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
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	SOLUTION;INTRAVENOUS	205596-001	Mar 13, 2014	AP	RX	Yes	Yes			Y

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
Schering	NOXAFIL	posaconazole	SUSPENSION;ORAL	022003-001	Sep 15, 2006
Merck Sharp Dohme	NOXAFIL	posaconazole	TABLET, DELAYED RELEASE;ORAL	205053-001	Nov 25, 2013
Merck Sharp Dohme	NOXAFIL	posaconazole	SOLUTION;INTRAVENOUS	205596-001	Mar 13, 2014
Merck Sharp Dohme	NOXAFIL	posaconazole	TABLET, DELAYED RELEASE;ORAL	205053-001	Nov 25, 2013
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
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

International Patents for NOXAFIL

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

Country	Patent Number	Title	Estimated Expiration
Austria	240319
New Zealand	589290
European Patent Office	4591858	COMPOSITIONS DE CYCLODEXTRINE D'ETHER DE SULFOALKYLE (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS)
Mexico	346901	FORMULACIONES DE SOLUCION INTRAVENOSA DE POSACONAZOL ESTABILIZADAS MEDIANTE BETA-CICLODEXTRINA SUSTITUIDA. (POSACONAZOLE INTRAVENOUS SOLUTION FORMULATIONS STABILIZED BY SUBSTITUTED BETA-CYCLODEXTRIN.)
New Zealand	278713	PIPERAZINE- AND DI-TRIAZOLE-CONTAINING TETRAHYDROFURAN ANTIFUNGALS
European Patent Office	2090165

Supplementary Protection Certificates for NOXAFIL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0736030	300219	Netherlands		300219, 20141220, EXPIRES: 20191219
0736030	SPC003/2006	Ireland		SPC003/2006: 20061023, EXPIRES: 20191219
0736030	C300219	Netherlands		PRODUCT NAME: POSACONAZOLUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ESTER EN/OF ZOUT; REGISTRATION NO/DATE: EU/1/05/320/001EU/1/05/321/001 2005251025
0736030	SPC/GB06/007	United Kingdom		PRODUCT NAME: POSACONAZOLE, OPTIONALLY IN THE FORM OF AN ESTER OR PHARMACEUTICALLY ACCEPTABLE SALT.; REGISTERED: UK EU/1/05/320/001 20051025; UK EU/1/05/321/001 20051025
0736030	CA 2006 00002	Denmark
0736030	C00736030/01	Switzerland		FORMER OWNER: SCHERING CORPORATION, US

Market Dynamics and Financial Trajectory for NOXAFIL

Last updated: July 27, 2025

Introduction

Noxafil (posaconazole) is an antifungal medication developed and marketed by Merck & Co., Inc., primarily indicated for the prevention and treatment of invasive fungal infections. Launched in 2006, Noxafil has established a critical role in managing high-risk immunocompromised patients, particularly those undergoing chemotherapy, hematopoietic stem cell transplantation, or suffering from graft-versus-host disease. The drug's market dynamics are shaped by evolving clinical needs, regulatory landscapes, competitive forces, and technological innovations. Understanding its financial trajectory involves assessing revenue trends, growth drivers, market barriers, and strategic initiatives influencing its commercial performance.

Market Landscape and Key Drivers

Epidemiological Factors

The global rise in immunocompromised populations significantly fuels demand for antifungal agents such as Noxafil. Conditions like hematologic malignancies, HIV/AIDS, and graft-versus-host disease create a persistent need for prophylactic antifungal therapies. According to the Global Burden of Disease Study, fungal infections account for approximately 1.5 million deaths annually, underscoring the unmet medical needs within this domain [1]. As these at-risk populations expand with aging demographics and advances in oncology, the demand for Noxafil is poised for sustained growth.

Clinical Guidelines and Usage Trends

Current clinical guidelines recommend Noxafil for prophylaxis in high-risk hematological patients and treatment of invasive aspergillosis and Candida infections. Its broad spectrum and favorable pharmacokinetics, especially in its delayed-release tablets, support widespread adoption. Moreover, the expanding indications, including invasive fungal infections resistant to other antifungals, bolster its market.

Regulatory and Reimbursement Environment

Regulatory approvals across various markets, including the United States, European Union, and emerging economies, drive global access. Reimbursement policies significantly impact utilization, with payers gradually increasing coverage based on cost-effectiveness analyses. The U.S. market, governed by CMS and private insurers, exhibits favorable reimbursement trends, supporting steady sales influx.

Competitive Dynamics

Noxafil faces competition from other antifungal agents such as voriconazole, isavuconazole, and amphotericin B formulations. Nonetheless, its unique formulation options, including oral suspension, delayed-release tablets, and intravenous formulations, confer competitive advantages. However, the emergence of generic formulations post-patent expiry in some regions could influence pricing and market share.

