ONMEL Drug Patent Profile
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Which patents cover Onmel, and what generic alternatives are available?
Onmel is a drug marketed by Sebela Ireland Ltd and is included in one NDA. There is one patent protecting this drug.
This drug has eight patent family members in five countries.
The generic ingredient in ONMEL is itraconazole. There are fifteen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the itraconazole profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Onmel
A generic version of ONMEL was approved as itraconazole by SANDOZ on May 28th, 2004.
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Summary for ONMEL
| International Patents: | 8 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 84 |
| Patent Applications: | 4,161 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ONMEL |
| DailyMed Link: | ONMEL at DailyMed |
US Patents and Regulatory Information for ONMEL
ONMEL is protected by one US patents.
Patents protecting ONMEL
Itraconazole compositions with improved bioavailability
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: ONYCHOMYCOSIS OF THE TOENAIL CAUSED BY TRICOPHYTON RUBRUM OR TRICHOPHYTON MENTAGROPHYTES, ONCE DAILY USE FOR 12 CONSECUTIVE WEEKS
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sebela Ireland Ltd | ONMEL | itraconazole | TABLET;ORAL | 022484-001 | Apr 29, 2010 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >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 ONMEL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sebela Ireland Ltd | ONMEL | itraconazole | TABLET;ORAL | 022484-001 | Apr 29, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| Sebela Ireland Ltd | ONMEL | itraconazole | TABLET;ORAL | 022484-001 | Apr 29, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| Sebela Ireland Ltd | ONMEL | itraconazole | TABLET;ORAL | 022484-001 | Apr 29, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for ONMEL
| 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 ONMEL
See the table below for patents covering ONMEL around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| China | 1165291 | ⤷ Sign Up | |
| Japan | 3391801 | ⤷ Sign Up | |
| Spain | 2212810 | ⤷ Sign Up | |
| New Zealand | 330739 | PARTICULATE SOLID DISPERSION OF ITRACONAZOLE AND A WATER SOLUBLE POLYMER | ⤷ Sign Up |
| Japan | 2009504589 | ⤷ Sign Up | |
| Portugal | 904060 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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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. 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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