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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Argus Health
Cipla
Federal Trade Commission
Deloitte
Healthtrust
McKesson
Teva
Julphar
UBS

Generated: January 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022484

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NDA 022484 describes ONMEL, which is a drug marketed by Sebela Ireland Ltd and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the ONMEL profile page.

The generic ingredient in ONMEL is itraconazole. There are fifteen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the itraconazole profile page.
Summary for 022484
Tradename:ONMEL
Applicant:Sebela Ireland Ltd
Ingredient:itraconazole
Patents:4
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details
Pharmacology for NDA: 022484
Medical Subject Heading (MeSH) Categories for 022484
Suppliers and Packaging for NDA: 022484
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ONMEL itraconazole TABLET;ORAL 022484 NDA Merz Pharmaceuticals, LLC 0259-1420 0259-1420-28 2 BLISTER PACK in 1 CARTON (0259-1420-28) > 14 TABLET in 1 BLISTER PACK (0259-1420-14)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Apr 29, 2010TE:RLD:Yes
Patent:➤ SubscribePatent Expiration:May 12, 2017Product Flag?YSubstance Flag?Delist Request?
Patented Use:ONYCHOMYCOSIS OF THE TOENAIL CAUSED BY TRICOPHYTON RUBRUM OR TRICHOPHYTON MENTAGROPHYTES, ONCE DAILY USE FOR 12 CONSECUTIVE WEEKS
Patent:➤ SubscribePatent Expiration:May 12, 2017Product Flag?YSubstance Flag?Delist Request?
Patented Use:ONYCHOMYCOSIS OF THE TOENAIL CAUSED BY TRICOPHYTON RUBRUM OR TRICHOPHYTON MENTAGROPHYTES, ONCE DAILY USE FOR 12 CONSECUTIVE WEEKS
Patent:➤ SubscribePatent Expiration:Oct 3, 2028Product Flag?YSubstance Flag?Delist Request?
Patented Use:ONYCHOMYCOSIS OF THE TOENAIL CAUSED BY TRICOPHYTON RUBRUM OR TRICHOPHYTON MENTAGROPHYTES, ONCE DAILY USE FOR 12 CONSECUTIVE WEEKS

Expired US Patents for NDA 022484

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sebela Ireland Ltd ONMEL itraconazole TABLET;ORAL 022484-001 Apr 29, 2010 ➤ Subscribe ➤ Subscribe
Sebela Ireland Ltd ONMEL itraconazole TABLET;ORAL 022484-001 Apr 29, 2010 ➤ Subscribe ➤ Subscribe
Sebela Ireland Ltd ONMEL itraconazole TABLET;ORAL 022484-001 Apr 29, 2010 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Express Scripts
Merck
Cerilliant
QuintilesIMS
Moodys
Chubb
McKinsey
Mallinckrodt

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 verifification 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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