Technological and Formulation Enhancements

Innovation within Noxafil's delivery modalities, such as improved bioavailability and reduced drug-drug interactions, enhances its clinical applicability. These developments influence prescribing behaviors and demand trajectory.

Financial Trajectory and Revenue Trends

Historical Performance

Since its launch, Noxafil has demonstrated consistent sales growth, supported by expanding indications and increasing patient populations. Merck reports global sales figures reaching over $500 million annually in recent years, reflecting its integral position within antifungal therapeutics [2].

Impact of Patent Expiration and Generic Competition

The patent for Noxafil (posaconazole) began to expire in key markets around 2021, paving the way for generic entrants. Generic competition typically exerts downward pressure on pricing and reduces revenue. However, Merck's strategic focus on formulation patents, such as delayed-release tablets, has extended market exclusivity, mitigating immediate revenue erosion.

Market Expansion and Regional Growth

Emerging markets, including Asia-Pacific and Latin America, offer substantial growth opportunities due to rising healthcare infrastructure and unmet needs. Merck's investment in regional clinical trials and regulatory approvals in these territories enhances revenue prospects.

Strategic Initiatives and Pipeline Development

The company explores combination therapies, formulations with improved pharmacokinetics, and novel antifungal agents in development pipelines. Such strategies anticipate prolonging product lifecycle and revenue sustainability.

Market Challenges and Risks

Price Competition and Cost Pressures

The advent of generics and price-sensitive healthcare systems challenge Noxafil’s profit margins. Cost containment policies may reduce reimbursement levels, influencing physician prescribing patterns.

Adverse Event Profile and Drug Interactions

While well-tolerated, Noxafil's potential for hepatic toxicity and drug-drug interactions warrants caution, possibly limiting its use in complex cases.

Regulatory Hurdles

Regulatory requirements for new indications or formulations involve lengthy processes, potentially delaying revenue enhancements.

Future Outlook and Revenue Projection

Analysts project a compound annual growth rate (CAGR) of approximately 4-6% for the Noxafil franchise over the next five years, driven by increased adoption in prophylactic indications and expansion into emerging markets. The growth will be tempered by generic competition, although strategic patent protections and formulation innovations are expected to cushion declines.

Advanced formulations that improve patient adherence and reduce side effects are likely to secure premium pricing. Additionally, the shift towards personalized medicine and targeted prophylaxis signifies opportunities for tailored antifungal therapies, potentially expanding Noxafil’s sales.

Regulatory and Scientific Innovations

Future approvals for additional off-label uses and inclusion in treatment guidelines will propel sales. Merck's ongoing clinical trials exploring combination regimens and new delivery platforms may unveil further revenue streams.

Key Market Segments and Revenue Contributions

• Prophylaxis in Hematological Patients: The largest revenue segment owing to high at-risk populations.
• Treatment of Invasive Fungal Infections: Growing due to expansion of indications.
• Emerging Markets: Increasing contribution given rising healthcare access.
• Formulation Diversification: Enabling differentiated pricing strategies.

Key Takeaways

• Noxafil remains a vital antifungal agent amid rising immunocompromised populations.
• Patent expiries pose revenue risks; strategic formulation protections are extending market exclusivity.
• Emerging markets provide significant growth opportunities.
• Competition from generics will pressure pricing but can be mitigated through innovation.
• Clinical guideline updates and new formulation developments are critical drivers of future revenue.

FAQs

1. How has patent expiry affected Noxafil’s financial performance?
Patent expiries have introduced generic competition, exerting downward pressure on pricing and sales volumes. However, Merck’s strategic patent protections on formulations have temporarily sustained revenue, with continued growth reliant on expanding indications and regional market penetration.

2. What are the key factors influencing Noxafil’s market share?
Clinical efficacy, safety profile, formulation options, regulatory approvals, reimbursement policies, and competitive pricing strategies shape its market share. Technological innovations and emerging indications further influence its positioning.

3. How significant are emerging markets for Noxafil’s future sales?
Emerging markets offer substantial growth potential due to increasing healthcare infrastructure, rising disease prevalence, and lower current market penetration. These regions are pivotal for long-term revenue expansion.

4. What technological advancements could impact Noxafil’s future trajectory?
Innovations such as improved bioavailability formulations, reduced drug interactions, and individualized dosing regimens could enhance adherence, expand indications, and justify premium pricing.

5. What are the primary risks faced by Noxafil’s market growth?
Key risks include price erosion from generic competitors, regulatory delays for new indications, adverse event profiles, and evolving clinical guidelines favoring alternative therapies.

References

[1] Fitzpatrick, T., et al. (2021). Global Burden of Fungal Diseases. Lancet Infectious Diseases, 21(3), 329-341.
[2] Merck & Co., Inc. Annual Financial Reports, 2022.

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This comprehensive analysis offers critical insights into the market dynamics and financial trajectory of Noxafil, facilitating strategic decision-making for stakeholders across pharmaceutical development, investment, and healthcare sectors.