NOXAFIL POWDERMIX KIT Drug Patent Profile

When do Noxafil Powdermix Kit patents expire, and when can generic versions of Noxafil Powdermix Kit launch?

Noxafil Powdermix Kit is a drug marketed by Msd Merck Co and is included in one NDA.

The generic ingredient in NOXAFIL POWDERMIX KIT 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 Powdermix Kit

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

Summary for NOXAFIL POWDERMIX KIT

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	2,791
DailyMed Link:	NOXAFIL POWDERMIX KIT at DailyMed

Pharmacology for NOXAFIL POWDERMIX KIT

Drug Class

Azole Antifungal

US Patents and Regulatory Information for NOXAFIL POWDERMIX KIT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Msd Merck Co	NOXAFIL POWDERMIX KIT	posaconazole	FOR SUSPENSION, DELAYED RELEASE;ORAL	214770-001	May 31, 2021		RX	Yes	Yes

EU/EMA Drug Approvals for NOXAFIL POWDERMIX KIT

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
Schering-Plough Europe	Posaconazole SP	posaconazole	EMEA/H/C/000611Posaconazole SP 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.Posaconazole SP 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 areat 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.	Withdrawn	no	no	no	2005-10-25

Market Dynamics and Financial Trajectory for NOXAFIL POWDERMIX KIT

Last updated: July 30, 2025

Introduction

NOXAFIL POWDERMIX KIT, a formulation of posaconazole, is a pivotal antifungal agent designed primarily for prophylaxis and treatment of invasive fungal infections, especially in immunocompromised patients such as those undergoing hematopoietic stem cell transplants or chemotherapy for leukemia. Its unique formulation as a powder for oral suspension offers advantages over traditional intravenous delivery, facilitating outpatient management. This analysis explores the current market landscape, underlying driver forces, competitive environment, regulatory considerations, and future financial prospects of NOXAFIL POWDERMIX KIT within the broader antifungal therapeutics segment.

Market Overview

The global antifungal drugs market is projected to reach USD 11.2 billion by 2030, expanding at a CAGR of approximately 4.7% from 2022 to 2030 [1]. The rising prevalence of invasive fungal infections, especially among immunocompromised populations, sustains demand. The antifungal segment includes azoles, polyenes, echinocandins, and others; posaconazole, the active component of NOXAFIL, belongs to broad-spectrum triazoles.

North America dominates the market due to high healthcare spending, advanced medical infrastructure, and the prevalence of hematological malignancies. Europe and Asia-Pacific follow, with Asia-Pacific experiencing rapid growth attributed to increasing healthcare access and rising awareness regarding fungal infections.

Market Drivers

1. Growing Incidence of Invasive Fungal Infections

Immunosuppression from chemotherapy, organ transplantation, and HIV/AIDS elevates susceptibility to invasive candidiasis, aspergillosis, and other rare fungi. According to the CDC, invasive fungal infections compromise approximately 1.2 million patients annually in the U.S. alone [2], fueling demand for effective prophylactic agents like NOXAFIL.

2. Shift Toward Outpatient Therapy

The powdered formulation facilitates easier administration, especially in outpatient settings, reducing hospitalization costs. The convenience enhances patient compliance, prompting healthcare providers to prefer oral formulations over intravenous alternatives.

3. Rising Cancer Burden

Cancer incidence, particularly hematologic malignancies requiring aggressive immunosuppressive therapy, correlates with increased fungal infection risk. The International Agency for Research on Cancer reports over 19 million new cancer cases worldwide annually, underpinning sustained antifungal demand [3].

4. Advances in Formulation Technologies

The development of powder formulations and suspensions extend the drug’s usability, particularly for pediatric and severely ill patients unable to swallow pills. Innovating delivery modalities enhances market penetration.

5. Regulatory Approvals and Reimbursement Trends

Extensive clinical trials supporting NOXAFIL's efficacy and safety have facilitated regulatory approvals in major markets. Reimbursement development, especially in developed economies, improves access and usage.

Competitive Landscape

Major Players

• MSD (Merck & Co.): Manufacturer of Noxafil (posaconazole) tablets, an oral tablet alternative.
• Fresenius Kabi: Offers a generic version of posaconazole powder.
• Other Generics: Emerging biotech firms focusing on biosimilars and formulations.

Differentiators

The PowderMIX Kit’s advantage lies in its clinical flexibility, stability, and convenience. However, competition from newer formulations (e.g., tablet-based posaconazole) and emerging bioequivalent generics alters the dynamic landscape, emphasizing cost competitiveness.

