Fidaxomicin - Generic Drug Details

What are the generic sources for fidaxomicin and what is the scope of freedom to operate?

Fidaxomicin is the generic ingredient in two branded drugs marketed by Cubist Pharms Llc and Actavis Labs Fl, and is included in three NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Fidaxomicin has one hundred and fifty-eight patent family members in thirty-six countries.

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

Summary for fidaxomicin

International Patents:	158
US Patents:	6
Tradenames:	2
Applicants:	2
NDAs:	3
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	61
Clinical Trials:	36
Patent Applications:	1,084
Drug Prices:	Drug price trends for fidaxomicin
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for fidaxomicin
What excipients (inactive ingredients) are in fidaxomicin?	fidaxomicin excipients list
DailyMed Link:	fidaxomicin at DailyMed

See drug prices for fidaxomicin

Recent Clinical Trials for fidaxomicin

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

Sponsor	Phase
Hospital Universitario Evangelico de Curitiba	Phase 3
Hellenic Institute for the Study of Sepsis	Phase 2
Benoit Guery	Phase 3

See all fidaxomicin clinical trials

Pharmacology for fidaxomicin

Drug Class

Macrolide Antibacterial

Anatomical Therapeutic Chemical (ATC) Classes for fidaxomicin

A07AA	Antibiotics
A07A	INTESTINAL ANTIINFECTIVES
A07	ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for FIDAXOMICIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DIFICID	Tablets	fidaxomicin	200 mg	201699	1	2015-05-27

US Patents and Regulatory Information for fidaxomicin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Actavis Labs Fl	FIDAXOMICIN	fidaxomicin	TABLET;ORAL	208443-001	Jan 16, 2024		DISCN	No	No
Cubist Pharms Llc	DIFICID	fidaxomicin	TABLET;ORAL	201699-001	May 27, 2011		RX	Yes	Yes	8,859,510*PED				Y
Cubist Pharms Llc	DIFICID	fidaxomicin	FOR SUSPENSION;ORAL	213138-001	Jan 24, 2020		RX	Yes	Yes	8,586,551*PED

EU/EMA Drug Approvals for fidaxomicin

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Tillotts Pharma GmbH	Dificlir	fidaxomicin	EMEA/H/C/002087 Dificlir film-coated tablets is indicated for the treatment of Clostridioides difficile infections (CDI) also known as C. difficile-associated diarrhoea (CDAD) in adult and paediatric patients with a body weight of at least 12.5 kg.Consideration should be given to official guidelines on the appropriate use of antibacterial agents.Dificlir granules for oral suspension is indicated for the treatment of Clostridioides  difficile infections (CDI) also known as C. difficile-associated diarrhoea (CDAD) in adults and paediatric patients from birth to < 18 years of age.Consideration should be given to official guidelines on the appropriate use of antibacterial agents.	Authorised	no	no	no	2011-12-05

International Patents for fidaxomicin

Country	Patent Number	Title	Estimated Expiration
Japan	6101010
France	15C0028
Japan	5729919

Supplementary Protection Certificates for fidaxomicin

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1539977	585	Finland
1539977	1590020-2	Sweden		PRODUCT NAME: FIDAXOMICIN; TOTAL VALIDITY PERIOD: 16 JULY 2023 THROUGH 6 JUNE 2027
1539977	CR 2015 00020	Denmark		PRODUCT NAME: FIDAXOMICIN; REG. NO/DATE: EU/1/11/733/001-004 20111207

Fidaxomicin Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Fidaxomicin

Introduction

Fidaxomicin, an antibiotic specifically designed to treat Clostridium difficile infections (CDI), operates within a complex and dynamic market influenced by various factors. This article delves into the market dynamics, financial trajectory, and the challenges and opportunities associated with fidaxomicin.

Market Drivers

Several key factors drive the growth of the fidaxomicin market:

Increasing Incidence of CDI

The rising global incidence of CDI, particularly in healthcare settings, creates a significant demand for effective treatments like fidaxomicin. This antibiotic is preferred due to its targeted application and minimal disruption to normal gut flora[1].

Technological Advancements

Advancements in pharmaceutical technology enhance the efficacy and sustainability of fidaxomicin, making it a more viable treatment option. These innovations include better delivery mechanisms and combination therapies that broaden its application spectrum[1].

Expanding Healthcare Infrastructure

The expansion of healthcare infrastructure in emerging economies and the increasing healthcare expenditures worldwide open up new markets for fidaxomicin. This growth is facilitated by an increasing awareness among medical practitioners and the adoption of clinical guidelines that recommend fidaxomicin[1].

Growing Geriatric Population

The elderly population, who are more susceptible to infections, contribute to the growing demand for fidaxomicin. This demographic shift is particularly significant in regions like Europe, where the geriatric population is increasing[4].

Market Restraints

Despite the growth drivers, several challenges limit the market potential of fidaxomicin:

High Production and R&D Costs

The high costs associated with the development and production of fidaxomicin make it less affordable and accessible, especially in low-income regions. These costs can limit market penetration and growth[1].

Regulatory Hurdles

Stringent regulatory approval processes can impede the global dissemination of fidaxomicin. These regulatory barriers must be navigated carefully to ensure compliance and market access[1].

Competition from Alternative Therapies

Fidaxomicin faces competition from other antibiotics, generic drugs, and alternative therapies such as fecal microbiota transplantation (FMT) and bezlotoxumab. This competitive landscape can challenge fidaxomicin's market share[1][2].

