TOLSURA Drug Patent Profile

Which patents cover Tolsura, and what generic alternatives are available?

Tolsura is a drug marketed by Mayne Pharma and is included in one NDA. There are five patents protecting this drug.

This drug has eighteen patent family members in ten countries.

The generic ingredient in TOLSURA is itraconazole. There are fifteen drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the itraconazole profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Tolsura

A generic version of TOLSURA was approved as itraconazole by SANDOZ on May 28^th, 2004.

Summary for TOLSURA

International Patents:	18
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	84
Clinical Trials:	1
Patent Applications:	4,077
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for TOLSURA
What excipients (inactive ingredients) are in TOLSURA?	TOLSURA excipients list
DailyMed Link:	TOLSURA at DailyMed

See drug prices for TOLSURA

Recent Clinical Trials for TOLSURA

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

Sponsor	Phase
Mayne Pharma International Pty Ltd	Phase 2
George R Thompson	Phase 2

See all TOLSURA clinical trials

Pharmacology for TOLSURA

Drug Class	Azole Antifungal
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for TOLSURA

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

US Patents and Regulatory Information for TOLSURA

TOLSURA is protected by five US patents.

Patents protecting TOLSURA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mayne Pharma	TOLSURA	itraconazole	CAPSULE;ORAL	208901-001	Dec 11, 2018		RX	Yes	Yes			Y
Mayne Pharma	TOLSURA	itraconazole	CAPSULE;ORAL	208901-001	Dec 11, 2018		RX	Yes	Yes			Y
Mayne Pharma	TOLSURA	itraconazole	CAPSULE;ORAL	208901-001	Dec 11, 2018		RX	Yes	Yes
Mayne Pharma	TOLSURA	itraconazole	CAPSULE;ORAL	208901-001	Dec 11, 2018		RX	Yes	Yes			Y
Mayne Pharma	TOLSURA	itraconazole	CAPSULE;ORAL	208901-001	Dec 11, 2018		RX	Yes	Yes			Y

Expired US Patents for TOLSURA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mayne Pharma	TOLSURA	itraconazole	CAPSULE;ORAL	208901-001	Dec 11, 2018

EU/EMA Drug Approvals for TOLSURA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Avimedical B.V.	Fungitraxx	itraconazole	EMEA/V/C/002722 For the treatment of aspergillosis and candidiasis in companion birds,	Authorised	no	no	no	2014-03-12

International Patents for TOLSURA

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

Country	Patent Number	Title	Estimated Expiration
Mexico	366829	COMPOSICIONES Y FORMAS DE DOSIFICACION DE ITRACONAZOL Y METODOS DE USO DE LAS MISMAS. (ITRACONAZOLE COMPOSITIONS AND DOSAGE FORMS, AND METHODS OF USING THE SAME.)
European Patent Office	2863911	COMPOSITIONS ET FORMES GALÉNIQUES D'ITRACONAZOLE ET LEURS PROCÉDÉS D'UTILISATION (ITRACONAZOLE COMPOSITIONS AND DOSAGE FORMS, AND METHODS OF USING THE SAME)
Japan	2018162304	イトラコナゾール組成物及び投与剤形、並びにその使用方法 (ITRACONAZOLE COMPOSITIONS AND DOSAGE FORMS, AND METHODS OF USING THE SAME)
China	104507480	Itraconazole compositions and dosage forms, and methods of using the same
Japan	2015531749	イトラコナゾール組成物及び投与剤形、並びにその使用方法
European Patent Office	1239831	COMPOSITIONS PHARMACEUTIQUES AMELIOREES POUR MEDICAMENTS PEU SOLUBLES (IMPROVED PHARMACEUTICAL COMPOSITIONS FOR POORLY SOLUBLE DRUGS)
China	109674795	伊曲康唑组合物和剂型及其使用方法 (Itraconazole compositions and dosage forms, and methods of using the same)