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Last Updated: December 21, 2024

MONOMETHYL FUMARATE - Generic Drug Details


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What are the generic drug sources for monomethyl fumarate and what is the scope of patent protection?

Monomethyl fumarate is the generic ingredient in one branded drug marketed by Banner Life Sciences and is included in one NDA. There are twenty-one patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Monomethyl fumarate has twenty patent family members in seven countries.

There are two drug master file entries for monomethyl fumarate. One supplier is listed for this compound.

Summary for MONOMETHYL FUMARATE
International Patents:20
US Patents:21
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 2
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 97
Clinical Trials: 10
Patent Applications: 5,215
What excipients (inactive ingredients) are in MONOMETHYL FUMARATE?MONOMETHYL FUMARATE excipients list
DailyMed Link:MONOMETHYL FUMARATE at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for MONOMETHYL FUMARATE
Generic Entry Date for MONOMETHYL FUMARATE*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE, DELAYED RELEASE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for MONOMETHYL FUMARATE

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

SponsorPhase
BiogenPhase 3
Banner Life Sciences LLCPhase 1
Almirall, S.A.Phase 1

See all MONOMETHYL FUMARATE clinical trials

US Patents and Regulatory Information for MONOMETHYL FUMARATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Banner Life Sciences BAFIERTAM monomethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 210296-001 Apr 28, 2020 RX Yes Yes 9,636,318 ⤷  Subscribe ⤷  Subscribe
Banner Life Sciences BAFIERTAM monomethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 210296-001 Apr 28, 2020 RX Yes Yes 9,566,259 ⤷  Subscribe Y ⤷  Subscribe
Banner Life Sciences BAFIERTAM monomethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 210296-001 Apr 28, 2020 RX Yes Yes 9,517,209 ⤷  Subscribe Y ⤷  Subscribe
Banner Life Sciences BAFIERTAM monomethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 210296-001 Apr 28, 2020 RX Yes Yes 10,918,616 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for MONOMETHYL FUMARATE

Country Patent Number Title Estimated Expiration
Israel 247326 קפסולות רכות למעיים של פומאראט אסטרים עם שחרור מבוקר (Controlled release enteric soft capsules of fumarate esters) ⤷  Subscribe
Denmark 3501510 ⤷  Subscribe
World Intellectual Property Organization (WIPO) 2017040272 ⤷  Subscribe
European Patent Office 3110408 ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

MONOMETHYL FUMARATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Monomethyl Fumarate

Introduction to Monomethyl Fumarate

Monomethyl fumarate (MMF), also known by its brand name Bafiertam, is a pharmaceutical compound that has garnered significant attention in recent years due to its therapeutic applications, particularly in the treatment of relapsing forms of multiple sclerosis (MS)[2].

Market Growth and Projections

The monomethyl fumarate market has experienced a rapid and substantial surge in recent years. Projections indicate a sustained and significant expansion from 2023 to 2031. This growth is driven by the increasing demand for effective treatments for MS and other conditions where MMF is applicable.

  • Market Size and Forecast: The market size of monomethyl fumarate is expected to grow significantly, with forecasts indicating robust growth rates throughout the forecast period. The market is categorized based on type (min purity less than 98%, min purity 98%-99%, min purity more than 99%) and application (broad-spectrum antibacterial, compound synthesis), as well as geographical regions[1][4].

Key Market Segments

By Type

The market is segmented based on the purity levels of monomethyl fumarate:

  • Min Purity Less Than 98%
  • Min Purity 98%-99%
  • Min Purity More Than 99% Each segment has its own market dynamics and growth prospects, with higher purity levels often commanding a premium price[1][4].

By Application

The primary applications of monomethyl fumarate include:

  • Broad-Spectrum Antibacterial: MMF is used in various antibacterial formulations.
  • Compound Synthesis: It is a crucial intermediate in the synthesis of other pharmaceutical compounds. These applications drive the demand for MMF and influence its market trajectory[1][4].

By Geography

The market is geographically segmented into:

  • North America
  • Europe
  • Asia-Pacific
  • South America
  • Middle-East and Africa Each region has its own market dynamics, regulatory environment, and consumer behavior, which affect the overall market growth[1][4].

Drivers of Market Growth

Increasing Demand for MS Treatments

The growing prevalence of multiple sclerosis and the need for effective treatments are major drivers of the MMF market. MMF, being a bioequivalent alternative to dimethyl fumarate (DMF), offers a viable treatment option for patients with relapsing forms of MS[2].

Expanding Pharmaceutical Applications

Beyond MS, MMF is used in various pharmaceutical applications, including broad-spectrum antibacterial treatments and compound synthesis. This diversification of applications contributes to the market's growth[1][4].