Market Opportunities

Several opportunities exist for the fidaxomicin market:

Expansion in Developing Economies

Developing economies with expanding healthcare infrastructure offer significant growth opportunities for fidaxomicin. Increasing awareness and education among medical practitioners in these regions can drive market expansion[1].

Growing Demand in Healthcare Facilities

Healthcare facilities focused on infection control measures are increasingly demanding effective treatments like fidaxomicin. This demand is driven by the need to manage and prevent CDI effectively[1].

Collaboration and R&D Investments

Collaborations between pharmaceutical companies and research institutions, along with investments in R&D, can enhance the efficacy and resistance profiles of fidaxomicin. These efforts can lead to novel delivery mechanisms and combination therapies, further expanding the market[1].

Financial Trajectory

The financial trajectory of the fidaxomicin market is characterized by several key points:

Market Size and Growth

The global fidaxomicin market size was USD 532.08 million in 2021 and is expected to reach USD 930.25 million by 2032, exhibiting a compound annual growth rate (CAGR) of 5.21% during the forecast period[4].

Cost-Effectiveness

Despite its clinical benefits, fidaxomicin's cost-effectiveness is a significant concern. The incremental cost-effectiveness ratio for fidaxomicin is high, making it less cost-effective compared to other treatments unless its cost is significantly reduced. For instance, a course of fidaxomicin would need to cost ≤$150 to be cost-effective for all CDI cases and between $160 and $400 for non-NAP1/BI/027 strains[3].

Affordability and Insurance Coverage

The average wholesale price of fidaxomicin is approximately $5,000 per treatment course, which is a significant barrier to access. However, insurance coverage is improving, with many prescriptions covered by commercial insurance and co-payments often being less than $50[2].

Competitive Assessment

The competitive landscape of the fidaxomicin market is analyzed using Porter’s Five Forces:

Competitive Rivalry

The market is competitive with several key players such as Astellas Pharma, Merck, and Biocon. These companies compete based on market share, strategic approaches, product range, and technological advancements[1].

Bargaining Power of Buyers

Buyers, including healthcare facilities and patients, have some bargaining power due to the availability of alternative treatments and the high cost of fidaxomicin. Ensuring affordability and coverage through insurance is crucial[1].

Threat of New Entrants

New entrants into the market face significant barriers, including high R&D costs and stringent regulatory processes. However, advancements in technology and research collaborations can facilitate entry for innovative companies[1].

Product Development and Innovation

Innovation is a critical aspect of the fidaxomicin market:

Novel Delivery Mechanisms

Developing novel delivery mechanisms that enhance drug absorption and efficacy is a key area for innovation. This could include improved formulations or administration methods that make fidaxomicin more effective and user-friendly[1].

Combination Therapies

Exploring combination therapies that broaden the spectrum of fidaxomicin’s application is another area of focus. This could involve combining fidaxomicin with other antibiotics or treatments to enhance its efficacy against various strains of C. difficile[1].

Challenges During Transitions of Care

Access to fidaxomicin during transitions of care, such as hospital discharge, presents several challenges:

Affordability Barriers

Economic barriers, including high costs and insurance coverage issues, can delay or prevent patients from accessing fidaxomicin. Best practices such as determining formulary status and using manufacturer coupons can help mitigate these issues[2].

Prior Authorizations

Prior authorizations may be necessary, which can add complexity to the process of obtaining fidaxomicin. Ensuring that these authorizations are processed efficiently is crucial for timely access to the drug[2].

Key Takeaways

• The fidaxomicin market is driven by the increasing incidence of CDI, technological advancements, and expanding healthcare infrastructure.
• High production and R&D costs, regulatory hurdles, and competition from alternative therapies are significant restraints.
• The market offers opportunities for growth in developing economies and through R&D investments.
• The financial trajectory indicates a CAGR of 5.21% from 2021 to 2032, with the market expected to reach USD 930.25 million by 2032.
• Affordability and insurance coverage are critical factors influencing access to fidaxomicin.

FAQs

What is the expected market size of fidaxomicin by 2032?

The global fidaxomicin market is expected to reach USD 930.25 million by 2032[4].

What is the CAGR of the fidaxomicin market from 2021 to 2032?

The fidaxomicin market is expected to exhibit a CAGR of 5.21% from 2021 to 2032[4].

What are the main challenges facing the fidaxomicin market?

High production and R&D costs, regulatory hurdles, and competition from alternative therapies are the main challenges[1].

How does fidaxomicin compare to other treatments for CDI?

Fidaxomicin is preferentially recommended over vancomycin due to its favorable pharmacokinetic profile and reduced risk of recurrent CDI. However, its high cost makes it less cost-effective unless priced lower[3][5].

What strategies can improve access to fidaxomicin during transitions of care?

Determining formulary status, using manufacturer coupons, and ensuring efficient prior authorizations can help improve access to fidaxomicin during transitions of care[2].

Sources

1. 360iResearch: Fidaxomicin Drugs Market Size & Share 2025-2030.
2. Pharmacy Times: Access to C. difficile Treatments Presents Challenges During Transitions of Care.
3. PubMed: Is fidaxomicin worth the cost? An economic analysis.
4. Business Research Insights: Fidaxomicin Market Size - Forecast To 2032.
5. MDPI: Fidaxomicin for the Treatment of Clostridioides difficile Infection in ...