tolsura Drug Patent Profile
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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 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 |
|---|---|
| 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 |
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 | ||||
| >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 |
|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 0147492 | ⤷ Try a Trial | |
| Brazil | 112014031706 | composição farmacêutica oral; forma de composição farmacêutica oral; método de redução de efeito de alimento de itraconazol em um indivíduo; método de redução de variabilidade em um mesmo indivíduo de itraconazol; método de redução de variabilidade entre indivíduos de itraconazol; método de tratamento de onicomicose; método de tratamento de uma doença ou afecção e método de tratamento de câncer | ⤷ Try a Trial |
| Spain | 2398643 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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.
ISSN: 2162-2639
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