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, Endo Operations, Meitheal, Mylan Labs Ltd, Rising, Steriscience Speclts, 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. Eleven 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:	11
Raw Ingredient (Bulk) Api Vendors:	25
Clinical Trials:	954
Patent Applications:	231
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
National Cord Blood Network	Phase 2
Fred Hutchinson Cancer Center	Phase 2
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China	Phase 1

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
Endo Operations	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	mycophenolate mofetil hydrochloride	INJECTABLE;INJECTION	203575-001	Oct 28, 2016	AP	RX	No	No
Meitheal	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	mycophenolate mofetil hydrochloride	INJECTABLE;INJECTION	212130-001	Jan 15, 2021	AP	RX	No	No
Roche Palo	CELLCEPT	mycophenolate mofetil hydrochloride	INJECTABLE;INJECTION	050758-001	Aug 12, 1998	AP	RX	Yes	Yes

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	4,753,935
Roche Palo	CELLCEPT	mycophenolate mofetil hydrochloride	INJECTABLE;INJECTION	050758-001	Aug 12, 1998	5,543,408

MYCOPHENOLATE MOFETIL HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Mycophenolate Mofetil Hydrochloride

Market Overview

Mycophenolate mofetil hydrochloride, commonly known as mycophenolate mofetil (MMF), is a crucial immunosuppressive medication used primarily in the prevention of organ rejection in transplant patients and the treatment of various autoimmune diseases. Here’s a detailed look at the market dynamics and financial trajectory of this drug.

Market Size and Growth Projections

The global mycophenolate mofetil market has been valued at significant levels and is expected to grow substantially in the coming years. As of 2023, the market size was estimated at USD 18 billion and is projected to reach USD 24.63 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 5.3% from 2024 to 2031[1].

Another report indicates a slightly different valuation but aligns with the growth trend, stating the market size was USD 5.2 billion in 2023 and is expected to reach USD 9.84 billion by 2031, with a CAGR of 4.9% from 2024 to 2031[4].

Key Drivers of Market Growth

Increasing Organ Transplants

The rising global rates of kidney, liver, and heart transplants are a significant driver of the market. As the number of organ transplants increases, so does the demand for effective immunosuppressive medications like MMF to prevent organ rejection[1][4].

Prevalence of Autoimmune Diseases

The growing prevalence of autoimmune diseases such as rheumatoid arthritis, lupus nephritis, and other conditions further boosts the demand for MMF. The drug's effectiveness in controlling these diseases makes it a preferred choice among physicians[1][4].

Advances in Formulation Technology

Continuous developments in pharmaceutical formulations, including combination therapies and extended-release formulations, enhance the accessibility and effectiveness of MMF. These advancements contribute to the market's expansion by improving the therapeutic profile of the drug[1][4].

Healthcare Infrastructure and Reimbursement

Improvements in healthcare infrastructure in developing nations and favorable reimbursement regulations also play a crucial role in increasing the market adoption of MMF. These factors make the drug more accessible to a broader patient population[4].

Market Segmentation

The mycophenolate mofetil market is segmented based on several factors:

Application

The market is segmented by application, including pemphigus, bullous pemphigoid, systemic lupus erythematosus (SLE), psoriasis, and other autoimmune diseases. This segmentation helps in understanding the specific demand drivers and market opportunities in each therapeutic area[4].

Product Form

The market is also segmented by product form, which includes tablets, capsules, topical suspension, injection, and other formulations. This segmentation highlights the preferences and needs of different patient groups and healthcare providers[4].

Geographical Regions

The market is analyzed across various geographical regions, including North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. This regional segmentation provides insights into the market dynamics and growth opportunities in different parts of the world[4].

