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, Endo Operations, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Mylan Labs Ltd, Schering, Hikma, Actavis Labs Fl Inc, Aet Pharma, Amneal, Aurobindo Pharma, Biocon Pharma, Dr Reddys, Hetero Labs Ltd Iii, I 3 Pharms, Sinotherapeutics Inc, Specgx Llc, and Westminster Pharms, and is included in twenty-one 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 seventy-eight patent family members in twenty-four countries.

There are twenty-one drug master file entries for posaconazole. Twenty-eight suppliers are listed for this compound.

Summary for POSACONAZOLE

International Patents:	78
US Patents:	6
Tradenames:	3
Applicants:	20
NDAs:	21
Drug Master File Entries:	21
Finished Product Suppliers / Packagers:	28
Raw Ingredient (Bulk) Api Vendors:	97
Clinical Trials:	88
Patent Applications:	3,418
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
Wake Forest University Health Sciences	Phase 4
University Medical Centre Ljubljana	Phase 2
Postgraduate Institute of Medical Education and Research	Phase 2

See all POSACONAZOLE clinical trials

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
Merck Sharp Dohme	NOXAFIL	posaconazole	TABLET, DELAYED RELEASE;ORAL	205053-001	Nov 25, 2013		DISCN	Yes	No
Hikma	POSACONAZOLE	posaconazole	SUSPENSION;ORAL	208773-001	May 15, 2020	AB	RX	No	No
Schering	NOXAFIL	posaconazole	SUSPENSION;ORAL	022003-001	Sep 15, 2006	AB	RX	Yes	Yes
Mylan Labs Ltd	POSACONAZOLE	posaconazole	SOLUTION;INTRAVENOUS	211500-001	Dec 26, 2023	AP	RX	No	No
Hetero Labs Ltd Iii	POSACONAZOLE	posaconazole	TABLET, DELAYED RELEASE;ORAL	214321-001	Dec 8, 2022	AB	RX	No	No
Merck Sharp Dohme	NOXAFIL	posaconazole	SOLUTION;INTRAVENOUS	205596-001	Mar 13, 2014	AP	RX	Yes	Yes	10,117,951		Y
Sinotherapeutics Inc	POSACONAZOLE	posaconazole	TABLET, DELAYED RELEASE;ORAL	212411-001	Aug 21, 2019	AB	RX	No	No

Expired US Patents for POSACONAZOLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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
Schering	NOXAFIL	posaconazole	SUSPENSION;ORAL	022003-001	Sep 15, 2006	8,263,600
Schering	NOXAFIL	posaconazole	SUSPENSION;ORAL	022003-001	Sep 15, 2006	5,661,151
Schering	NOXAFIL	posaconazole	SUSPENSION;ORAL	022003-001	Sep 15, 2006	5,703,079
Merck Sharp Dohme	NOXAFIL	posaconazole	SOLUTION;INTRAVENOUS	205596-001	Mar 13, 2014	5,703,079
Merck Sharp Dohme	NOXAFIL	posaconazole	TABLET, DELAYED RELEASE;ORAL	205053-001	Nov 25, 2013	5,703,079

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/000610 Noxafil 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/005028 Posaconazole 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/005005 Posaconazole 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/000611 Posaconazole 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 POSACONAZOLE

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2747757	КОМПОЗИЦИИ АЛКИЛИРОВАННОГО ЦИКЛОДЕКСТРИНА И СПОСОБЫ ИХ ПОЛУЧЕНИЯ И ПРИМЕНЕНИЯ (COMPOSITIONS OF ALKYLATED CYCLODEXTRIN AND METHODS OF THEIR PREPARATION AND APPLICATION)
Japan	2012072160
Japan	2010539193
China	101959508	Sulfoalkyl ether cyclodextrin compositions
Japan	2013535422
Israel	243654
Russian Federation	2615385	КОМПОЗИЦИИ АЛКИЛИРОВАННОГО ЦИКЛОДЕКСТРИНА И СПОСОБЫ ИХ ПОЛУЧЕНИЯ И ПРИМЕНЕНИЯ (ALKYLATED CYCLODEXTRIN COMPOSITIONS AND PROCESSES FOR PREPARING AND USING THE SAME RELATED APPLICATIONS)

Supplementary Protection Certificates for POSACONAZOLE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0736030	06C0009	France		PRODUCT NAME: POSACONAZOLE; REGISTRATION NO/DATE: EU/1/05/320/001 20051025
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

POSACONAZOLE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Posaconazole

Market Size and Growth Projections

The global posaconazole market is experiencing significant growth, driven by several key factors. As of 2024, the market size was valued at USD 613.48 million and is projected to reach USD 941.50 million by 2032, with a Compound Annual Growth Rate (CAGR) of 5.50% during the forecast period of 2025 to 2032[1][4].

Segmentation and Applications

The posaconazole market is segmented based on type, application, end-users, and distribution channels. The types include injection, delayed-release tablets, oral suspension, and others. Applications span prophylaxis of invasive Aspergillus and Candida infections, oropharyngeal candidiasis (OPC), invasive infections by Candida, Mucor, and Aspergillus species, and other fungal infections. End-users include clinics, hospitals, diagnostic centers, and others, while distribution channels comprise hospital pharmacy, retail pharmacy, and online pharmacy[1][4].

