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Last Updated: December 22, 2024

MYCOPHENOLATE MOFETIL HYDROCHLORIDE Drug Patent Profile


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Which patents cover Mycophenolate Mofetil Hydrochloride, and what generic alternatives are available?

Mycophenolate Mofetil Hydrochloride is a drug marketed by Amneal, Bpi Labs, Endo Operations, Meitheal, Mylan Labs Ltd, Rising, Steriscience Speclts, and Zydus Pharms. and is included in eight NDAs.

The generic ingredient in MYCOPHENOLATE MOFETIL HYDROCHLORIDE 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 Mycophenolate Mofetil Hydrochloride

A generic version of MYCOPHENOLATE MOFETIL HYDROCHLORIDE was approved as mycophenolate mofetil hydrochloride by ENDO OPERATIONS on October 28th, 2016.

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Summary for MYCOPHENOLATE MOFETIL HYDROCHLORIDE
Drug patent expirations by year for MYCOPHENOLATE MOFETIL HYDROCHLORIDE
Recent Clinical Trials for MYCOPHENOLATE MOFETIL HYDROCHLORIDE

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

SponsorPhase
Fred Hutchinson Cancer CenterPhase 2
National Cord Blood NetworkPhase 2
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, ChinaPhase 1

See all MYCOPHENOLATE MOFETIL HYDROCHLORIDE clinical trials

Pharmacology for MYCOPHENOLATE MOFETIL HYDROCHLORIDE

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
Amneal MYCOPHENOLATE MOFETIL HYDROCHLORIDE mycophenolate mofetil hydrochloride INJECTABLE;INJECTION 211374-001 Mar 5, 2021 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Steriscience Speclts MYCOPHENOLATE MOFETIL HYDROCHLORIDE mycophenolate mofetil hydrochloride INJECTABLE;INJECTION 216390-001 Dec 23, 2022 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Meitheal MYCOPHENOLATE MOFETIL HYDROCHLORIDE mycophenolate mofetil hydrochloride INJECTABLE;INJECTION 212130-001 Jan 15, 2021 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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®.

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