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 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 28th, 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 |
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 |
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
US Patents and Regulatory Information for TOLSURA
TOLSURA is protected by five US patents.
Patents protecting TOLSURA
Itraconazole compositions and dosage forms, and methods of using the same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF FUNGAL INFECTIONS, INCLUDING BLASTOMYCOSIS, HISTOPLASMOSIS, AND ASPERGILLOSIS
Itraconazole compositions and dosage forms, and methods of using the same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Itraconazole compositions and dosage forms, and methods of using the same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Itraconazole compositions and dosage forms, and methods of using the same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Itraconazole compositions and dosage forms, and methods of using the same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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 | TOLSURA | itraconazole | CAPSULE;ORAL | 208901-001 | Dec 11, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Mayne Pharma | TOLSURA | itraconazole | CAPSULE;ORAL | 208901-001 | Dec 11, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Mayne Pharma | TOLSURA | itraconazole | CAPSULE;ORAL | 208901-001 | Dec 11, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Mayne Pharma | TOLSURA | itraconazole | CAPSULE;ORAL | 208901-001 | Dec 11, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
>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 TOLSURA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Mayne Pharma | TOLSURA | itraconazole | CAPSULE;ORAL | 208901-001 | Dec 11, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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 |
---|---|---|---|
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) | ⤷ Try a Trial |
Mexico | 2015000179 | 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.) | ⤷ Try a Trial |
South Korea | 20210043721 | 이트라코나졸 조성물 및 투여형, 그리고 이것들의 사용 방법 (ITRACONAZOLE COMPOSITIONS AND DOSAGE FORMS AND METHODS OF USING THE SAME) | ⤷ Try a Trial |
Canada | 2396380 | COMPOSITIONS PHARMACEUTIQUES AMELIOREES POUR MEDICAMENTS PEU SOLUBLES (IMPROVED PHARMACEUTICAL COMPOSITIONS FOR POORLY SOLUBLE DRUGS) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |