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Last Updated: September 25, 2022

TOLSURA Drug Patent Profile


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When do Tolsura patents expire, and what generic alternatives are available?

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

This drug has thirty patent family members in twelve countries.

The generic ingredient in TOLSURA is itraconazole. There are fifteen drug master file entries for this compound. Twenty-one 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 28th, 2004.

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Summary for TOLSURA
International Patents:30
US Patents:6
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Clinical Trials: 1
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
Drug patent expirations by year for TOLSURA
Drug Prices for TOLSURA

See drug prices for TOLSURA

Recent Clinical Trials for TOLSURA

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

SponsorPhase
George R ThompsonPhase 2
Mayne Pharma International Pty LtdPhase 2

See all TOLSURA clinical trials

US Patents and Regulatory Information for TOLSURA

TOLSURA is protected by six US patents.

Patents protecting TOLSURA

Itraconazole compositions and dosage forms, and methods of using the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF FUNGAL INFECTIONS, INCLUDING BLASTOMYCOSIS, HISTOPLASMOSIS, AND ASPERGILLOSIS

Itraconazole compositions and dosage forms, and methods of using the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pharmaceutical compositions for poorly soluble drugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Itraconazole compositions and dosage forms, and methods of using the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Itraconazole compositions and dosage forms, and methods of using the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Itraconazole compositions and dosage forms, and methods of using the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF FUNGAL INFECTIONS, INCLUDING BLASTOMYCOSIS, HISTOPLASMOSIS, AND ASPERGILLOSIS

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

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

International Patents for TOLSURA

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

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 0147492 See Plans and Pricing
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) See Plans and Pricing
Australia 2020217438 Itraconazole compositions and dosage forms, and methods of using the same See Plans and Pricing
Canada 2396380 COMPOSITIONS PHARMACEUTIQUES AMELIOREES POUR MEDICAMENTS PEU SOLUBLES (IMPROVED PHARMACEUTICAL COMPOSITIONS FOR POORLY SOLUBLE DRUGS) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Medtronic
Express Scripts
Johnson and Johnson
Mallinckrodt
McKinsey
McKesson

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.