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Last Updated: July 14, 2020

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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 two branded drugs marketed by Merck Sharp Dohme, Schering, Hikma, and Sinotherapeutics Inc, and is included in five 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 eighty-eight patent family members in twenty-one countries.

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

Drug Prices for posaconazole

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Recent Clinical Trials for posaconazole

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

SponsorPhase
Cidara Therapeutics Inc.Phase 3
Second Affiliated Hospital, School of Medicine, Zhejiang UniversityPhase 4
Novartis PharmaceuticalsPhase 1/Phase 2

See all posaconazole clinical trials

Generic filers with tentative approvals for POSACONAZOLE
Applicant Application No. Strength Dosage Form
  Start Trial  Start 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 SOLUTION;INTRAVENOUS 205596-001 Mar 13, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Hikma POSACONAZOLE posaconazole SUSPENSION;ORAL 208773-001 May 15, 2020 AB RX No No   Start Trial   Start Trial   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
>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 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
Schering NOXAFIL posaconazole SUSPENSION;ORAL 022003-001 Sep 15, 2006   Start Trial   Start 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 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 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:

Mallinckrodt
Moodys
AstraZeneca
McKesson
Dow
Johnson and Johnson

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