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Last Updated: October 5, 2024

NOXAFIL Drug Patent Profile


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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 seventy-eight 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-eight 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 21st, 2019.

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Drug patent expirations by year for NOXAFIL
Drug Prices for NOXAFIL

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Recent Clinical Trials for NOXAFIL

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

SponsorPhase
Milton S. Hershey Medical CenterEarly Phase 1
M.D. Anderson Cancer CenterPhase 1/Phase 2
Cidara Therapeutics Inc.Phase 3

See all NOXAFIL clinical trials

Pharmacology for NOXAFIL
Drug ClassAzole 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 three FDA Regulatory Exclusivities.

Patents protecting NOXAFIL

Sulfoalkyl ether cyclodextrin compositions
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Sulfoalkyl ether cyclodextrin compositions
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Posaconazole intravenous solution formulations stabilized by substituted .beta.-cyclodextrin
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Patented Use: TREATMENT OF INVASIVE ASPERGILLOSIS IN ADULTS AND PEDIATRIC PATIENTS 13 YEARS OF AGE AND OLDER

Posaconazole intravenous solution formulations stabilized by substituted .beta.-cyclodextrin
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Patented Use: PROPHYLAXIS OF INVASIVE ASPERGILLUS AND CANDIDA INFECTIONS

Posaconazole intravenous solution formulations stabilized by substituted .beta.-cyclodextrin
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Patented Use: PROPHYLAXIS OF INVASIVE ASPERGILLUS AND CANDIDA INFECTIONS IN ADULTS AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WHO ARE SEVERELY IMMUNOCOMPROMISED

Posaconazole intravenous solution formulations stabilized by substituted .beta.-cyclodextrin
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Patented Use: TREATMENT OF INVASIVE ASPERGILLOSIS IN ADULTS AND PEDIATRIC PATIENTS 13 YEARS OF AGE AND OLDER

Posaconazole intravenous solution formulations stabilized by substituted .beta.-cyclodextrin
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Patented Use: PROPHYLAXIS OF INVASIVE ASPERGILLUS AND CANDIDA INFECTIONS IN ADULTS AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WHO ARE SEVERELY IMMUNOCOMPROMISED

Alkylated cyclodextrin compositions and processes for preparing and using the same
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Sulfoalkyl ether cyclodextrin compositions
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FDA Regulatory Exclusivity protecting NOXAFIL

NEW PATIENT POPULATION
Exclusivity Expiration: ⤷  Sign Up

FOR THE TREATMENT OF INVASIVE ASPERGILLOSIS IN ADULTS AND PEDIATRIC PATIENTS 13 YEARS OF AGE AND OLDER
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FOR THE TREATMENT OF INVASIVE ASPERGILLOSIS IN PATIENTS 13 YEARS OF AGE AND OLDER
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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 ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Merck Sharp Dohme NOXAFIL posaconazole SOLUTION;INTRAVENOUS 205596-001 Mar 13, 2014 AP RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Merck Sharp Dohme NOXAFIL posaconazole SOLUTION;INTRAVENOUS 205596-001 Mar 13, 2014 AP RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Merck Sharp Dohme NOXAFIL posaconazole SOLUTION;INTRAVENOUS 205596-001 Mar 13, 2014 AP RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for NOXAFIL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme NOXAFIL posaconazole SOLUTION;INTRAVENOUS 205596-001 Mar 13, 2014 ⤷  Sign Up ⤷  Sign Up
Schering NOXAFIL posaconazole SUSPENSION;ORAL 022003-001 Sep 15, 2006 ⤷  Sign Up ⤷  Sign Up
Schering NOXAFIL posaconazole SUSPENSION;ORAL 022003-001 Sep 15, 2006 ⤷  Sign Up ⤷  Sign Up
Schering NOXAFIL posaconazole SUSPENSION;ORAL 022003-001 Sep 15, 2006 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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/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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for NOXAFIL

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

Country Patent Number Title Estimated Expiration
Germany 69428125 ⤷  Sign Up
Argentina 002751 ANTIFUNGICOS DE TETRAHIDROFURANO, COMPOSICIONES FARMACEUTICAS QUE LOS CONTIENEN Y EL USO DE LOS COMPUESTOS PARA PREPARAR COMPOSICIONES FARMACEUTICAS UTILES PARA EL TRATAMIENTO DE INFECCIONES FUNGICAS ⤷  Sign Up
Israel 208956 תכשירי סולפואלקיל אתר ציקלודקסטרין (Sulfoalkyl ether cyclodextrin compositions) ⤷  Sign Up
Canada 2802929 FORMULATIONS D'UNE SOLUTION INTRAVEINEUSE DE POSACONAZOLE STABILISEES PAR UNE CYCLODEXTRINE BETA SUBSTITUEE (POSACONAZOLE INTRAVENOUS SOLUTION FORMULATIONS STABILIZED BY SUBSTITUTED BETA-CYCLODEXTRIN) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for NOXAFIL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0736030 8/2006 Austria ⤷  Sign Up 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
0736030 06C0009 France ⤷  Sign Up PRODUCT NAME: POSACONAZOLE; REGISTRATION NO/DATE: EU/1/05/320/001 20051025
0736030 CA 2006 00002 Denmark ⤷  Sign Up
0736030 C300219 Netherlands ⤷  Sign Up 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.