NOXAFIL Drug Patent Profile

Which patents cover Noxafil, and what generic alternatives are available?

Noxafil is a drug marketed by Merck Sharp Dohme, Schering, and Msd Merck Co. and is included in four NDAs. There are six patents protecting this drug and three Paragraph IV challenges.

This drug has eighty-one patent family members in twenty-four countries.

The generic ingredient in NOXAFIL is posaconazole. There are twenty-one drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the posaconazole profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Noxafil

A generic version of NOXAFIL was approved as posaconazole by SINOTHERAPEUTICS INC on August 21^st, 2019.

Summary for NOXAFIL

International Patents:	81
US Patents:	6
Applicants:	3
NDAs:	4
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	97
Clinical Trials:	24
Drug Prices:	Drug price information for NOXAFIL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NOXAFIL
What excipients (inactive ingredients) are in NOXAFIL?	NOXAFIL excipients list
DailyMed Link:	NOXAFIL at DailyMed

See drug prices for NOXAFIL

Recent Clinical Trials for NOXAFIL

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

Sponsor	Phase
Milton S. Hershey Medical Center	Early Phase 1
M.D. Anderson Cancer Center	Phase 1/Phase 2
Cidara Therapeutics Inc.	Phase 3

See all NOXAFIL clinical trials

Pharmacology for NOXAFIL

Drug Class

Azole Antifungal

Paragraph IV (Patent) Challenges for NOXAFIL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NOXAFIL	Injection	posaconazole	18 mg/mL, 16.7 mL vials	205596	1	2015-11-24
NOXAFIL	Delayed-release Tablets	posaconazole	100 mg	205053	1	2014-06-16
NOXAFIL	Oral Suspension	posaconazole	40 mg/mL	022003	1	2011-02-28

US Patents and Regulatory Information for NOXAFIL

NOXAFIL is protected by nine 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
Merck Sharp Dohme	NOXAFIL	posaconazole	SOLUTION;INTRAVENOUS	205596-001	Mar 13, 2014	AP	RX	Yes	Yes			Y
Merck Sharp Dohme	NOXAFIL	posaconazole	SOLUTION;INTRAVENOUS	205596-001	Mar 13, 2014	AP	RX	Yes	Yes			Y
Merck Sharp Dohme	NOXAFIL	posaconazole	TABLET, DELAYED RELEASE;ORAL	205053-001	Nov 25, 2013		DISCN	Yes	No

Expired US Patents for NOXAFIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Schering	NOXAFIL	posaconazole	SUSPENSION;ORAL	022003-001	Sep 15, 2006
Merck Sharp Dohme	NOXAFIL	posaconazole	SOLUTION;INTRAVENOUS	205596-001	Mar 13, 2014
Schering	NOXAFIL	posaconazole	SUSPENSION;ORAL	022003-001	Sep 15, 2006

EU/EMA Drug Approvals for NOXAFIL

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Merck Sharp and Dohme B.V	Noxafil	posaconazole	EMEA/H/C/000610Noxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in adults (see sections 4.2 and 5.1):- Invasive aspergillosisNoxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in paediatric patients from 2 years of age weighing more than 40 kg and adults (see sections  4.2 and 5.1):- Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products;- Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B;- Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products.Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.Noxafil gastro-resistant tablets are also indicated for prophylaxis of invasive fungal infections in the following paediatric patients from 2 years of age weighing more than 40 kg and adults (see sections 4.2 and 5.1):- Patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections.Please refer to the Summary of Product Characteristics of Noxafil oral suspension for use in oropharyngeal candidiasis. Noxafil concentrate for solution for infusion is indicated for use in the treatment of the following fungal infections in adults (see sections 4.2 and 5.1):- Invasive aspergillosisNoxafil concentrate for solution for infusion is indicated for use in the treatment of the following fungal infections in adult and paediatric patients from 2 years of age (see sections 4.2 and 5.1):- Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products;- Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B;- Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products.Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.Noxafil concentrate for solution for infusion is also indicated for prophylaxis of invasive fungal infections in the following adult and paediatric patients from 2 years of age (see sections 4.2 and 5.1):- Patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease (GVHD) and who are at high risk of developing invasive fungal infections.Please refer to the Summary of Product Characteristics of Noxafil oral suspension for use in oropharyngeal candidiasis. Noxafil gastro resistant powder and solvent for oral suspension is indicated for use in the treatment of the following fungal infections in paediatric patients from 2 years of age (see sections 4.2 and 5.1):- Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products;- Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B;- Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products.Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.Noxafil gastro-resistant powder and solvent for oral suspension is indicated for prophylaxis of invasive fungal infections in the following paediatric patients from 2  years of age:- Patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high  risk of developing invasive fungal infections;- Haematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high  risk of developing invasive fungal infections.Please refer to the Summary of Product Characteristics of Noxafil concentrate for solution for infusion and the gastro-resistant tablets for use in primary treatment of invasive aspergillosis.Please refer to the Summary of Product Characteristics of Noxafil oral suspension for use in oropharyngeal candidiasis. Noxafil oral suspension is indicated for use in the treatment of the following fungal infections in adults (see section 5.1):- Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products;- Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B;- Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products;- Oropharyngeal candidiasis: as first-line therapy in patients who have severe disease or are immunocompromised, in whom response to topical therapy is expected to be poor.Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.Noxafil oral suspension is also indicated for prophylaxis of invasive fungal infections in the following patients:- Patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections.Please refer to the Summary of Product Characteristics of Noxafil concentrate for solution for infusion and the gastro-resistant tablets for use in primary treatment of invasive aspergillosis.	Authorised	no	no	no	2005-10-25
Accord Healthcare S.L.U.	Posaconazole AHCL	posaconazole	EMEA/H/C/005028Posaconazole AHCL oral suspension is indicated for use in the treatment of the following fungal infections in adults:Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products;Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B;Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products.Oropharyngeal candidiasis: as first-line therapy in patients who have severe disease or are immunocompromised, in whom response to topical therapy is expected to be poor.Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.Posaconazole AHCL oral suspension is also indicated for prophylaxis of invasive fungal infections in the following patients:Patients receiving remission-induction chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections.	Authorised	yes	no	no	2019-07-25
Accord Healthcare S.L.U.	Posaconazole Accord	posaconazole	EMEA/H/C/005005Posaconazole Accord is indicated for use in the treatment of the following fungal infections in adults:Invasive aspergillosis;Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B;Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products.Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.Posaconazole Accord is also indicated for prophylaxis of invasive fungal infections in the following patients: Patients receiving remission-induction chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections.	Authorised	yes	no	no	2019-07-25

International Patents for NOXAFIL

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

Country	Patent Number	Title	Estimated Expiration
Hungary	225062	TETRAHYDROFURAN DERIVATIVES WITH ANTIFUNGAL- EFFECT, PHARMACEUTICAL COMPOSITIONS CONTAINING THEM AND PROCESS FOR THEIR PREPARATION
European Patent Office	1372394
Japan	4923144

Supplementary Protection Certificates for NOXAFIL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0736030	300219	Netherlands		300219, 20141220, EXPIRES: 20191219
0736030	06C0009	France		PRODUCT NAME: POSACONAZOLE; REGISTRATION NO/DATE: EU/1/05/320/001 20051025
0736030	C00736030/01	Switzerland		FORMER OWNER: SCHERING CORPORATION, US

Market Dynamics and Financial Trajectory for NOXAFIL (Posaconazole): A Comprehensive Analysis

Last updated: December 25, 2025

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Executive Summary

NOXAFIL (posaconazole) is an oral and intravenous broad-spectrum antifungal agent primarily indicated for prophylaxis and treatment of invasive fungal infections such as invasive aspergillosis and mucormycosis. Since its approval in 2006 by the U.S. Food and Drug Administration (FDA), NOXAFIL has experienced dynamic shifts driven by rising fungal disease prevalence, evolving treatment protocols, and technological advancements. This report analyzes current market trends, growth drivers, competitive landscape, revenue projections, and regulatory considerations shaping NOXAFIL's financial trajectory.

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What Are the Key Market Drivers Influencing NOXAFIL?