Competitive Landscape

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

Porter’s Five Forces Analysis

A Porter’s Five Forces analysis is conducted to understand the market dynamics better. This analysis includes:

• Buyers' Bargaining Power: The power of buyers, such as hospitals and healthcare institutions, to negotiate prices and terms.
• Suppliers' Bargaining Power: The influence of suppliers, such as raw material providers and manufacturing partners, on the market.
• Threat of New Entrants: The ease or difficulty with which new companies can enter the market.
• Threat of Substitutes: The availability and attractiveness of alternative immunosuppressive medications.
• Degree of Competition: The level of competition among existing market players[4].

Financial Performance and Projections

The financial performance of the mycophenolate mofetil market is robust and expected to continue growing. The market's revenue is driven by the increasing demand for immunosuppressive treatments, advancements in pharmaceutical technology, and favorable market conditions.

Revenue Growth

The market is expected to grow from USD 18 billion in 2023 to USD 24.63 billion by 2031, representing a significant increase in revenue over the forecast period[1].

Cost and Pricing

The cost and pricing of MMF are influenced by several factors, including production costs, regulatory environments, and market competition. Strategic partnerships between pharmaceutical companies and healthcare institutions help in optimizing drug availability and cost, which in turn supports market expansion[1].

Research and Development

Continuous research and development are crucial for the growth of the mycophenolate mofetil market. Ongoing studies are exploring new therapeutic uses of MMF, which is expected to further expand its market potential. The development of new drug delivery methods and formulations also enhances the drug's therapeutic profile and market adoption[1][4].

Pharmacokinetics and Pharmacodynamics

Understanding the pharmacokinetics and pharmacodynamics of MMF is essential for its effective use. MMF is rapidly absorbed and metabolized to its active form, mycophenolic acid (MPA). The drug's pharmacokinetic parameters, such as bioavailability, half-life, and clearance, are well-documented and play a critical role in its clinical efficacy[2][5].

Conclusion

The market for mycophenolate mofetil hydrochloride is poised for significant growth driven by increasing organ transplants, the rising prevalence of autoimmune diseases, and advancements in pharmaceutical technology. The financial trajectory of the market is robust, with projected revenues indicating a strong and growing market.

Key Takeaways

• Market Size and Growth: The global mycophenolate mofetil market is valued at USD 18 billion in 2023 and is expected to reach USD 24.63 billion by 2031.
• Key Drivers: Increasing organ transplants, prevalence of autoimmune diseases, and advancements in formulation technology.
• Market Segmentation: By application, product form, and geographical regions.
• Competitive Landscape: Characterized by major players involved in continuous research and development.
• Financial Performance: Robust revenue growth driven by increasing demand and favorable market conditions.

FAQs

What is the primary use of mycophenolate mofetil?

Mycophenolate mofetil is primarily used as an immunosuppressive medication to prevent organ rejection in transplant patients and to treat various autoimmune diseases.

What are the key drivers of the mycophenolate mofetil market?

The key drivers include increasing global rates of organ transplants, the growing prevalence of autoimmune diseases, and advancements in pharmaceutical formulations.

How is the mycophenolate mofetil market segmented?

The market is segmented by application (e.g., pemphigus, SLE), product form (e.g., tablets, capsules), and geographical regions.

What is the expected growth rate of the mycophenolate mofetil market?

The market is expected to grow at a CAGR of 5.3% from 2024 to 2031, reaching USD 24.63 billion by 2031.

What role do advancements in pharmaceutical technology play in the market?

Advances in formulation technology, such as combination therapies and extended-release formulations, enhance the accessibility and effectiveness of MMF, contributing to market expansion.

Sources

1. Market Research Intellect: Mycophenolate Mofetil Market Size, Share, Growth Drivers, and Forecast.
2. FDA: CellCept (mycophenolate mofetil capsules) - Label.
3. PubMed: Pharmacokinetics and dynamics of mycophenolate mofetil after transplantation.
4. Market Research Intellect: Mycophenolate Mofetil (MMF) Market Size, Trends and Projections.
5. GlobalRPH: Dilution Mycophenolate - CELLCEPT®.