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Last Updated: January 24, 2021

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NOXAFIL Drug Profile

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Which patents cover Noxafil, and when can generic versions of Noxafil launch?

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 eighty-nine patent family members in twenty-one countries.

The generic ingredient in NOXAFIL is posaconazole. There are twenty-one drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the posaconazole profile page.

US ANDA Litigation and Generic Entry Outlook for Noxafil

A generic version of NOXAFIL was approved as posaconazole by SINOTHERAPEUTICS INC on August 21st, 2019.

  Start Trial

Drug patent expirations by year for NOXAFIL
Drug Prices for NOXAFIL

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Recent Clinical Trials for NOXAFIL

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Cidara Therapeutics Inc.Phase 3
Novartis PharmaceuticalsPhase 1/Phase 2
Hospices Civils de LyonN/A

See all NOXAFIL clinical trials

Pharmacology for NOXAFIL
Paragraph IV (Patent) Challenges for NOXAFIL
Tradename Dosage Ingredient NDA Submissiondate
NOXAFIL SOLUTION;INTRAVENOUS posaconazole 205596 2015-11-24
NOXAFIL TABLET, DELAYED RELEASE;ORAL posaconazole 205053 2014-06-16
NOXAFIL SUSPENSION;ORAL posaconazole 022003 2011-02-28

US Patents and Regulatory Information for NOXAFIL

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 SOLUTION;INTRAVENOUS 205596-001 Mar 13, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Schering NOXAFIL posaconazole SUSPENSION;ORAL 022003-001 Sep 15, 2006 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Merck Sharp Dohme NOXAFIL posaconazole SOLUTION;INTRAVENOUS 205596-001 Mar 13, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Merck Sharp Dohme NOXAFIL posaconazole TABLET, DELAYED RELEASE;ORAL 205053-001 Nov 25, 2013 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Merck Sharp Dohme NOXAFIL posaconazole SOLUTION;INTRAVENOUS 205596-001 Mar 13, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Merck Sharp Dohme NOXAFIL posaconazole SOLUTION;INTRAVENOUS 205596-001 Mar 13, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Merck Sharp Dohme NOXAFIL posaconazole SOLUTION;INTRAVENOUS 205596-001 Mar 13, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for NOXAFIL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme NOXAFIL posaconazole SOLUTION;INTRAVENOUS 205596-001 Mar 13, 2014   Start Trial   Start Trial
Schering NOXAFIL posaconazole SUSPENSION;ORAL 022003-001 Sep 15, 2006   Start Trial   Start Trial
Schering NOXAFIL posaconazole SUSPENSION;ORAL 022003-001 Sep 15, 2006   Start Trial   Start Trial
Schering NOXAFIL posaconazole SUSPENSION;ORAL 022003-001 Sep 15, 2006   Start Trial   Start Trial
Merck Sharp Dohme NOXAFIL posaconazole TABLET, DELAYED RELEASE;ORAL 205053-001 Nov 25, 2013   Start Trial   Start Trial
Merck Sharp Dohme NOXAFIL posaconazole SOLUTION;INTRAVENOUS 205596-001 Mar 13, 2014   Start Trial   Start Trial
Merck Sharp Dohme NOXAFIL posaconazole TABLET, DELAYED RELEASE;ORAL 205053-001 Nov 25, 2013   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for NOXAFIL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0736030 300219 Netherlands   Start Trial 300219, 20141220, EXPIRES: 20191219
0736030 CA 2006 00002 Denmark   Start Trial
0736030 SPC/GB06/007 United Kingdom   Start Trial PRODUCT 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
0736030 8/2006 Austria   Start Trial PRODUCT 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
0736030 C00736030/01 Switzerland   Start Trial FORMER OWNER: SCHERING CORPORATION, US
0736030 C300219 Netherlands   Start Trial PRODUCT 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
0736030 06C0009 France   Start Trial PRODUCT NAME: POSACONAZOLE; REGISTRATION NO/DATE: EU/1/05/320/001 20051025
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Boehringer Ingelheim
Merck
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Express Scripts
McKinsey

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