB	RX	No	No
Teva Pharms	MYCOPHENOLATE MOFETIL	mycophenolate mofetil	TABLET;ORAL	065457-001	May 4, 2009		DISCN	No	No
Accord Hlthcare	MYCOPHENOLATE MOFETIL	mycophenolate mofetil	TABLET;ORAL	065416-001	May 4, 2009	AB	RX	No	No
Azurity	MYHIBBIN	mycophenolate mofetil	SUSPENSION;ORAL	216482-001	May 1, 2024		RX	Yes	Yes	12,097,284		Y

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	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	FOR SUSPENSION;ORAL	050759-001	Oct 1, 1998	5,688,529

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/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 mycophenolate mofetil

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

Supplementary Protection Certificates for mycophenolate mofetil

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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

Mycophenolate mofetil Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Mycophenolate Mofetil (MMF)

Introduction to Mycophenolate Mofetil (MMF)

Mycophenolate mofetil (MMF) is a potent immunosuppressive medication widely used in the prevention of organ rejection in transplant patients and the treatment of various autoimmune diseases. Its efficacy and broad application have made it a cornerstone in modern medical treatment.

Market Size and Growth Projections

The global Mycophenolate Mofetil market is 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][4].

Key Drivers of Market Growth

Increasing Organ Transplants

The rising number of organ transplants globally is a major driver of the MMF market. As organ transplantation rates increase, so does the demand for effective immunosuppressive treatments like MMF to prevent organ rejection[1][4].

Growing Prevalence of Autoimmune Diseases

The increasing prevalence of autoimmune diseases such as systemic lupus erythematosus (SLE), rheumatoid arthritis, and psoriasis also contributes to the market's expansion. MMF's proven efficacy in treating these conditions makes it a preferred choice among healthcare providers[1][4].

Advances in Pharmaceutical Formulations

Continuous improvements in pharmaceutical formulations, including new drug delivery methods and extended-release formulations, enhance the therapeutic profile of MMF. These advancements make the drug more accessible and effective, further driving market growth[1][4].

Favorable Reimbursement Policies and Healthcare Infrastructure

Enhancements in healthcare infrastructure and favorable reimbursement policies in various regions increase the accessibility and affordability of MMF, contributing to its market adoption[1][4].

Market Segmentation

The MMF market is segmented based on several criteria:

Application

• Organ Transplantation: MMF is crucial in preventing organ rejection after transplantation.
• Autoimmune Diseases: It is used to treat conditions like SLE, rheumatoid arthritis, and psoriasis[1][4].

Product Forms

• Tablets
• Capsules
• Topical Suspension
• Injection
• Other forms such as oral suspensions[1][4].

Geographical Regions

• North America
• Europe
• Asia-Pacific
• South America
• Middle-East and Africa[1][4].

Economic and Cost-Effectiveness Analysis

Cost Savings in Transplantation

Studies have shown that MMF is cost-effective in the first year after transplantation. It reduces the incidence of acute graft rejection, leading to lower treatment costs for rejection and related complications. For instance, patients treated with MMF had lower rejection-related treatment costs and improved graft survival, resulting in overall lower first-year costs compared to standard therapy[2].

Cost Utility in Autoimmune Diseases

In the treatment of autoimmune diseases like neuromyelitis optica spectrum disorder (NMOSD), MMF has been found to be cost-effective, especially when compared to other treatments like azathioprine. The use of generic MMF can result in significant cost savings and improved health outcomes, making it a viable option for patients resistant to conventional therapies[5].

Competitive Landscape

The MMF market is characterized by a competitive landscape with several major players. These companies are involved in continuous research and development to enhance the therapeutic potential of MMF. The report includes a detailed analysis of the financial statements, key developments, product benchmarking, and SWOT analysis of these major players[1][4].

Porter’s Five Forces Analysis

The market dynamics are further analyzed using Porter’s Five Forces model, which includes:

• Buyers’ Bargaining Power: The ability of buyers to influence prices and terms.
• Suppliers’ Bargaining Power: The ability of suppliers to influence prices and terms.
• Threat of New Entrants: The ease with which new companies can enter the market.
• Threat of Substitutes: The availability of alternative treatments.
• Degree of Competition: The intensity of competition among existing market players[1].

Regional Market Analysis

The MMF market varies significantly across different geographical regions. North America and Europe are among the leading markets due to advanced healthcare infrastructure and high adoption rates of MMF. However, the Asia-Pacific region is expected to show significant growth due to increasing healthcare expenditures and rising awareness about autoimmune diseases[1][4].

Challenges and Opportunities

Challenges

• Regulatory Hurdles: Strict regulatory environments can slow down the approval and launch of new MMF formulations.
• Competition from Generics: The presence of generic versions of MMF can reduce the market share of branded products.
• Side Effects and Safety Concerns: MMF can have side effects, which may impact its adoption rates[1][4].

Opportunities

• Emerging Markets: Developing regions offer significant growth opportunities due to improving healthcare infrastructure and increasing demand for immunosuppressive treatments.
• New Therapeutic Uses: Ongoing research into new therapeutic applications of MMF can expand its market potential.
• Strategic Partnerships: Collaborations between pharmaceutical companies and healthcare institutions can enhance drug availability and affordability[1][4].

Key Takeaways

• The global MMF market is projected to grow significantly, driven by increasing organ transplants and the prevalence of autoimmune diseases.
• Advances in pharmaceutical formulations and favorable reimbursement policies are key drivers of market growth.
• MMF is cost-effective in both transplantation and the treatment of autoimmune diseases.
• The competitive landscape is characterized by major players investing in R&D to enhance MMF's therapeutic potential.
• Regional markets vary, with North America and Europe leading, but the Asia-Pacific region showing promising growth.

FAQs

Q: What is the current market size of the Mycophenolate Mofetil (MMF) market?

A: The MMF market was valued at USD 5.2 billion in 2023[1].

Q: What is the projected growth rate of the MMF market from 2024 to 2031?

A: The MMF market is expected to grow at a CAGR of 4.9% from 2024 to 2031[1].

Q: What are the primary applications of Mycophenolate Mofetil?

A: The primary applications include organ transplantation and the treatment of autoimmune diseases such as SLE, rheumatoid arthritis, and psoriasis[1][4].

Q: How does MMF impact the cost of treatment in organ transplantation?

A: MMF reduces the incidence of acute graft rejection, leading to lower treatment costs for rejection and related complications, thus making it cost-effective in the first year after transplantation[2].

Q: Is MMF cost-effective in treating autoimmune diseases?

A: Yes, MMF has been found to be cost-effective in treating autoimmune diseases like NMOSD, especially when compared to other treatments like azathioprine[5].

Sources

1. Market Research Intellect, "Global Mycophenolate Mofetil (MMF) Market Size and Forecast," December 2024.
2. PubMed, "The cost effectiveness of mycophenolate mofetil in the first year after cadaveric renal transplantation," 1997.
3. Coherent Market Insights, "Autoimmune Hepatitis Market - Report, Trends, Share & Insights," 2024.
4. Market Research Intellect, "Mycophenolate Mofetil Market Size, Share, Growth Drivers, and Forecast," December 2024.
5. PubMed, "Cost effectiveness of rituximab and mycophenolate mofetil in patients with neuromyelitis optica spectrum disorder resistant to azathioprine," 2020.