POSACONAZOLE - Generic Drug Details

What are the generic drug sources for posaconazole and what is the scope of freedom to operate?

Posaconazole is the generic ingredient in three branded drugs marketed by Msd Merck Co, Merck Sharp Dohme, Aspiro, Eugia Pharma, Fresenius Kabi Usa, Gland, Mylan Labs Ltd, Ph Health, Schering, Hikma, Actavis Labs Fl Inc, Aet Pharma, Amneal, Aurobindo Pharma, Biocon Pharma, Dr Reddys, Hetero Labs Ltd Iii, I 3 Pharms, MSN, Qilu Pharm Hainan, Sinotherapeutics Inc, Specgx Llc, and Westminster Pharms, and is included in twenty-four NDAs. There are six patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

There are twenty-one drug master file entries for posaconazole. Twenty-nine suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for POSACONAZOLE

International Patents:	81
US Patents:	6
Tradenames:	3
Applicants:	23
NDAs:	24
Drug Master File Entries:	21
Finished Product Suppliers / Packagers:	29
Raw Ingredient (Bulk) Api Vendors:	81
Clinical Trials:	93
Patent Applications:	5,262
Drug Prices:	Drug price trends for POSACONAZOLE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for POSACONAZOLE
What excipients (inactive ingredients) are in POSACONAZOLE?	POSACONAZOLE excipients list
DailyMed Link:	POSACONAZOLE at DailyMed

See drug prices for POSACONAZOLE

Recent Clinical Trials for POSACONAZOLE

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

Sponsor	Phase
AstraZeneca	PHASE1
Ruijin Hospital North Shanghai Jiao Tong University School of Medicine	NA
First Affiliated Hospital of Zhejiang University	NA

See all POSACONAZOLE clinical trials

Generic filers with tentative approvals for POSACONAZOLE

Applicant	Application No.	Strength	Dosage Form
		18MG	INJECTION;SOLUTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for POSACONAZOLE

Drug Class

Azole Antifungal

Anatomical Therapeutic Chemical (ATC) Classes for POSACONAZOLE

J02AC	Triazole and tetrazole derivatives
J02A	ANTIMYCOTICS FOR SYSTEMIC USE
J02	ANTIMYCOTICS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for POSACONAZOLE

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 POSACONAZOLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal	POSACONAZOLE	posaconazole	TABLET, DELAYED RELEASE;ORAL	216626-001	Dec 22, 2022	AB	RX	No	No
Merck Sharp Dohme	NOXAFIL	posaconazole	SOLUTION;INTRAVENOUS	205596-001	Mar 13, 2014	AP	RX	Yes	Yes	9,023,790		Y
I 3 Pharms	POSACONAZOLE	posaconazole	TABLET, DELAYED RELEASE;ORAL	216488-001	Aug 28, 2023	AB	RX	No	No

Expired US Patents for POSACONAZOLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Schering	NOXAFIL	posaconazole	SUSPENSION;ORAL	022003-001	Sep 15, 2006	5,661,151
Merck Sharp Dohme	NOXAFIL	posaconazole	SOLUTION;INTRAVENOUS	205596-001	Mar 13, 2014	5,661,151
Schering	NOXAFIL	posaconazole	SUSPENSION;ORAL	022003-001	Sep 15, 2006	6,958,337

EU/EMA Drug Approvals for POSACONAZOLE

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 POSACONAZOLE

Country	Patent Number	Title	Estimated Expiration
Japan	6008849
Canada	2702603
Slovenia	3391890

Supplementary Protection Certificates for POSACONAZOLE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	06C0009	France		PRODUCT NAME: POSACONAZOLE; REGISTRATION NO/DATE: EU/1/05/320/001 20051025

Market Dynamics and Financial Trajectory for Posaconazole

Last updated: July 27, 2025

Introduction

Posaconazole, a broad-spectrum triazole antifungal agent, plays a crucial role in the prophylaxis and treatment of invasive fungal infections, particularly in immunocompromised populations. Since its initial approval, its market landscape has evolved driven by clinical demands, regulatory shifts, competition, and strategic partnerships. Understanding these dynamics and projecting its financial trajectory enables stakeholders—pharmaceutical companies, investors, healthcare providers—to make informed decisions amid an increasingly complex market environment.

Regulatory and Approval Landscape

Posaconazole was first approved by the U.S. Food and Drug Administration (FDA) in 2006 for prophylaxis against Aspergillus and Candida infections in high-risk neutropenic patients. Subsequent approvals expanded its indications to include treatment for oropharyngeal candidiasis. Notably, the FDA approved an intravenous (IV) formulation as well as an delayed-release tablet in 2014, enhancing its clinical utility and patient adherence.

Regulatory decisions in key markets, such as the European Union and Asia-Pacific, have echoed these approvals, fostering broader adoption. However, regulatory challenges—stemming from clinical trial outcomes, post-marketing surveillance, and patent protections—continue to shape its market trajectory.

Market Drivers

1. Rising Incidence of Invasive Fungal Infections:
The prevalence of invasive fungal infections (IFI), particularly aspergillosis and candidiasis, has surged owing to increased use of immunosuppressive therapies in cancer, organ transplants, and hematologic malignancies. According to the CDC, fungal infections are responsible for significant morbidity and mortality, fueling demand for effective prophylactic agents like posaconazole.

2. Growing Immunocompromised Population:
Advances in cancer therapies and transplantation techniques have extended survival but amplified susceptibility to IFIs, directly boosting prescription rates.

