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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Deloitte
Farmers Insurance
Chubb
Accenture
Cipla
Teva
Fuji
Federal Trade Commission
Harvard Business School

Generated: December 15, 2017

DrugPatentWatch Database Preview

NOXAFIL Drug Profile

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When do Noxafil patents expire, and what generic alternatives are available?

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

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

The generic ingredient in NOXAFIL is posaconazole. There are fourteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the posaconazole profile page.
Drug patent expirations by year for NOXAFIL

Pharmacology for NOXAFIL

Ingredient-typeAzoles
Drug ClassAzole Antifungal

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Merck Sharp DohmeNOXAFILposaconazoleSOLUTION;IV (INFUSION)205596-001Mar 13, 2014RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
ScheringNOXAFILposaconazoleSUSPENSION;ORAL022003-001Sep 15, 2006RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Merck Sharp DohmeNOXAFILposaconazoleSOLUTION;IV (INFUSION)205596-001Mar 13, 2014RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
ScheringNOXAFILposaconazoleSUSPENSION;ORAL022003-001Sep 15, 2006RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Merck Sharp DohmeNOXAFILposaconazoleSOLUTION;IV (INFUSION)205596-001Mar 13, 2014RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Merck Sharp DohmeNOXAFILposaconazoleSOLUTION;IV (INFUSION)205596-001Mar 13, 2014RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
ScheringNOXAFILposaconazoleSUSPENSION;ORAL022003-001Sep 15, 2006RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Merck Sharp DohmeNOXAFILposaconazoleSOLUTION;IV (INFUSION)205596-001Mar 13, 2014RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Merck Sharp DohmeNOXAFILposaconazoleTABLET, DELAYED RELEASE;ORAL205053-001Nov 25, 2013RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
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Expired Patents for Tradename: NOXAFIL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp DohmeNOXAFILposaconazoleSOLUTION;IV (INFUSION)205596-001Mar 13, 2014► Subscribe► Subscribe
Merck Sharp DohmeNOXAFILposaconazoleTABLET, DELAYED RELEASE;ORAL205053-001Nov 25, 2013► Subscribe► Subscribe
ScheringNOXAFILposaconazoleSUSPENSION;ORAL022003-001Sep 15, 2006► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges 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
7,635,773Sulfoalkyl ether cyclodextrin compositions► Subscribe
5,693,626 Tetrahydrofuran antifungals► Subscribe
9,200,088Sulfoalkyl ether cyclodextrin compositions► Subscribe
9,750,822Sulfoalkyl ether cyclodextrin compositions► Subscribe
6,713,481 Crystalline antifungal polymorph► Subscribe
5,710,154 Tetrahydrofuran antifungals► Subscribe
5,714,490 Tetrahydrofuran antifungals► Subscribe
5,703,236 Tetrahydrofuran antifungals► 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 Tradename: NOXAFIL

Country Document Number Estimated Expiration
New Zealand309281► Subscribe
Norway971218► Subscribe
Japan4923144► Subscribe
Israel208956► Subscribe
China1073109► Subscribe
Norway316173► Subscribe
China1161038► Subscribe
Slovakia82696► Subscribe
Germany69628117► Subscribe
Peru09942002► 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
0736030/01Switzerland► SubscribeFORMER OWNER: SCHERING CORPORATION, US
0219Netherlands► Subscribe300219, 20141220, EXPIRES: 20191219
C0009France► SubscribePRODUCT NAME: POSACONAZOLE; REGISTRATION NO/DATE: EU/1/05/320/001 20051025
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
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
2006 00002Denmark► Subscribe
C003/2006Ireland► SubscribeSPC003/2006: 20061023, EXPIRES: 20191219
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Serving leading biopharmaceutical companies globally:

Merck
Argus Health
Farmers Insurance
Johnson and Johnson
Julphar
UBS
Fish and Richardson
Citi
McKinsey
Colorcon

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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