TOLSURA Drug Patent Profile
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.
The generic ingredient in TOLSURA is itraconazole. There is one drug master file entry for this compound. Fourteen 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.
AI Deep Research
Questions you can ask:
- What is the 5 year forecast for TOLSURA?
- What are the global sales for TOLSURA?
- What is Average Wholesale Price for TOLSURA?
Summary for TOLSURA
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 84 |
| Clinical Trials: | 1 |
| Patent Applications: | 5,726 |
| 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 |
|---|---|
| George R Thompson | Phase 2 |
| Mayne Pharma International Pty Ltd | Phase 2 |
Pharmacology for TOLSURA
| Drug Class | Azole Antifungal |
| Mechanism of Action | Breast Cancer Resistance Protein Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors |
US Patents and Regulatory Information for TOLSURA
TOLSURA is protected by five US patents.
| 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 | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Mayne Pharma | TOLSURA | itraconazole | CAPSULE;ORAL | 208901-001 | Dec 11, 2018 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Mayne Pharma | TOLSURA | itraconazole | CAPSULE;ORAL | 208901-001 | Dec 11, 2018 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Mayne Pharma | TOLSURA | itraconazole | CAPSULE;ORAL | 208901-001 | Dec 11, 2018 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Mayne Pharma | TOLSURA | itraconazole | CAPSULE;ORAL | 208901-001 | Dec 11, 2018 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start 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 | ⤷ Start Trial | ⤷ Start 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/002722For 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 |
|---|---|---|---|
| Australia | 2013278001 | ⤷ Start Trial | |
| Australia | 2018201298 | ⤷ Start Trial | |
| Australia | 2020217438 | ⤷ Start Trial | |
| Brazil | 112014031706 | ⤷ Start Trial | |
| Canada | 2876909 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
DrugChatter Q&A for TOLSURA
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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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.
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