Market Share Dynamics

While branded formulations retain a significant share in the U.S. and Europe, generics are rapidly gaining in emerging markets due to lower prices. Market penetration for NOXAFIL POWDERMIX KIT hinges on strategic pricing, physician preference, and patient compliance.

Regulatory and Reimbursement Environment

FDA and EMA Approvals

The PowderMIX Kit has achieved approval based on data demonstrating similar bioavailability to existing formulations. Ongoing post-marketing surveillance mitigates regulatory risks.

Insurance Coverage and Cost-Effectiveness

Access to reimbursement significantly influences utilization. Cost-effectiveness analyses position NOXAFIL as an essential prophylactic agent. However, price sensitivity persists in lower-income regions, affecting volume growth.

Financial Trajectory and Forecasts

Revenue Streams

The primary revenue driver remains direct sales of the PowderMIX Kit, with additional income from regional licensing and partnerships. The product’s lifecycle profitability depends on patent statuses, generic competition, and clinical demand.

Growth Projections

Considering compound annual growth rates, the antifungal segment anticipated to grow at approximately 4.7% through 2030 suggests a steady increase in NOXAFIL POWDERMIX Kit sales. The expanding patient base, especially with rising cancer incidence and immunosuppressed populations, underpins this trajectory.

Moreover, geographic expansion into emerging markets, where antifungal awareness is increasing, could accelerate overall revenue growth. Price concessions aligned with healthcare affordability in these regions may temper margins but expand market share significantly.

Risks and Challenges

• Patent Expirations: When key patents expire, generic competition could suppress prices.
• Emerging Therapies: Novel antifungal agents with improved efficacy or safety profiles could replace existing formulations.
• Regulatory Hurdles: Discrepancies in approval requirements across regions may delay or limit market entry.
• Pricing Pressures: Increased competition and reimbursement constraints could reduce profit margins.

Opportunities for Growth

• Line Extension: Developing new formulations, such as pediatric excipients or combination therapies.
• Strategic Partnerships: Co-marketing with healthcare providers and payers to expand accessibility.
• Clinical Trials and Label Expansion: Demonstrating efficacy for additional indications broadens therapeutic application and revenue scope.

Conclusion

The NOXAFIL POWDERMIX KIT occupies a vital niche within the antifungal market, driven by increasing fungal infection prevalence, formulary advantages, and technological innovations. The product’s financial outlook remains optimistic, conditioned on competitive management, patent strategies, and expanding regional access. As disease burdens persist and formulations evolve, NOXAFIL’s market position hinges on balancing innovation, cost management, and regulatory agility.

Key Takeaways

• Strong Demand Drivers: Rising immunocompromised populations and outpatient therapy preferences sustain demand for NOXAFIL POWDERMIX KIT.
• Competitive Environment: The market faces intensifying generic competition, necessitating strategic pricing and differentiation.
• Regulatory and Reimbursement Factors: Successful navigation of approvals and payer policies underpin revenue stability.
• Growth Opportunities: Geographic expansion and formulation innovation present avenues to amplify market share.
• Risk Management: Vigilance on patent expiry, emerging competitors, and price pressures is essential for sustained financial performance.

FAQs

1. How does NOXAFIL POWDERMIX KIT compare to other antifungal formulations?
The PowderMIX Kit offers the convenience of oral suspension, facilitating outpatient management and pediatric use. While tablets are available, powders provide flexibility in administration and stability advantages, enhancing patient compliance.

2. What are the key regulatory considerations for NOXAFIL POWDERMIX KIT?
Regulatory approvals rely on demonstrating bioequivalence to existing formulations, safety profiles, and manufacturing quality. Variations across regions mandate tailored approval strategies.

3. How does patent expiration impact the financial outlook of NOXAFIL?
Patent expirations invite generic competition, typically leading to price erosion and revenue decline unless offset by line extensions or new indications.

4. What competitive advantages does NOXAFIL POWDERMIX KIT offer to healthcare providers?
Its ease of administration, stability, and suitability for outpatient care make it a preferred choice for prophylaxis in immunocompromised patients.

5. What emerging trends could influence NOXAFIL’s market trajectory?
Development of novel antifungal agents, advances in personalized medicine, and healthcare reforms promoting outpatient treatment will shape future demand and competition.

---

Sources:
[1] Grand View Research. "Antifungal Drugs Market Size, Share & Trends Analysis Report," 2022.
[2] CDC. "Fungal Infections," 2021.
[3] IARC. "Global Cancer Statistics," 2020.