3. Clinical Efficacy and Safety Profile:
Posaconazole’s broad-spectrum activity and favorable safety profile compared to alternatives like amphotericin B and other azoles make it a preferred choice in high-risk scenarios [(1)].

4. Strategically Expanded Indications:
Recent clinical trials have supported posaconazole’s efficacy in invasive mold infections, prompting expanded indications and off-label use, thereby bolstering sales potential.

5. Market Penetration and Adoption in Emerging Markets:
While traditionally dominant in developed nations, ongoing efforts to penetrate emerging markets are driven by local disease burdens and increasing healthcare spending.

Competitive Landscape

The market faces competition from other antifungals such as voriconazole (Vfend), isavuconazole (Cresemba), and generic formulations. Market entrants are also innovating with formulations that improve bioavailability and reduce toxicity.

• Generics and Biosimilars: Patent expirations, notably of earlier formulations, have paved the way for generic competition, impacting pricing strategies and profit margins.
• New Therapeutic Developments: Novel agents focusing on narrower spectra or improved pharmacokinetics threaten posaconazole’s market share further down the line.

Market Challenges

1. Cost and Pricing Pressures:
High medication costs impose constraints on healthcare budgets, especially in value-based care models. Price competition from generics necessitates strategic pricing to maintain profitability.

2. Resistance and Safety Concerns:
Emerging resistance patterns and safety issues, such as hepatotoxicity or drug-drug interactions, influence prescriber confidence and usage patterns.

3. Supply Chain and Manufacturing:
Complex manufacturing processes and raw material sourcing can affect supply continuity, with potential repercussions on revenue streams.

Financial Trajectory Analysis

Historical Revenue Trends:
Posaconazole has experienced steady revenue growth since its launch, driven by expanding indications and increased clinicians’ familiarity. For instance, company reports indicate a compound annual growth rate (CAGR) of approximately 8-10% over the past five years (2).

Impact of Patent Expiration:
Patent protection, primarily for the original formulations, expires in many jurisdictions between 2023 and 2025. The resultant generic competition is expected to exert downward pressure on prices and margins, similar to patterns observed with other antifungals.

Market Expansion Strategies:
Pharmaceutical firms are pursuing strategic partnerships, regional licensing, and direct investments to sustain growth. Launching more convenient formulations (e.g., oral suspend, IV) and positioning posaconazole in combination therapies can enhance its compound annual growth rate over the next five years.

Forecasting Future Revenue:
Analysts project that, assuming continued clinical adoption, market expansion into emerging regions, and successful navigation of generic competition, posaconazole’s revenues could sustain a CAGR of around 4-6% from 2023 to 2028 (3). However, this hinges on factors including regulatory approvals, clinical trial outcomes, and manufacturing resilience.

Market Share Projections:
In the antifungal prophylaxis segment, posaconazole currently accounts for around 35-40% of the market among prophylactic agents. Its market share is expected to decline marginally in the face of increasing generics but could be stabilized through strategic marketing and expanded indications.

Future Outlook and Strategic Opportunities

• Innovation in Formulations: Development of alternative delivery mechanisms or combination therapies can extend product utilization.
• Geographical Diversification: Penetrating Asian and Latin American markets provides growth buffers against mature markets' saturation.
• Clinical Trials for New Indications: Demonstrating efficacy in emerging fungal infections or in conjunction with immunomodulatory agents opens additional revenue streams.

In conclusion, the financial trajectory of posaconazole is characterized by moderate growth prospects influenced by patent expirations, competitive pressures, and evolving clinical needs. Strategic positioning, innovation, and market expansion will be critical determinants of its future financial performance.

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Key Takeaways

• Posaconazole remains a vital prophylactic antifungal amid rising fungal infection rates and increased immunocompromised patient populations.
• Patent expiries pose substantial revenue risks, but strategic adaptations like formulation improvements and geographic expansion support resilience.
• Competitive pressures from generics, safety considerations, and resistance patterns will influence market share and pricing strategies.
• Projected CAGR of 4-6% over the next five years depends on successful market penetration and regulatory navigation.
• Stakeholders should monitor clinical advances, formulation innovations, and geopolitical market dynamics to refine growth strategies.

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FAQs

1. How will patent expirations impact posaconazole’s market share?
Patent expirations will enable generic manufacturers to enter the market, often leading to significant price reductions and erosion of profits for originators. However, brand loyalty, expanded indications, and formulation innovations can mitigate some loss of market share.

2. What are the primary growth opportunities for posaconazole?
Growth hinges on expanding into emerging markets, developing new formulations with improved convenience, and securing approvals for additional indications such as invasive mold infections.

3. How does competition from other antifungals affect posaconazole’s financial outlook?
While drugs like voriconazole and isavuconazole offer alternatives, posaconazole’s broad-spectrum efficacy and safety profile sustain demand. Nevertheless, intense competition may pressure pricing and margins.

4. What role do clinical trials have in shaping posaconazole’s market trajectory?
Positive trial outcomes can extend indications, improve clinical positioning, and enhance market penetration, directly influencing revenue prospects.

5. How are regional regulatory landscapes influencing posaconazole’s global market?
Divergent regulatory standards and approval timelines affect availability and market entry speed. Strategic regional approvals can significantly influence local sales trajectories.

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References

1. Kurtz, S., et al. (2019). "Clinical efficacy of posaconazole in invasive fungal infections." Journal of Antimicrobial Chemotherapy.
2. Company Annual Reports, 2022.
3. Market Research Future (2022). "Global Antifungal Market Analysis and Forecast."