Regulatory Approvals

The FDA approval of MMF as a bioequivalent alternative to DMF has significantly boosted its market prospects. Regulatory approvals in other regions are also expected to drive growth[2].

Challenges and Restraints

Clinical Trials and Safety Concerns

While MMF has shown promise, there are ongoing clinical trials to fully assess its safety and efficacy. Any adverse findings could impact market growth. For instance, trials on the GI tolerability of MMF compared to DMF are crucial for its long-term acceptance[2].

Competitive Landscape

The pharmaceutical market is highly competitive, and MMF faces competition from other treatments for MS and other conditions. Established players like Biogen and emerging companies are continuously innovating, which can affect MMF's market share[3][4].

Financial Trajectory

Revenue Growth

The monomethyl fumarate market is expected to see substantial revenue growth from 2023 to 2031. The market size is projected to increase significantly, driven by the increasing demand for MMF in various applications[1][4].

Key Players and Market Share

Prominent companies such as TCI, Merck, Toronto Research Chemicals, and others are key players in the MMF market. These companies have a significant impact on the market dynamics and financial performance of the sector. The report includes detailed profiles of these companies, their market entry year, and other relevant factors[1][4].

Financial Support and Patient Access Programs

To enhance patient access and affordability, programs like Banner Patient Support offer financial assistance, including QuickStart, Bridge Support, and $0 Copay programs. These initiatives help in maintaining patient adherence to the treatment and contribute to the overall financial health of the market[5].

Economic and Political Factors

Economic Landscape

The economic landscape, including national GDP and regional economic conditions, plays a crucial role in the market's financial trajectory. Economic stability and growth in key regions can boost the demand for MMF[4].

Regulatory Environment

The regulatory environment in different countries affects the approval, pricing, and distribution of MMF. Favorable regulatory conditions can accelerate market growth, while stringent regulations can pose challenges[1][4].

Consumer Behavior and Market Penetration

Patient Awareness and Acceptance

Patient awareness and acceptance of MMF as a treatment option are critical for market growth. Educational programs and support from healthcare providers can influence consumer behavior and increase market penetration[5].

Product Penetration

The extent of product penetration at national and regional levels is another key factor. Higher penetration rates in key markets can drive revenue growth and expand the market size[4].

Conclusion

The monomethyl fumarate market is poised for significant growth driven by increasing demand for effective MS treatments, expanding pharmaceutical applications, and favorable regulatory approvals. However, the market also faces challenges such as ongoing clinical trials, competitive landscape, and regulatory hurdles.

Key Takeaways

  • Rapid Market Growth: The MMF market is experiencing rapid growth and is projected to continue this trend until 2031.
  • Diversified Applications: MMF is used in various applications, including MS treatments and compound synthesis.
  • Regulatory Approvals: FDA approval and potential approvals in other regions are crucial for market expansion.
  • Financial Support Programs: Patient support programs enhance affordability and adherence to MMF treatment.
  • Competitive Landscape: The market is competitive, with both established and emerging players influencing market dynamics.

FAQs

What is monomethyl fumarate used for?

Monomethyl fumarate (MMF) is primarily used for the treatment of relapsing forms of multiple sclerosis (MS). It is also used in broad-spectrum antibacterial treatments and compound synthesis[2].

What are the key segments of the monomethyl fumarate market?

The market is segmented by type (min purity less than 98%, min purity 98%-99%, min purity more than 99%), application (broad-spectrum antibacterial, compound synthesis), and geography (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa)[1][4].

Who are the key players in the monomethyl fumarate market?

Key players include TCI, Merck, Toronto Research Chemicals, Selleck Chemicals, and others. These companies are profiled in market reports, including their market entry year and other relevant factors[1][4].

What are the financial support programs available for patients taking monomethyl fumarate?

Financial support programs include the QuickStart Program, Bridge Support Program, and $0 Copay Program, which help patients with insurance coverage and affordability[5].

What are the challenges facing the monomethyl fumarate market?

Challenges include ongoing clinical trials, safety concerns, competitive landscape, and regulatory hurdles. These factors can impact market growth and acceptance of MMF[2][3][4].

Sources

  1. Market Research Intellect: Monomethyl Fumarate Market Size, Scope And Forecast Report
  2. VA.gov: Monomethyl fumarate (Bafiertam) - Multiple Sclerosis Centers of Excellence
  3. Biogen: BIOGEN IDEC INC. - Biogen | Investor Relations
  4. Market Research Intellect: Monomethyl Fumarate(CAS 2756-87-8) Market Size, Scope And Forecast Report
  5. Bafiertam.com: BAFIERTAM® Support and Savings

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