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. Two 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
McMaster University	Phase 3
Vancouver Island Health Authority	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					Y
Cubist Pharms Llc	DIFICID	fidaxomicin	TABLET;ORAL	201699-001	May 27, 2011	AB	RX	Yes	Yes					Y
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	AB	RX	Yes	Yes					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
Slovenia	2945613
Canada	2676061
Poland	2945613
Denmark	2125850

Supplementary Protection Certificates for DIFICID

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1539977	366 50006-2015	Slovakia		OWNER(S): MERCK SHARP & DOHME LLC, RAHWAY, NJ, US; PREDCHADZAJUCI MAJITEL: MERCK SHARP & DOHME CORP., RAHWAY, NJ, US; DATUM ZAPISU DO REGISTRA: 7.10.2022
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
1539977	15C0028	France		PRODUCT NAME: FIDAXOMICINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/733/001-004 20111207

Market Dynamics and Financial Trajectory for DIFICID

Last updated: December 28, 2025

Executive Summary

DIFICID (fidaxomicin) is a macrolide antibiotic developed by Merck & Co. for the treatment of Clostridioides difficile infection (CDI). Since its FDA approval in 2011, the drug has carved a niche in the CDI market, primarily due to its efficacy and favorable safety profile compared to traditional therapies like vancomycin and metronidazole. This report explores the evolving market landscape, competitive positioning, revenue trends, regulatory factors, and forecasting insights impacting DIFICID's financial outlook through 2030.

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1. What Is DIFICID and How Does It Fit in the CDI Treatment Landscape?

Aspect	Details
Active Ingredient	Fidaxomicin (macrolide antibiotic)
Initial FDA Approval	May 2011
Indications	Approved for adults with CDI, including initial infection and recurrence
Mechanism of Action	Inhibits bacterial RNA polymerase, leading to bactericidal activity
Treatment Regimen	200 mg twice daily for 10 days

Key differentiators include:

• Reduced recurrence rates (~25%) versus vancomycin (~35-40%)
• Favorable safety profile with fewer adverse effects
• Considered first-line therapy in certain guidelines, but cost remains a barrier

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2. Market Dynamics: How Has the CDI Market Evolved?

2.1 Market Size and Growth

• Global CDI Market: Valued at approximately $1.5 billion in 2022, expected to grow at a CAGR of 4-6% through 2030
• United States Market: Largest segment, representing nearly 70% of global revenue, driven by high prevalence and Medicare/Medicaid reimbursement policies
• Key Drivers:
  • Aging population and increasing antibiotic resistance
  • Rising awareness of CDI recurrence, prompting use of fidaxomicin
  • Healthcare-associated infection (HAI) mandates

2.2 Competitive Landscape

Competitors	Products	Market Share (2022)	Differentiators
Merck	DIFICID	~50%	Efficacy, safety, recurrence reduction
Pfizer	Vancomycin (Vancocin)	~25%	Cost, long-standing use
Jensen	Bezlotoxumab (monoclonal antibody)	~10%	Recurrence prevention adjunct
Others	Metronidazole	~15%	Cost-effective, older option

Emerging therapies, including microbiome-based treatments and monoclonal antibodies, threaten to shift market share dynamics over the next decade.

2.3 Pricing and Reimbursement Trends

• Pricing: ~$2,800 per cycle in the U.S., significantly higher than vancomycin (~$150)
• Reimbursement: Covered by major insurers; Medicare Part D includes fidaxomicin, supporting stable access but limiting uptake due to cost concerns

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3. Financial Trajectory: Revenue Trends and Forecasts

3.1 Historical Revenue Performance

Year	Revenue (USD million)	Growth Rate	Notes
2011	~$60	N/A	Launch year, initial uptake slow
2015	~$250	25% YoY	Growing adoption, expanded indications
2020	~$400	10% YoY	Market stabilization, increased competition
2022	~$425	6.25% YoY	Steady, moderate growth

3.2 Factors Influencing Revenue

• Market Penetration: Limited by high cost and provider familiarity with alternatives
• Recurrence Rates: Fidaxomicin's efficacy in reducing recurrences boosts repeat prescriptions
• Regulatory Policies: NICE (UK) guidelines and CDC recommendations influence prescribing patterns
• Pricing Strategies: Merck has maintained premium pricing, balanced by reimbursement

3.3 Forecasting Key Parameters (2023-2030)

Year	Projected Revenue (USD million)	Assumptions	Notes
2025	~$600	Moderate market growth, increased adoption
2030	~$800	Market expansion, introduction of value-added formulations or new indications

Sources project a compound annual growth rate (CAGR) of approximately 4-5% during this period, contingent on the competitive landscape and healthcare policies.

