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DIFICID Drug Patent Profile

When do Dificid patents expire, and what generic alternatives are available?

Dificid is a drug marketed by Cubist Pharms Llc and is included in two NDAs. There are six patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in DIFICID is fidaxomicin. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the fidaxomicin profile page.

DrugPatentWatch^® Generic Entry Outlook for Dificid

Dificid was eligible for patent challenges on May 27, 2015.

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for DIFICID

International Patents:	158
US Patents:	6
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	29
Clinical Trials:	10
Patent Applications:	551
Drug Prices:	Drug price information for DIFICID
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DIFICID
What excipients (inactive ingredients) are in DIFICID?	DIFICID excipients list
DailyMed Link:	DIFICID at DailyMed

See drug prices for DIFICID

Recent Clinical Trials for DIFICID

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

Sponsor	Phase
University of Alberta	Phase 2
Vancouver Island Health Authority	Phase 3
McMaster University	Phase 3

See all DIFICID clinical trials

Pharmacology for DIFICID

Drug Class

Macrolide Antibacterial

Paragraph IV (Patent) Challenges for DIFICID

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

US Patents and Regulatory Information for DIFICID

DIFICID is protected by six US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cubist Pharms Llc	DIFICID	fidaxomicin	FOR SUSPENSION;ORAL	213138-001	Jan 24, 2020		RX	Yes	Yes					Y
Cubist Pharms Llc	DIFICID	fidaxomicin	FOR SUSPENSION;ORAL	213138-001	Jan 24, 2020		RX	Yes	Yes
Cubist Pharms Llc	DIFICID	fidaxomicin	FOR SUSPENSION;ORAL	213138-001	Jan 24, 2020		RX	Yes	Yes					Y
Cubist Pharms Llc	DIFICID	fidaxomicin	TABLET;ORAL	201699-001	May 27, 2011		RX	Yes	Yes					Y
Cubist Pharms Llc	DIFICID	fidaxomicin	TABLET;ORAL	201699-001	May 27, 2011		RX	Yes	Yes

EU/EMA Drug Approvals for DIFICID

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 DIFICID

See the table below for patents covering DIFICID around the world.

Country	Patent Number	Title	Estimated Expiration
Slovenia	1539977
China	100519757
Portugal	2125850
Japan	5764168
Taiwan	200626585	18-membered macrocycles and analogs thereof

Supplementary Protection Certificates for DIFICID

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1539977	C 2015 015	Romania		PRODUCT NAME: FIDAXOMICIN; NATIONAL AUTHORISATION NUMBER: EU/1/11/733/001, EU/1/11/733/002, EU/1/11/733/003, EU/1/11/733/004; DATE OF NATIONAL AUTHORISATION: 20111205; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/11/733/001, EU/1/11/733/002, EU/1/11/733/003, EU/1/11/733/004; DATE OF FIRST AUTHORISATION IN EEA: 20111205
1539977	16/2015	Austria		PRODUCT NAME: FIDAXOMICIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/11/733/001 - 004 (MITTEILUNG) 20111207
1539977	92684	Luxembourg		PRODUCT NAME: FIDAXOMICINE OU SON SEL PHARMACEUTIQUEMENT ACCEPTABLE; AUTHORISATION NUMBER AND DATE: EU/1/11/733/001-002-004 - DIFICLIR
1539977	15C0028	France		PRODUCT NAME: FIDAXOMICINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/733/001-004 20111207
1539977	SPC/GB15/020	United Kingdom		PRODUCT NAME: FIDAXOMICIN; REGISTERED: UK EU/1/11/733/001 20111207; UK EU/1/11/733/002 20111207; UK EU/1/11/733/003 20111207; UK EU/1/11/733/004 20111207

DIFICID Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for DIFICID (Fidaxomicin)

Introduction to DIFICID

DIFICID, also known as fidaxomicin, is a macrolide antibiotic specifically designed to treat Clostridium difficile-associated diarrhea (CDAD) in adults and children 6 months of age or older. It is manufactured by Merck & Co and Astellas Pharma[3].

Mechanism of Action and Clinical Use

DIFICID works by inhibiting RNA synthesis in bacteria, which is essential for their survival and replication. This mechanism makes it effective against C. difficile, a bacterium that can cause severe gastrointestinal infections. The drug is administered orally, and its efficacy has been demonstrated in various clinical trials[3].

Market Size and Growth

The global fidaxomicin market has been experiencing steady growth. As of 2021, the market size was valued at USD 532.08 million. It is projected to reach USD 721.63 million by 2027, exhibiting a Compound Annual Growth Rate (CAGR) of 5.21%. By 2032, the market is expected to expand further to USD 930.25 million[1].

