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Last Updated: October 20, 2021

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Posaconazole - Generic Drug Details

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

Posaconazole is the generic ingredient in three branded drugs marketed by Msd Merck Co, Merck Sharp Dohme, Schering, Hikma Pharms, Aet Pharma, and Sinotherapeutics Inc, and is included in seven 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 ninety patent family members in twenty-one countries.

There are twenty-one drug master file entries for posaconazole. Seven suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for posaconazole

See drug prices for posaconazole

Recent Clinical Trials for posaconazole

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

SponsorPhase
Cedars-Sinai Medical CenterPhase 4
M.D. Anderson Cancer CenterPhase 1/Phase 2
ZonMw: The Netherlands Organisation for Health Research and DevelopmentPhase 3

See all posaconazole clinical trials

Generic filers with tentative approvals for POSACONAZOLE
Applicant Application No. Strength Dosage Form
⤷  Free Forever Trial⤷  Free Forever Trial300MG/16.7ML (18MG/ML)SOLUTION;INTRAVENOUS

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for posaconazole
Paragraph IV (Patent) Challenges for POSACONAZOLE
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 posaconazole

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;ORAL 205053-001 Nov 25, 2013 AB RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Merck Sharp Dohme NOXAFIL posaconazole SOLUTION;INTRAVENOUS 205596-001 Mar 13, 2014 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Merck Sharp Dohme NOXAFIL posaconazole SOLUTION;INTRAVENOUS 205596-001 Mar 13, 2014 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Merck Sharp Dohme NOXAFIL posaconazole SOLUTION;INTRAVENOUS 205596-001 Mar 13, 2014 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever 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 posaconazole

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

Supplementary Protection Certificates for posaconazole

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0736030 06C0009 France ⤷  Free Forever Trial PRODUCT NAME: POSACONAZOLE; REGISTRATION NO/DATE: EU/1/05/320/001 20051025
0736030 SPC/GB06/007 United Kingdom ⤷  Free Forever 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Moodys
AstraZeneca
McKesson
Dow
Johnson and Johnson

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