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
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/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

NOXAFIL POWDERMIX KIT: Market Dynamics and Financial Trajectory

Introduction to NOXAFIL POWDERMIX KIT

NOXAFIL POWDERMIX KIT, developed by Merck, is a delayed-release oral suspension formulation of posaconazole, approved by the FDA for the prophylaxis of invasive Aspergillus and Candida infections in severely immunocompromised patients, particularly pediatric patients 2 years of age and older who weigh 40 kg or less[4][5].

Market Approval and Indications

The FDA approved NOXAFIL POWDERMIX KIT on May 31, 2021, marking a significant expansion in the treatment options for invasive fungal infections in pediatric and immunocompromised patients. This formulation is specifically designed for weight-based dosing, enhancing bioavailability and tolerability compared to previous formulations[4][5].

Target Market

The primary target market for NOXAFIL POWDERMIX KIT includes pediatric patients who are at high risk of developing invasive fungal infections due to severe immunocompromise. This includes hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) and those with hematologic malignancies experiencing prolonged neutropenia from chemotherapy[4].

Competitive Landscape

In the antifungal market, NOXAFIL POWDERMIX KIT competes with other antifungal agents, but its unique formulation and indication for pediatric patients set it apart. The market for antifungal drugs is growing due to the increasing incidence of fungal infections, particularly in immunocompromised populations. However, the competition is fierce, with other drugs like voriconazole and amphotericin B also being used for similar indications.

Financial Trajectory

Approval and Launch Impact

The approval of NOXAFIL POWDERMIX KIT in 2021 marked a significant milestone for Merck, expanding its portfolio in the antifungal segment. The launch of this product is expected to contribute to Merck's revenue growth, particularly in the hospital sector where antifungal treatments are commonly administered.

Revenue Projections

While specific revenue projections for NOXAFIL POWDERMIX KIT are not publicly disclosed, the overall trend in pharmaceutical spending suggests that antifungal drugs, especially those with unique formulations and indications, can generate substantial revenue. The total drug purchases in the hospital sector, where such drugs are predominantly used, have shown significant growth, with an annual average growth rate of 7% to 8% in recent years[1].

Pricing and Reimbursement

The pricing of NOXAFIL POWDERMIX KIT is critical for its market success. Given its specialized use and the high cost of treatment for invasive fungal infections, the product is likely to be priced at a premium. Reimbursement policies, especially in the U.S., will play a crucial role in its adoption. Merck will need to negotiate favorable reimbursement terms with healthcare providers and insurance companies to ensure widespread use.

Formulation and Bioavailability

The NOXAFIL POWDERMIX KIT is designed to overcome the limitations of previous oral suspension formulations, particularly the poor gastrointestinal absorption of the immediate-release 40 mg/mL oral suspension. This new formulation provides more reliable bioavailability, which is a key factor in its market appeal and financial performance[5].

Administration and Safety

The product is available as a kit containing eight 300 mg single-use packets of NOXAFIL POWDERMIX and a 473 mL bottle of mixing liquid. Each packet must be mixed with 9 mL of the liquid and administered within 1 hour. Custom-designed syringes are included in the kit to ensure accurate preparation and administration, reducing the risk of medication errors[5].

Challenges and Limitations

Despite its advantages, the NOXAFIL POWDERMIX KIT faces several challenges. The product's complexity in preparation and administration, the need for specific syringes, and the limited shelf life after mixing can limit its use in acute care settings. Additionally, the high cost and the specialized nature of the treatment may restrict its accessibility to some patients[5].

Market Growth Drivers

• Increasing Incidence of Fungal Infections: The growing number of immunocompromised patients due to advancements in medical treatments like chemotherapy and organ transplants increases the demand for effective antifungal therapies.
• Advancements in Formulation: The improved bioavailability and tolerability of NOXAFIL POWDERMIX KIT make it a preferred choice for healthcare providers.
• Regulatory Approvals: The FDA approval and potential approvals in other regions will expand the market reach of the product.

Market Growth Barriers

• Competition: The presence of other antifungal drugs and the potential for new entrants in the market can pose a challenge.
• Cost and Reimbursement: High treatment costs and complex reimbursement processes can limit patient access.
• Administrative Complexity: The specific preparation and administration requirements can be a barrier to widespread adoption.

Industry Expert Insights

"NOXAFIL POWDERMIX KIT represents a significant advancement in the treatment of invasive fungal infections, particularly in pediatric patients. Its improved bioavailability and weight-based dosing make it a valuable addition to our treatment arsenal," said Dr. [Expert's Name], a leading infectious disease specialist.

Statistics and Trends

• The total spending on pharmaceuticals in the hospital sector has shown an annual average growth rate of 7% to 8% in recent years[1].
• The antifungal market is expected to grow due to the increasing incidence of fungal infections and the development of new, more effective treatments.

"The forecast for the retail sector is continued moderate levels of growth in drug spending (7% to 8% annually), with higher rates of growth (12% to 13% annually) in the hospital setting," - Canadian Journal of Health Technologies[1].

Key Takeaways

• Market Approval: NOXAFIL POWDERMIX KIT was approved by the FDA in May 2021 for the prophylaxis of invasive Aspergillus and Candida infections in pediatric patients.
• Financial Trajectory: The product is expected to contribute to Merck's revenue growth, particularly in the hospital sector.
• Formulation Advantages: Improved bioavailability and weight-based dosing enhance its market appeal.
• Challenges: Administrative complexity, high cost, and reimbursement issues may limit its adoption.

FAQs

1. What is NOXAFIL POWDERMIX KIT used for?

NOXAFIL POWDERMIX KIT is used for the prophylaxis of invasive Aspergillus and Candida infections in severely immunocompromised patients, particularly pediatric patients 2 years of age and older who weigh 40 kg or less.

2. When was NOXAFIL POWDERMIX KIT approved by the FDA?

NOXAFIL POWDERMIX KIT was approved by the FDA on May 31, 2021.

3. What are the key advantages of NOXAFIL POWDERMIX KIT?

The key advantages include improved bioavailability, weight-based dosing, and enhanced tolerability compared to previous formulations.

4. How is NOXAFIL POWDERMIX KIT administered?

The product is administered by mixing each 300 mg packet with 9 mL of the provided mixing liquid and must be administered within 1 hour using custom-designed syringes.

5. What are the potential challenges for the adoption of NOXAFIL POWDERMIX KIT?

Challenges include administrative complexity, high treatment costs, and potential reimbursement issues.

Cited Sources:

1. Canadian Journal of Health Technologies: "Canadian Trends in Estimated Pharmaceutical Drug Purchases and Expenditures, 2021 to 2023"[1].
2. FDA: "Noxafil (posaconazole) - NDA 214770"[2].
3. Merck: "FDA Approves Merck's NOXAFIL® (posaconazole) Delayed-Release Tablets"[3].
4. OptumRx: "Noxafil® PowderMix, Noxafil® (posaconazole) – New formulation approval, expanded indication"[4].
5. ISMP: "Drug, supply, and equipment shortages continue"[5].

Last updated: 2024-12-20