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 seventy-seven patent family members in twenty-three countries.

The generic ingredient in NOXAFIL is posaconazole. There are twenty-one drug master file entries for this compound. Twenty-one 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:	77
US Patents:	6
Applicants:	3
NDAs:	4
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	96
Clinical Trials:	24
Patent Applications:	2,127
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for NOXAFIL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NOXAFIL
What excipients (inactive ingredients) are in NOXAFIL?	NOXAFIL excipients list
DailyMed Link:	NOXAFIL at DailyMed

See drug prices for NOXAFIL

Recent Clinical Trials for NOXAFIL

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

Sponsor	Phase
Milton S. Hershey Medical Center	Early Phase 1
M.D. Anderson Cancer Center	Phase 1/Phase 2
Cidara Therapeutics Inc.	Phase 3

See all NOXAFIL clinical trials

Pharmacology for NOXAFIL

Drug Class

Azole Antifungal

Anatomical Therapeutic Chemical (ATC) Classes for NOXAFIL

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 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

FDA Regulatory Exclusivity protecting NOXAFIL

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			Y
Merck Sharp Dohme	NOXAFIL	posaconazole	SOLUTION;INTRAVENOUS	205596-001	Mar 13, 2014	AP	RX	Yes	Yes			Y
Merck Sharp Dohme	NOXAFIL	posaconazole	SOLUTION;INTRAVENOUS	205596-001	Mar 13, 2014	AP	RX	Yes	Yes

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
Schering	NOXAFIL	posaconazole	SUSPENSION;ORAL	022003-001	Sep 15, 2006
Merck Sharp Dohme	NOXAFIL	posaconazole	TABLET, DELAYED RELEASE;ORAL	205053-001	Nov 25, 2013

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

International Patents for NOXAFIL

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

Country	Patent Number	Title	Estimated Expiration
Mexico	PA03009021	COMPOSICION ANTIFUNGAL CON BIODISPONIBILIDAD AUMENTADA. (ANTIFUNGAL COMPOSITION WITH ENHANCED BIOAVAILABILITY.)
European Patent Office	0736030	TETRAHYDROFURANES ANTIFONGIQUES (TETRAHYDROFURAN ANTIFUNGALS)
Slovakia	283035

Supplementary Protection Certificates for NOXAFIL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0736030	C300219	Netherlands		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
0736030	SPC003/2006	Ireland		SPC003/2006: 20061023, EXPIRES: 20191219
0736030	C00736030/01	Switzerland		FORMER OWNER: SCHERING CORPORATION, US