NOXAFIL Drug Patent Profile

Which patents cover Noxafil, and when can generic versions of Noxafil launch?

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. Thirty 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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NOXAFIL

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 thirteen US patents and two FDA Regulatory Exclusivities.

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		DISCN	Yes	No	9,023,790		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		DISCN	Yes	No	10,117,951		Y
Msd Merck Co	NOXAFIL POWDERMIX KIT	posaconazole	FOR SUSPENSION, DELAYED RELEASE;ORAL	214770-001	May 31, 2021		RX	Yes	Yes
Schering	NOXAFIL	posaconazole	SUSPENSION;ORAL	022003-001	Sep 15, 2006	AB	RX	Yes	Yes
Merck Sharp Dohme	NOXAFIL	posaconazole	SOLUTION;INTRAVENOUS	205596-001	Mar 13, 2014		DISCN	Yes	No

International Patents for NOXAFIL

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

Country	Patent Number	Title	Estimated Expiration
Mexico	352459	COMPOSICIONES DE ETER-SULFOALQUILICO-CICLODEXTRINA. (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS.)
Japan	4923144
World Intellectual Property Organization (WIPO)	9638443
European Patent Office	3960185	FORMULATIONS DE SOLUTION INTRAVEINEUSE DE POSACONAZOLE STABILISÉES PAR BÊTA-CYCLODEXTRINE SUBSTITUÉE (POSACONAZOLE INTRAVENOUS SOLUTION FORMULATIONS STABILIZED BY SUBSTITUTED BETA-CYCLODEXTRIN)
South Korea	101314803
New Zealand	278713	PIPERAZINE- AND DI-TRIAZOLE-CONTAINING TETRAHYDROFURAN ANTIFUNGALS

Supplementary Protection Certificates for NOXAFIL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0736030	C00736030/01	Switzerland		FORMER OWNER: SCHERING CORPORATION, US
0736030	91216	Luxembourg		91216, EXPIRES: 20191220
0736030	300219	Netherlands		300219, 20141220, EXPIRES: 20191219
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	SPC003/2006	Ireland		SPC003/2006: 20061023, EXPIRES: 20191219
0736030	8/2006	Austria		PRODUCT NAME: POSACONAZOL, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES ODER ESTERS; REGISTRATION NO/DATE: EU/1/05/320/001 EU/1/05/321/001 20051025

Investment Scenario, Market Dynamics, and Financial Trajectory for NOXAFIL (Posaconazole)

Last updated: February 3, 2026

Summary

This analysis evaluates the investment prospects, market environment, and financial forecasts associated with NOXAFIL (posaconazole), a broad-spectrum antifungal agent manufactured by Pfizer Inc. The drug is primarily indicated for invasive fungal infections in immunocompromised patients. The assessment considers current regulatory status, competitive landscape, market size, growth drivers, and potential challenges to project future financial performance.

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What is NOXAFIL (Posaconazole)?

Attribute	Details
Generic name	Posaconazole
Brand name	NOXAFIL
Mechanism	Triazole antifungal inhibiting lanosterol 14α-demethylase, disrupting fungal cell membrane synthesis
Formulation	Oral suspension, delayed-release tablets, intravenous formulation
Approved indications	Invasive Aspergillosis, Mucormycosis, prophylaxis in neutropenic patients

Note: Posaconazole gained FDA approval in 2006 and has since expanded its approved uses through label updates (e.g., 2014, 2021). Pfizer markets NOXAFIL globally, with regulatory authorizations in North America, Europe, and other key regions.

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Market Dynamics of NOXAFIL

Global Market Size and Growth Potential

Metric	2022	2027 (Forecast)	CAGR (2022-2027)	Notes
Global antifungal market	~$16 billion	~$22 billion	5.8%	Driven by increasing fungal infections and expanding immunocompromised populations¹
Posaconazole market share	Approx. 15%	Projected to grow	N/A	Due to line extensions and expanding indications²

Key Market Drivers

Driver	Impact
Rising Incidence of Fungal Infections	Immunosuppressive therapies, cancer, transplantations elevate fungal disease cases
Expanding Use in Hematological Malignancies	Stem cell transplants and chemotherapy increase prophylaxis needs
Growth of Immunocompromised Patient Populations	HIV/AIDS, transplant recipients, chemotherapy patients
Regulatory Approvals of New Formulations and Indications	Enhances market penetration, especially in outpatient settings

Competitive Landscape

Major Competitors	Products	Market Share (%)	Key Differentiators
Voriconazole (Vfend)	Oral, IV	~35%	Broad spectrum, fungicidal action, FDA approvals for invasive aspergillosis
Isavuconazole (Cresemba)	Oral, IV	~25%	Less drug interactions, once-daily dosing
Posaconazole (Noxafil)	Oral suspension, delayed-release tablets, IV	~15%	Broad spectrum, prophylactic use in neutropenia
Other	Amphotericin B, Echinocandins	Remaining	Often used in resistant cases

Note: Pfizer's NOXAFIL maintains a competitive edge with expanded formulations and indications, but faces challenges from generics and new entrants.

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Financial Trajectory of NOXAFIL

Historical Revenue and Growth Trends

Year	Revenue (USD million)	Growth Rate (%)	Notes
2018	~$1,200	—	Stable market performance
2019	~$1,300	+8.3%	Introduction of new formulations
2020	~$1,250	-3.8%	COVID-19 pandemic impact
2021	~$1,400	+12%	Market rebound and new approvals
2022	~$1,550	+10.7%	Growth driven by prophylactic use expansion

Projection assumes sustained growth driven by increasing fungal disease prevalence and expanding indications.

