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 five 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. Four suppliers are listed for this compound. Additional details are available on the fidaxomicin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Dificid

A generic version of DIFICID was approved as fidaxomicin by ACTAVIS LABS FL on January 16^th, 2024.

Summary for DIFICID

International Patents:	158
US Patents:	5
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	41
Clinical Trials:	10
Patent Applications:	1,666
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 five 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	9,808,530*PED				Y
Cubist Pharms Llc	DIFICID	fidaxomicin	TABLET;ORAL	201699-001	May 27, 2011	AB	RX	Yes	Yes	7,378,508*PED				Y
Cubist Pharms Llc	DIFICID	fidaxomicin	FOR SUSPENSION;ORAL	213138-001	Jan 24, 2020		RX	Yes	Yes	7,863,249*PED				Y
Cubist Pharms Llc	DIFICID	fidaxomicin	TABLET;ORAL	201699-001	May 27, 2011	AB	RX	Yes	Yes	7,863,249*PED				Y
Cubist Pharms Llc	DIFICID	fidaxomicin	FOR SUSPENSION;ORAL	213138-001	Jan 24, 2020		RX	Yes	Yes	7,378,508*PED				Y
Cubist Pharms Llc	DIFICID	fidaxomicin	FOR SUSPENSION;ORAL	213138-001	Jan 24, 2020		RX	Yes	Yes	7,906,489*PED				Y

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/002087Dificlir 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
Mexico	340742	COMPUESTOS MACROCICLICOS DE 18 MIEMBROS Y ANALOGOS DE LOS MISMOS. (18-MEMBERED MACROCYCLES AND ANALOGS THEREOF.)
Denmark	2305244
South Korea	20090117924	MACROCYCLIC POLYMORPHS, COMPOSITIONS COMPRISING SUCH POLYMORPHS, AND METHODS OF USE AND MANUFACTURE THEREOF
World Intellectual Property Organization (WIPO)	2006085838
Canada	2676061
Japan	6101010

Supplementary Protection Certificates for DIFICID

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1539977	2015C/017	Belgium		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), MERGE
1539977	122015000026	Germany		PRODUCT NAME: FIDAXOMICIN; REGISTRATION NO/DATE: EU/1/11/733/001-004 20111205
1539977	C300727	Netherlands		PRODUCT NAME: FIDAXOMICINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/733/001-004 20111205
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	2015/019	Ireland		PRODUCT NAME: FIDAXOMICIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; NAT REGISTRATION NO/DATE: EU/1/11/733/001-004 20111205; FIRST REGISTRATION NO/DATE: EU/1/11/733/001-004 20111205
1539977	C01539977/01	Switzerland		FUSION; FORMER OWNER: MERCK SHARP AND DOHME CORP., US

Market Dynamics and Financial Trajectory for DIFICID (Fidaxomicin)

Last updated: March 5, 2026

What Is DIFICID and its Approved Indications?

DIFICID (fidaxomicin) is an oral macrocyclic antibiotic approved by the FDA in 2011 for the treatment of Clostridioides difficile infections (CDI). It is designated as a narrow-spectrum agent targeting C. difficile, reducing recurrence rates more effectively than vancomycin or metronidazole.

Key Data:

• Indication: CDI in adults.
• Brand Name: DIFICID.
• Manufacturer: Merck & Co.
• Patent Expiry: 2030 (pending patent extensions).

How Does the Market for CDI Treatments Evolve?

The CDI market is shaped by factors including infection prevalence, treatment efficacy, and resistance trends.

Infection Incidence:

• In the U.S., approximately 500,000 cases annually.
• Hospitals account for most cases; community-acquired CDI rising.
• Recurrence rate after initial treatment is 20%-25%.

Treatment Landscape:

• Vancomycin, metronidazole (prior standard).
• Fidaxomicin (DIFICID) introduced in 2011, with a niche for reducing recurrences.
• Fecal microbiota transplantation (FMT) gaining traction for recurring CDI.

Competition:

• Vancomycin and metronidazole dominate with lower costs.
• Recently approved alternatives include ridinilazole and cadazolid, but none have achieved broad market penetration.

What Are the Market Size and Revenue Trends?

Market Size:

• The CDI therapeutics market was valued at approximately USD 600 million in 2021.
• Expected to grow at a compound annual growth rate (CAGR) of 8%-10% over the next five years.

Revenue Breakdown:

Year	Estimated Global Revenue (USD million)
2022	650
2023	700
2024	770
2025	850
2026	935

Revenue Drivers:

• Increasing CDI incidence.
• Positive pricing policies for innovative antibiotics.
• Greater adoption in hospital and outpatient settings.

What Are the Factors Influencing DIFICID's Financial Trajectory?

Patent and Market Exclusivity:

• Patent protection until 2030 provides a period of market exclusivity.
• Extension strategies, including new formulation patents or approved uses.

Pricing Strategy:

• Higher per-dose cost compared to vancomycin—average wholesale price around USD 3,000 per course.
• Cost-effectiveness arguments emphasize reduction of recurrences and hospital stays.

Reimbursement Policies:

• Preferential reimbursement in established healthcare systems.
• Managed care organizations increasingly favor cost-effective CDI treatments.

Market Penetration:

• Limited by high costs, clinician familiarity, and existing guidelines.
• Merck's marketing focusing on hospital inpatient use and recurrent CDI.

Competitive Dynamics:

• Factive’s limited use due to high price.
• Variants like ridinilazole awaiting approval; potential to disrupt current market share upon approval.

What Are the Key Risks and Opportunities?

Risks:

• Patents expiring in 2030, opening the market to generics.
• Medical guidelines potentially preferring cheaper alternatives.
• Emerging resistance or microbiome-targeting therapies.

Opportunities:

• Label expansion to treat pediatric CDI.
• Development of combination therapies.
• Growth in outpatient and community-based treatment markets.

How Does This Affect Investment and R&D Strategies?

Investors should monitor patent activity, especially patent extensions or secondary indications. R&D efforts are focusing on microbiome restoration therapies and next-generation antibiotics with broader spectrum or lower costs. Licensing or acquisition of competitors or novel treatments could influence DIFICID’s market share.

Key Takeaways

• DIFICID holds a niche in CDI treatment, with a premium pricing model supported by clinical benefits.
• The global CDI treatment market is expanding, driven by rising infection rates.
• Revenue growth is constrained by high costs and competition but supported by patent protection through 2030.
• Market penetration depends on clinician adoption, reimbursement policies, and emerging alternatives.
• Patent strategies and expanding indications will determine long-term financial outcomes.

FAQs

1. When is DIFICID's patent set to expire?
In 2030, with potential extensions pending.

2. How does DIFICID compare in cost to vancomycin?
It costs approximately USD 3,000 per treatment course, compared to USD 200-500 for vancomycin.

3. What is the primary driver of DIFICID’s revenue growth?
Increased CDI incidence and preference for its recurrence-reducing efficacy.

4. Are there any regulatory or policy barriers to DIFICID’s market expansion?
None significant; however, reimbursement policies and guidelines impact market share.

5. What future developments could threaten DIFICID’s market position?
Emerging therapeutics like microbiome therapies and generics post-patent expiry.

---

References

[1] U.S. Food and Drug Administration. (2011). FDA approves Dificid for Clostridium difficile infection.
[2] MarketWatch. (2022). CDI therapeutics market size, analysis, and forecast.
[3] Pharmaceutical Journal. (2022). Antibiotic resistance trends and implications for CDI treatment.
[4] IQVIA. (2022). Global pharmaceutical market trends and forecast.
[5] FDA. (2022). Guidance on patent strategies for antibiotics.