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4. Regulatory & Policy Impact

4.1 Global Approvals and Indications

• FDA (U.S., 2011): Approved for adults with CDI
• EMA (Europe): Approved for CDI in adults, with ongoing evaluations for pediatric use
• Other Markets: Variable approval pathways; market entry often delayed by reimbursement hurdles

4.2 FDA and EMA Policies

• Emphasis on antibiotic stewardship and HAI reduction strategies support fidaxomicin's utilization
• Demand for cost-effectiveness data influences payer decisions
• Patent exclusivity till 2027, with potential biosimilar or generic entry thereafter

4.3 Reimbursement Policies

• CMS (Centers for Medicare & Medicaid Services): Reimburse fidaxomicin under Part D plans
• Private Insurers: Generally cover, with utilization management restrictions
• Reimbursement Challenges: High unit cost limits uptake in some institutions

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5. Competitive Positioning & Future Outlook

5.1 Strengths

• Proven efficacy in reducing recurrences
• Favorable safety profile
• Growing clinical guideline support for fidaxomicin as first-line therapy

5.2 Weaknesses

• High cost limits accessibility and adoption
• Competition from cheaper generic vancomycin and metronidazole
• Emerging treatments like fecal microbiota transplantation (FMT) and monoclonal antibodies (e.g., bezlotoxumab)

5.3 Opportunities

• Expansion into pediatric and prophylactic indications
• Development of generic versions post-patent expiry
• Strategic partnerships for broader distribution

5.4 Threats

• Biosimilar and generic entry after patent expiration
• Pricing pressures from payers and healthcare systems
• New therapies with superior efficacy or cost-effectiveness

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Comparative Analysis Table: Key Metrics (2022)

Attribute	DIFICID	Vancomycin	Metronidazole	Bezlotoxumab
Price per Treatment Cycle	~$2,800	~$150	~$20	~$15,000 (per dose)
Market Share (Estimated)	50%	25%	15%	10%
Recurrence Reduction	~25%	Baseline	Baseline	10-15% prevention
Safety Profile	Favorable	Good	Good	Good, but adjunct

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Key Drivers and Risks

Drivers	Risks
Rising CDI incidence in aging populations	Cost containment measures reducing drug reimbursement
Clinical guideline endorsements	Competitive pressure from new treatments
Reimbursement support	Patent expiry leading to biosimilar entry
Acceptance in healthcare settings	Cost sensitivity among payers

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Key Takeaways

• Market Potential: Fidaxomicin's niche position as a recurrence-reducing agent ensures steady revenue, especially in high-risk populations, with projected sales reaching ~$800 million globally by 2030.
• Revenue Sustainability: High pricing and proven efficacy sustain profitability; however, patent expiration around 2027 may challenge margins unless biosimilars or generics enter.
• Competitive Environment: Dominance is challenged by cheaper antibiotics and emerging therapies; strategic positioning and market expansion are vital.
• Regulatory Landscape: Favorable policies and clinical guidelines promote usage; ongoing evaluations may expand indications.
• Strategic Considerations: Diversification into pediatric formulations, prophylactic applications, or combination therapies could unlock additional revenue streams.

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FAQs

Q1: How does fidaxomicin compare to vancomycin in terms of efficacy?
A: Fidaxomicin demonstrates superior efficacy in reducing CDI recurrence (~25% vs. ~35-40%), with comparable initial cure rates.

Q2: What are the main barriers to wider adoption of DIFICID?
A: High cost, reimbursement restrictions, and clinician familiarity with established treatments limit broader use.

Q3: When will generic or biosimilar versions of fidaxomicin likely enter the market?
A: Patent exclusivity expires around 2027; biosimilars may appear shortly thereafter, potentially reducing prices.

Q4: Are there HPV-specific or pediatric indications for fidaxomicin?
A: Currently approved for adults; pediatric approval is under consideration depending on ongoing clinical trials.

Q5: What are the prospects for DIFICID's inclusion in international guidelines?
A: Growing evidence supports its role, with agencies like CDC and NICE recommending fidaxomicin, enhancing market prospects.

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Sources

1. FDA. (2011). FDA approves first oral antibiotic to treat Clostridium difficile infection. FDA News Release.
2. MarketWatch. (2022). Global Clostridium difficile Infection Market report.
3. CDC. (2022). Clostridioides difficile infection (CDI) statistics.
4. Merck & Co.. (2023). DIFICID product monograph.
5. IQVIA. (2022). Pharmaceutical Market Data.

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This comprehensive analysis enables pharmaceutical executives, healthcare policymakers, and investors to understand DIFICID’s current market position, ongoing challenges, and future growth opportunities.