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NOXAFIL Drug Profile

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Which patents cover Noxafil, and what substitute generic drugs are available?

Noxafil is a drug marketed by Schering and Merck Sharp Dohme and is included in three NDAs. There are seven patents protecting this drug and three Paragraph IV challenges.

This drug has one hundred and twenty-nine patent family members in thirty-four countries.

The generic ingredient in NOXAFIL is posaconazole. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the posaconazole profile page.

Summary for Tradename: NOXAFIL

Patents:7
Applicants:2
NDAs:3
Suppliers / Packagers: see list1
Bulk Api Vendors: see list49
Clinical Trials: see list13
Patent Applications: see list30
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:NOXAFIL at DailyMed

Pharmacology for Tradename: NOXAFIL

Ingredient-typeAzoles
Drug ClassAzole Antifungal
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Schering
NOXAFIL
posaconazole
SUSPENSION;ORAL022003-001Sep 15, 2006RXYesYes5,661,151► SubscribeYY ► Subscribe
Merck Sharp Dohme
NOXAFIL
posaconazole
SOLUTION;IV (INFUSION)205596-001Mar 13, 2014RXYesYes9,358,297► SubscribeY ► Subscribe
Merck Sharp Dohme
NOXAFIL
posaconazole
TABLET, DELAYED RELEASE;ORAL205053-001Nov 25, 2013RXYesYes5,661,151► SubscribeYY ► Subscribe
Merck Sharp Dohme
NOXAFIL
posaconazole
SOLUTION;IV (INFUSION)205596-001Mar 13, 2014RXYesYes8,410,077► SubscribeY ► Subscribe
Schering
NOXAFIL
posaconazole
SUSPENSION;ORAL022003-001Sep 15, 2006RXYesYes6,958,337► SubscribeYY ► Subscribe
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Expired Patents for Tradename: NOXAFIL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Schering
NOXAFIL
posaconazole
SUSPENSION;ORAL022003-001Sep 15, 20065,703,079► Subscribe
Merck Sharp Dohme
NOXAFIL
posaconazole
SOLUTION;IV (INFUSION)205596-001Mar 13, 20145,703,079► Subscribe
Merck Sharp Dohme
NOXAFIL
posaconazole
TABLET, DELAYED RELEASE;ORAL205053-001Nov 25, 20135,703,079► Subscribe
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Paragraph IV activity for: NOXAFIL

Drugname Dosage Strength RLD Submissiondate
posaconazoleInjection18 mg/mL, 16.7 mL vialsNoxafil11/24/2015
posaconazoleDelayed-release Tablets100 mgNoxafil6/16/2014
posaconazoleOral Suspension40 mg/mLNoxafil2/28/2011

Non-Orange Book Patents for Tradename: NOXAFIL

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,200,088Sulfoalkyl ether cyclodextrin compositions► Subscribe
5,693,626 Tetrahydrofuran antifungals► Subscribe
5,714,490 Tetrahydrofuran antifungals► Subscribe
6,713,481 Crystalline antifungal polymorph► Subscribe
7,635,773Sulfoalkyl ether cyclodextrin compositions► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: NOXAFIL

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)02080678► Subscribe
Peru09942002► Subscribe
Mexico2010004900► Subscribe
South Korea0179990► Subscribe
Australia2002257104► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: NOXAFIL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2006Austria► SubscribePRODUCT NAME: POSACONAZOL, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES ODER ESTERS; REGISTRATION NO/DATE: EU/1/05/320/001 EU/1/05/321/001 20051025
216Luxembourg► Subscribe91216, EXPIRES: 20191220
00219Netherlands► SubscribePRODUCT NAME: POSACONAZOLUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ESTER EN/OF ZOUT; REGISTRATION NO/DATE: EU/1/05/320/001EU/1/05/321/001 2005251025
C003/2006Ireland► SubscribeSPC003/2006: 20061023, EXPIRES: 20191219
C/GB06/007United Kingdom► SubscribePRODUCT NAME: POSACONAZOLE, OPTIONALLY IN THE FORM OF AN ESTER OR PHARMACEUTICALLY ACCEPTABLE SALT.; REGISTERED: UK EU/1/05/320/001 20051025; UK EU/1/05/321/001 20051025
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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 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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