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Posaconazole - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for posaconazole?

Posaconazole is the generic ingredient in one branded drug marketed by Schering and Merck Sharp Dohme, and is included in three NDAs. There are seven patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

There are eleven drug master file entries for posaconazole. One supplier is listed for this compound.

Summary for Generic Name: posaconazole

Tradenames:1
Patents:7
Applicants:2
NDAs:3
Drug Master File Entries: see list11
Suppliers / Packagers: see list1
Bulk Api Vendors: see list50
Clinical Trials: see list29
Patent Applications: see list30
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:posaconazole at DailyMed

Pharmacology for Ingredient: posaconazole

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
Merck Sharp Dohme
NOXAFIL
posaconazole
SOLUTION;IV (INFUSION)205596-001Mar 13, 2014RXYesYes8,410,077► SubscribeY ► Subscribe
Schering
NOXAFIL
posaconazole
SUSPENSION;ORAL022003-001Sep 15, 2006RXYesYes5,661,151► SubscribeYY ► Subscribe
Merck Sharp Dohme
NOXAFIL
posaconazole
SOLUTION;IV (INFUSION)205596-001Mar 13, 2014RXYesYes9,493,582► 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, 2014RXYesYes9,023,790► SubscribeY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: posaconazole

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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Non-Orange Book Patents for Generic Ingredient: posaconazole

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
7,635,773Sulfoalkyl ether cyclodextrin compositions► Subscribe
5,703,236 Tetrahydrofuran antifungals► Subscribe
5,703,079 Tetrahydrofuran antifungals► Subscribe
5,693,626 Tetrahydrofuran antifungals► 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 Ingredient: posaconazole

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: POSACONAZOLE

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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