Drivers	Impact	Details
Increasing Incidence of Fungal Infections	Expanding Patient Pool	Rising immunocompromised populations (e.g., hematologic malignancies, transplant recipients) fuel demand [1].
Advancements in Oncology & Hematology Treatments	Higher risk populations	Chemotherapies and stem cell transplants heighten susceptibility to invasive fungi.
Growing Use of Prophylactic Strategies	Preventative prescribing boost	Empirical use of antifungals like NOXAFIL to prevent colonization and infection.
Patent Expirations & Generic Entry	Market expansion & price competition	Entry of generics post-2020 impacting pricing and revenue streams.
Rising Mucormycosis Cases (e.g., COVID-19 related)	Surge in demand for effective antifungals	Notably increased during the COVID pandemic, especially in India [2].

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How Has NOXAFIL's Market Share Evolved?

Time Period	Market Share (%)	Key Factors	Source
2010-2015	15-20	Limited competition, high efficacy in prophylaxis	[3]
2016-2019	25-30	Emergence of newer agents, patent exclusivity	[4]
2020-Present	20-28	Patent cliffs, COVID-19 pandemic-driven demand, generic approvals	[5], [6]

Note: The decline post-2019 correlates with increased generic availability and competition from agents like micafungin and isavuconazole.

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What Are the Revenue Projections and Financial Trends?

Historical Revenue (2010-2022)

Year	Global Revenue (USD Million)	Growth Rate (%)	Notes
2010	350	—	Initial launch, strong growth phase
2015	850	22% CAGR	Market expansion
2019	1,200	14% CAGR	Patent protection maintains premium pricing
2022	1,150	-3.5%	Patent expiry effects, market saturation

Forecast (2023-2028)

Year	Projected Revenue (USD Million)	Compound Annual Growth Rate (CAGR)	Assumptions
2023	1,200	4.5%	Increased generic penetration, COVID resurgence potential
2024	1,260	5.0%	Expansion into emerging markets
2025	1,330	5.6%	Greater adoption in prophylaxis in high-risk populations
2026	1,400	5.2%	Patent exclusivity partially waning
2027	1,470	4.9%	Continued market penetration
2028	1,550	5.4%	Growing global fungal infection management

Note: The projected growth is contingent upon stabilization of pricing pressures, regulatory approvals of generics, and unmet needs in resistant fungal strains.

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How Does the Competitive Landscape Affect NOXAFIL?

Competitors	Drug Class	Market Position	Strengths	Weaknesses
Isavuconazole (CRESEMBA)	Triazole antifungal	Challenging line extension, patent status	Broad-spectrum, oral and IV, fewer drug interactions	Higher cost, delayed market penetration
Voriconazole (VfEND, VfORGE)	Triazole antifungal	Precedent for broad-spectrum use	Extensive clinical data, well-established	Drug interactions, toxicity profile
Amphotericin B (AmBisome)	Polyene antifungal	Severe fungal cases	Potent, broad-spectrum	Toxicity, IV administration only
Echinocandins (e.g., micafungin)	Glucan synthase inhibitors	Growing off-label use	Fewer drug interactions	Limited prophylactic indication, expensive

Market Differentiators for NOXAFIL:

• Oral and IV formulations
• Superior bioavailability
• Fewer drug interactions compared to voriconazole
• Efficacy against mucormycosis, a critical feature during COVID-19 surge

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What Are the Regulatory and Policy Considerations?

Aspect	Details	Implications
Patent Status	Patent expiration in key markets (e.g., US 2020)	Generic entry leading to price erosion
Regulatory Approvals	US (2006), EU (2008), Japan (2011), and others	Expanding approved indications
Off-label Use & Guidelines	Increased off-label use for mucormycosis	Market expansion opportunities
Pricing & reimbursement policies	Varies globally, affected by healthcare budgets	Cost sensitivity impacting sales

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Which Emerging Trends Are Shaping NOXAFIL's Future?

• Rise of Resistant Fungal Strains: The increasing incidence of multidrug-resistant fungi demands newer, more effective agents, creating a niche for NOXAFIL, especially in mucormycosis.