Driving Factors

Several factors are driving the growth of the fidaxomicin market:

• Growing Geriatric Population: The increasing age of the population, particularly in Europe, is a significant driver. Older adults are more susceptible to C. difficile infections, thereby increasing the demand for DIFICID[1].
• Incremental Healthcare Spending: Global healthcare spending is rising, which includes investments in treatments for infectious diseases like CDAD. This increased spending is expected to expand the market size for DIFICID[3].

Competitive Landscape

The market for DIFICID is competitive, with several key players involved:

• Astellas Pharma: One of the primary manufacturers of DIFICID.
• Merck & Co: Another major manufacturer and distributor of the drug.
• Biocon: Also involved in the production and distribution of fidaxomicin[1].

Marketed Therapies

DIFICID is one of the leading treatments for CDAD, but it faces competition from other marketed therapies. The competitive landscape includes other antibiotics and treatments that target C. difficile infections[3].

Emerging Therapies

The market is also seeing the emergence of new therapies that could potentially challenge DIFICID's dominance. These include late-stage emerging therapies that are being developed with novel approaches to treat CDAD. The launch of these therapies in the near future is expected to significantly impact the market dynamics[3].

Clinical Trials and Regulatory Milestones

DIFICID has undergone extensive clinical trials to establish its safety and efficacy. These trials have covered various aspects, including trial interventions, trial conditions, and trial status. Regulatory milestones have been crucial in the approval and continued use of DIFICID for treating CDAD[3].

Market Forecast Analysis

The market forecast for DIFICID includes detailed assessments for the seven major markets: the United States, Germany, France, Italy, Spain, the United Kingdom, and Japan. The forecasted sales data from 2025 to 2032 indicate a steady growth trajectory, driven by the increasing incidence of C. difficile infections and the expanding healthcare expenditure[3].

Financial Performance of Key Players

Merck & Co, one of the major players in the fidaxomicin market, has reported significant financial results. In 2022, Merck's worldwide sales were $13.8 billion, with a full-year revenue of $59.283 billion. While the financial performance of specific products like DIFICID is not detailed in these reports, the overall strong revenue growth of Merck indicates a favorable financial environment for its pharmaceutical products[2].

Revenue and Profitability

The financial trajectory of DIFICID is closely tied to the overall performance of its manufacturers. For instance, Merck's pharmaceutical segment, which includes DIFICID, saw a 3% increase in sales in 2023 compared to the previous year. This growth is indicative of the market's potential for DIFICID and other pharmaceutical products[5].

Challenges and Opportunities

Challenges

• Competition from Emerging Therapies: The upcoming launch of late-stage emerging therapies poses a significant challenge to DIFICID's market share.
• Regulatory Environment: Changes in regulatory requirements and milestones can impact the drug's approval and continued use.
• Economic Factors: Fluctuations in healthcare spending and economic conditions can affect the demand for DIFICID[3].

Opportunities

• Increasing Incidence of CDAD: The rising incidence of C. difficile infections presents an opportunity for DIFICID to capture a larger market share.
• Expanding Healthcare Expenditure: Incremental healthcare spending globally can lead to increased adoption of DIFICID.
• Research and Development: Continuous R&D efforts can enhance the drug's efficacy and safety, making it more competitive in the market[3].

Key Takeaways

• The global fidaxomicin market is expected to grow from USD 532.08 million in 2021 to USD 930.25 million by 2032.
• The market is driven by a growing geriatric population and increasing healthcare spending.
• DIFICID faces competition from other marketed therapies and emerging treatments.
• Clinical trials and regulatory milestones are crucial for the drug's continued approval and use.
• The financial performance of key players like Merck & Co indicates a favorable environment for DIFICID.

FAQs

What is the primary use of DIFICID?

DIFICID is used to treat Clostridium difficile-associated diarrhea (CDAD) in adults and children 6 months of age or older.

Who are the main manufacturers of DIFICID?

The main manufacturers of DIFICID are Merck & Co and Astellas Pharma.

What is the expected market size of fidaxomicin by 2032?

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

What are the driving factors for the fidaxomicin market?

The driving factors include a growing geriatric population and increasing healthcare spending.

What challenges does DIFICID face in the market?

DIFICID faces challenges from emerging therapies, regulatory changes, and economic factors.

Sources

1. Business Research Insights: Fidaxomicin Market Size - Forecast To 2032
2. Merck: Merck Announces Fourth-Quarter and Full-Year 2022 Financial Results
3. GlobeNewswire: DIFICID (Fidaxomicin) Drug Insight and Market Forecasts
4. DelveInsight: Clostridium Difficile Infections Market Size, Treatment
5. Merck: Merck Announces Fourth-Quarter and Full-Year 2023 Financial Results