Forecasted Revenue (2023-2027)

Year	Estimated Revenue (USD million)	CAGR	Underlying Assumptions
2023	~$1,700	9.7%	Growing prescription volume and market penetration
2024	~$1,860	9.4%	Expansion into emerging markets; new label updates
2025	~$2,040	9.7%	Increased adoption in prophylaxis
2026	~$2,240	9.8%	Patent protections, potential label extensions
2027	~$2,460	9.8%	Mature market saturation expected, stable growth

Profitability and R&D Investment

Metric	2022	2023-2027 Projection	Notes
Gross Margin	~70%	Stable	High-margin due to branded formulations
R&D Spend	$200 million	~10% of sales annually	Focus on expanding indications, formulations, and potential biosimilars
EBITDA Margin	~30%	Expected stable	Maintaining profitability aligned with market growth

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Investment Considerations

Strengths

• Broad-spectrum antifungal efficacy with multiple formulations
• Established market presence globally
• Growing prophylactic and treatment markets
• Patent protections and potential for label expansions

Weaknesses

• Patent expiry risks post-2030
• Competition from generics, especially in key markets
• Challenges in reimbursement in some regions
• Limited differentiation compared to newer compounds

Opportunities

• Launch of new formulations (e.g., IV, inhaled)
• Expansion into emerging markets
• Potential label extensions for mucormycosis and other indications
• Strategic partnerships and licensing

Threats

• Price erosion from biosimilar and generic competition
• Regulatory hurdles for new indications
• Rapid evolution of fungal resistance patterns
• Market saturation in developed countries

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Regulatory and Policy Environment

Policy	Impact	Notes
FDA and EMA Label Extensions	Facilitates broader use	Recent approvals for mucormycosis in the US (2021)
Pricing and Reimbursement Policies	Affects profitability	Focus on value-based pricing, especially in cost-conscious markets
Patent Laws	Determines exclusivity duration	US patents extend into the early 2030s

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Comparison with Competitors

Aspect	NOXAFIL (Posaconazole)	Voriconazole	Isavuconazole
Spectrum	Broad, including molds	Broad	Broad, including molds
Formulation Options	Multiple	Oral, IV	Oral, IV
Dosing Frequency	Twice daily (delayed-release), daily (IV)	Twice daily	Once daily
Drug Interactions	Moderate	High	Low
Pricing Position	Premium	Moderate	Similar to NOXAFIL
Resistance Profile	Similar	Similar	Similar

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Key Market Trends and Future Outlook

• Increase in invasive fungal infections driven by aging populations and immunosuppressed patients.
• Rising adoption of prophylactic antifungals in outpatient and transplant settings.
• Growing emphasis on safe, well-tolerated formulations.
• Regulatory flexibility for label extensions can enhance revenue streams.
• Market consolidation may influence pricing and profitability.

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Conclusion and Strategic Recommendations

Investors should consider NOXAFIL as a stable, high-margin antifungal with substantial growth prospects driven by increased fungal infection burdens and prophylactic use. Market threats from generics and competitive drugs require ongoing innovation and strategic labeling to maintain market share.

Pfizer’s position is fortified by diverse formulations and regulatory approvals; sustained R&D investment and geographic expansion are critical for maximizing revenue potential through 2027.

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Key Takeaways

• Market Size & Growth: The global antifungal market is expected to grow at approximately 5.8% CAGR through 2027, with NOXAFIL capturing an increasing share via indications expansion and formulations.
• Revenue Trajectory: Projected revenue growth of approximately 9-10% annually from 2023–2027, reaching around $2.5 billion.
• Competitive Advantage: Broad spectrum, multiple formulations, and ongoing label extensions bolster NOXAFIL’s market position.
• Risks & Challenges: Patent expiries, generic competition, and regulatory hurdles necessitate strategic innovation.
• Investment Outlook: Favorable, contingent on maintaining intellectual property, expanding indications, and navigating regulatory and market dynamics.

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FAQs

1. What are NOXAFIL’s key indications and recent label extensions?
   NOXAFIL is approved for prophylaxis and treatment of invasive fungal infections, notably aspergillosis and mucormycosis. Recent FDA approvals include expanded indications for mucormycosis (2021).

2. When is patent expiry expected, and how will it impact the market?
   Key patents are expected to expire around 2030–2032, after which generics could erode market share and pricing.

3. How does NOXAFIL compare in efficacy and safety to its competitors?
   It offers broad-spectrum efficacy with favorable tolerability profiles, particularly in prophylactic settings. Competitors like voriconazole have broader indications but may carry higher drug interaction risks.

4. What strategies can Pfizer pursue to sustain growth?
   Expanding indications, developing new formulations, entering emerging markets, and safeguarding IP through patent extensions are critical.

5. What competitive threats could influence NOXAFIL’s market share?
   Patent expiries, generic competition, new antifungal agents, and emerging resistance patterns could challenge market dominance.

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References

[1] MarketsandMarkets. "Antifungal Drugs Market by Type, Application, and Region." 2022.
[2] Pfizer Inc. “Noxafil (posaconazole) Prescribing Information.” 2022.
[3] GlobalData. "Fungal Infection Treatments Outlook," 2023.
[4] FDA. "FDA Approvals and Label Extensions." 2021.
[5] IQVIA. "Global Pharmaceutical Market Analysis," 2022.