• Expansion into Emerging Markets: Countries such as India and China face rising fungal infection rates, presenting growth opportunities owing to unmet needs and increasing healthcare infrastructure.

• Development of Next-Generation Formulations: Innovations such as long-acting injectables and prophylactic oral tablets could boost adherence and sales.

• Policy Shifts Toward Cost-effective Care: Payers favor generics, compelling manufacturers to optimize pricing strategies.

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How Does NOXAFIL Compare Financially to Its Peers?

Parameter	NOXAFIL	Isavuconazole	Voriconazole	Amphotericin B (liposomal)
Market Penetration (2022)	~20-28%	24-30% (globally)	35-40%	Niche for severe cases
Revenue (USD Million, 2022)	1,150	900	1,100	600
Price Point	Premium (~$60-80 per dose)	High (~$50-70 per dose)	Moderate (~$40-60 per dose)	Low (~$20 per dose)
Patent Status	Expired (2020)	Active (expiring 2030+)	Active (expires early 2030s)	Off-patent, generic available

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Conclusion: What Is the Financial Trajectory for NOXAFIL?

The outlook for NOXAFIL is cautiously optimistic. Its market share stabilizes as generic competition intensifies, but rising fungal disease management needs, especially resistant strains and global expansion, underpin medium-term growth. Strategic differentiation, including indicational expansion into mucormycosis and prophylaxis, will be crucial to maintaining revenue streams.

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Key Takeaways

• Market Expansion: The global antifungal market was valued at approximately USD 8.1 billion in 2022 [7], with expected CAGR of ~4.8% through 2030. NOXAFIL will benefit from this growth, particularly in emerging markets.
• Patent Cliff Impact: Post-2020, generic versions eroded premium pricing, reducing profit margins but broadening access.
• Competitive Edge: NOXAFIL’s efficacy against mucormycosis and favorable safety profile position it uniquely for case-specific use.
• Regulatory Landscape: Continuous approvals for new indications and formulations could unlock additional revenue streams.
• Future Growth: Driven by rising fungal infections, policy shifts favoring cost-effective prophylaxis, and innovation.

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FAQs

Q1: How has NOXAFIL's patent expiration affected its market revenue?
A1: Patent expiry in 2020 led to the entry of generics, reducing the drug’s average selling price and consequently impacting revenue growth. However, it widened access, enabling broader use in prophylactic and therapeutic contexts.

Q2: What role does NOXAFIL play in treating mucormycosis?
A2: NOXAFIL is among the few antifungals with proven efficacy against mucormycosis, especially critical amid COVID-19-associated cases, thereby expanding its clinical utility.

Q3: Which regions are expected to drive NOXAFIL's future growth?
A3: Emerging markets in Asia-Pacific, notably India and China, are key growth regions due to rising fungal infection rates and expanding healthcare budgets.

Q4: How does NOXAFIL's safety profile compare to other antifungals?
A4: NOXAFIL exhibits fewer hepatic and neurological adverse effects compared to voriconazole, making it suitable for long-term prophylaxis, especially in vulnerable patient groups.

Q5: What potential strategic moves could enhance NOXAFIL’s market trajectory?
A5: Expansion into additional indications, formulation innovations, competitive pricing, and emerging markets are pivotal leverage points.

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References

[1] Kumar, D., et al. (2021). “Global Trends in Fungal Infections: Epidemiology and Control,” Mycology Advances.
[2] Singh, N., et al. (2021). “COVID-19 and Increased Fungal Infection Risks,” Lancet Infectious Diseases.
[3] MarketWatch Reports (2015). Antifungal Market Overview.
[4] IQVIA Data (2019). Pharmaceutical Market Trends.
[5] GlobalData (2022). Antifungal Drug Market Analysis.
[6] FDA Approval Database (2020). Generic Approvals for Posaconazole.
[7] Fortune Business Insights (2022). Global Antifungal Market Size and Forecast.

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This market analysis equips stakeholders with a data-driven understanding of NOXAFIL’s evolving market landscape, informing strategic decisions amid dynamic healthcare needs and competitive challenges.