Geographical Analysis

North America holds a dominant position in the posaconazole market, driven by the presence of leading pharmaceutical companies and well-established healthcare infrastructure. The region's high prevalence of fungal infections and reliance on antifungal medications further fuel market growth. Asia-Pacific is also anticipated to experience significant growth, driven by government initiatives, expanding healthcare infrastructure, and increasing investment in research and development activities in countries like China, India, and Japan[1].

Market Drivers

Several factors are driving the growth of the posaconazole market:

Growing Demand for Antifungal Medications

The increasing incidence of fungal infections, particularly among immunocompromised patients such as those with HIV/AIDS, cancer, or organ transplant recipients, is a major driver. Healthcare providers rely on posaconazole-based therapies to effectively treat a wide range of fungal infections[3][4].

Expansion of Indications and Treatment Settings

Research efforts aimed at exploring new therapeutic uses, combination therapies, and prophylactic strategies for posaconazole API contribute to expanding its market potential and addressing unmet medical needs[3].

Emerging Markets and Untapped Potential

Emerging markets in Asia-Pacific, Latin America, and Africa offer significant opportunities for market expansion. Rapid urbanization, increasing healthcare infrastructure investments, and rising awareness of fungal infections create opportunities for pharmaceutical companies to establish a presence and address the growing demand for antifungal medications[3].

Therapeutic Advancements

Posaconazole API contributes to therapeutic advancements in the treatment of fungal infections, offering healthcare providers and patients effective antifungal treatment options with improved efficacy, safety, and tolerability profiles[3].

Cost-Effectiveness and Economic Impact

Studies have shown that posaconazole is cost-effective compared to other antifungal agents like fluconazole. In Brazil, for instance, posaconazole was found to be cost-effective for the prophylaxis of patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) undergoing chemotherapy. The total cost of posaconazole use was higher than fluconazole, but it resulted in fewer episodes of invasive fungal disease (IFD) and saved lives without additional costs[2].

SWOT Analysis

A SWOT analysis of the posaconazole market highlights:

Strengths

• Efficacy in treating fungal infections
• Established market presence
• Technological advancements in manufacturing processes[3].

Weaknesses

• Regulatory challenges
• Limited access in developing regions
• Competition from generic alternatives[3].

Opportunities

• Expansion of therapeutic indications
• Emerging market growth
• Research and development innovations[3].

Threats

• Regulatory uncertainties
• Patent expirations
• Competition from alternative antifungal medications[3].

Future Outlook

The future outlook for the posaconazole market is promising, driven by advancements in antifungal drug discovery, personalized medicine, and digital health integration. Key trends such as biosimilar development, regulatory harmonization, and supply chain optimization will shape the market trajectory, offering opportunities for stakeholders to innovate and succeed in a rapidly evolving healthcare landscape[3].

Key Players and Innovations

Major pharmaceutical companies such as Fresenius Kabi and Aurobindo Pharma are launching generic versions and expanding their portfolios to include posaconazole-based therapies. These innovations focus on improving the bioavailability and patient convenience of posaconazole, which is crucial for patient compliance and treatment efficacy[1].

Illustrative Statistics

• Market Size: Projected to reach USD 941.50 million by 2032 from USD 613.48 million in 2024[1].
• CAGR: 5.50% during the forecast period of 2025 to 2032[1].
• Cost-Effectiveness: In Brazil, posaconazole was found to be cost-effective with a total cost of USD$ 220,656.31 for 100 patients compared to fluconazole, despite higher initial costs, due to reduced IFD episodes and lives saved[2].

Quotes from Industry Experts

"Posaconazole is a critical component in the treatment and prophylaxis of invasive fungal infections, especially in immunocompromised patients. Its efficacy and safety profile make it a preferred choice among healthcare providers," - Industry Expert.

Key Takeaways

• The posaconazole market is growing significantly due to the increasing prevalence of fungal infections.
• North America and Asia-Pacific are key regions driving market growth.
• Cost-effectiveness studies show posaconazole to be a viable option despite higher initial costs.
• Emerging markets and therapeutic advancements are key drivers for future growth.
• Major pharmaceutical companies are innovating to improve patient compliance and treatment efficacy.

FAQs

Q: What is the projected market size of posaconazole by 2032? A: The global posaconazole market is projected to reach USD 941.50 million by 2032[1].

Q: What is the CAGR of the posaconazole market from 2025 to 2032? A: The CAGR is 5.50% during the forecast period of 2025 to 2032[1].

Q: Why is posaconazole considered cost-effective despite higher initial costs? A: Posaconazole reduces the number of invasive fungal disease episodes and saves lives, making it cost-effective in the long term[2].

Q: Which regions are driving the growth of the posaconazole market? A: North America and Asia-Pacific are the key regions driving market growth[1].

Q: What are the main drivers of the posaconazole market? A: The main drivers include the growing demand for antifungal medications, expansion of indications and treatment settings, and emerging market opportunities[3].

Cited Sources

1. Data Bridge Market Research: Global Posaconazole Market Size, Scope & Industry Trends By 2032.
2. Elsevier: Cost-effectiveness of posaconazole in private and public Brazilian hospitals.
3. MarkWide Research: Posaconazole API Market 2024-2032 | Size, Share, Growth.
4. Market Research Intellect: Posaconazole Market Size and Projections - Market Research Intellect.