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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Julphar
Citi
Cantor Fitzgerald
Farmers Insurance
US Department of Justice
UBS
Covington
Johnson and Johnson
Harvard Business School

Generated: November 23, 2017

DrugPatentWatch Database Preview

Posaconazole - Generic Drug Details

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What are the generic sources for posaconazole and what is the scope of posaconazole patent protection?

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.

Posaconazole has one hundred and thirty-four patent family members in thirty-four countries and nine supplementary protection certificates in eight countries.

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

Pharmacology for posaconazole

Ingredient-typeAzoles
Drug ClassAzole Antifungal
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck Sharp Dohme
NOXAFIL
posaconazole
TABLET, DELAYED RELEASE;ORAL205053-001Nov 25, 2013RXYesYes► Subscribe► SubscribeYY ► Subscribe
Merck Sharp Dohme
NOXAFIL
posaconazole
SOLUTION;IV (INFUSION)205596-001Mar 13, 2014RXYesYes► Subscribe► SubscribeY ► Subscribe
Merck Sharp Dohme
NOXAFIL
posaconazole
SOLUTION;IV (INFUSION)205596-001Mar 13, 2014RXYesYes► Subscribe► SubscribeY ► Subscribe
Schering
NOXAFIL
posaconazole
SUSPENSION;ORAL022003-001Sep 15, 2006RXYesYes► Subscribe► SubscribeYY ► Subscribe
Schering
NOXAFIL
posaconazole
SUSPENSION;ORAL022003-001Sep 15, 2006RXYesYes► Subscribe► SubscribeY ► Subscribe
Schering
NOXAFIL
posaconazole
SUSPENSION;ORAL022003-001Sep 15, 2006RXYesYes► Subscribe► SubscribeYY ► Subscribe
Merck Sharp Dohme
NOXAFIL
posaconazole
SOLUTION;IV (INFUSION)205596-001Mar 13, 2014RXYesYes► Subscribe► SubscribeY ► Subscribe
Merck Sharp Dohme
NOXAFIL
posaconazole
SOLUTION;IV (INFUSION)205596-001Mar 13, 2014RXYesYes► Subscribe► SubscribeY ► Subscribe
Merck Sharp Dohme
NOXAFIL
posaconazole
SOLUTION;IV (INFUSION)205596-001Mar 13, 2014RXYesYes► Subscribe► SubscribeYY ► 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, 2006► Subscribe► Subscribe
Merck Sharp Dohme
NOXAFIL
posaconazole
TABLET, DELAYED RELEASE;ORAL205053-001Nov 25, 2013► Subscribe► Subscribe
Merck Sharp Dohme
NOXAFIL
posaconazole
SOLUTION;IV (INFUSION)205596-001Mar 13, 2014► Subscribe► 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
5,693,626 Tetrahydrofuran antifungals► Subscribe
5,710,154 Tetrahydrofuran antifungals► Subscribe
5,714,490 Tetrahydrofuran antifungals► Subscribe
9,750,822Sulfoalkyl ether cyclodextrin compositions► Subscribe
7,635,773Sulfoalkyl ether cyclodextrin compositions► Subscribe
6,713,481 Crystalline antifungal polymorph► Subscribe
5,703,236 Tetrahydrofuran antifungals► Subscribe
9,200,088Sulfoalkyl ether cyclodextrin compositions► Subscribe
5,703,079 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
European Patent Office2090165► Subscribe
Japan2004527525► Subscribe
Australia2006200354► Subscribe
BrazilPI0905080► Subscribe
Japan2017019879► Subscribe
Japan2834889► Subscribe
Japan2015508846► Subscribe
Hungary9601709► Subscribe
Slovakia27097► 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
C003/2006Ireland► SubscribeSPC003/2006: 20061023, EXPIRES: 20191219
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
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
2006 00002Denmark► Subscribe
0219Netherlands► Subscribe300219, 20141220, EXPIRES: 20191219
216Luxembourg► Subscribe91216, EXPIRES: 20191220
0736030/01Switzerland► SubscribeFORMER OWNER: SCHERING CORPORATION, US
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
C0009France► SubscribePRODUCT NAME: POSACONAZOLE; REGISTRATION NO/DATE: EU/1/05/320/001 20051025
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Merck
US Army
Teva
Fuji
Daiichi Sankyo
Cantor Fitzgerald
McKinsey
Boehringer Ingelheim
Fish and Richardson
McKesson

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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