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Generated: July 16, 2018

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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 Merck Sharp Dohme and Schering, and is included in three NDAs. There are eight 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-five patent family members in thirty-four countries.

There are seventeen drug master file entries for posaconazole. One supplier is listed for this compound.
Pharmacology for posaconazole
Ingredient-typeAzoles
Drug ClassAzole Antifungal
Synonyms for posaconazole
1-((1S,2S)-1-Ethyl-2-hydroxypropyl)-4-{4-[4-(4-{[(5S,3R)-5-(2,4-difluorophenyl)-5-(1,2,4-triazolylmethyl)oxolan-3-yl]methoxy}phenyl)piperazinyl]phenyl}-1,2,4-triazolin-5-one
171228-49-2
177571-33-4
2,5-anhydro-1,3,4-trideoxy-2-(2,4-difluorophenyl)-4-({4-[4-(4-{1-[(2S,3S)-2-hydroxypentan-3-yl]-5-oxo-1,5-dihydro-4H-1,2,4-triazol-4-yl}phenyl)piperazin-1-yl]phenoxy}methyl)-1-(1H-1,2,4-triazol-1-yl)-D-threo-pentitol
228P492
3H-1,2,4-Triazol-3-one, 4-(4-(4-(4-((5-(2,4-difluorophenyl)tetrahydro-5-(1H-1,2,4-triazol-1-ylmethyl)-3-furanyl)methoxy)phenyl)-1-piperazinyl)phenyl)-2-(1-ethyl-2-hydroxypropyl)-2,4-dihydro-, (3R-(3alpha(1S*,2S*),5alpha))-
4-(4-(4-(4-(((3R,5R)-5-((1H-1,2,4-triazol-1-yl)methyl)-5-(2,4-difluorophenyl)-tetrahydrofuran-3-yl)methoxy)phenyl)piperazin-1-yl)phenyl)-2-((2S,3S)-2-hydroxypentan-3-yl)-2H-1,2,4-triazol-3(4H)-one
4-(4-(4-(4-(((3R,5R)-5-((1H-1,2,4-TRIAZOL-1-YL)METHYL)-5-(2,4-DIFLUOROPHENYL)TETRAHYDROFURAN-3-YL)METHOXY)PHENYL)PIPERAZIN-1-YL)PHENYL)-1-((2S,3S)-2-HYDROXYPENTAN-3-YL)-1H-1,2,4-TRIAZOL-5(4H)-ONE
4-(4-(4-(4-(((3R,5R)-5-(3,4-difluorophenyl)-5-(1H-1,2,4-triazol-1-yl)tetrahydrofuran-3-yl)methoxy)phenyl)piperazin-1-yl)phenyl)-1-((2S,3S)-2-hydroxypentan-3-yl)-1H-1,2,4-triazol-5(4H)-one
4-(4-(4-(4-(((5R)-5-((1H-1,2,4-triazol-1-yl)methyl)-5-(2,4-difluorophenyl)-tetrahydrofuran-3-yl)methoxy)phenyl)piperazin-1-yl)phenyl)-2-((2S,3S)-2-hydroxypentan-3-yl)-2H-1,2,4-triazol-3(4H)-one
4-(p-(4-(p-(((3R,5R)-5-(2,4-Difluorophenyl)tetrahydro-5-(1H-1,2,4-triazol-1-ylmethyl)-3-furyl)methoxy)phenyl)-1-piperazinyl)phenyl)-1-((1S,2S)-1-ethyl-2-hydroxypropyl)-delta(sup 2)-1,2,4-triazolin-5-one
4-[4-(4-{4-[(R)-5-(2,4-difluoro-phenyl)-5-(4,5-dihydro-[1,2,4]triazol-1-ylmethyl)-tetrahydro-furan-3-ylmethoxy]-phenyl}-piperazin-1-yl)-phenyl]-2-((1S,2S)-1-ethyl-2-hydroxy-propyl)-2,4-dihydro-[1,2,4]triazol-3-one
4-[4-[4-[4-[[(3R,5R)-5-(2,4-difluorophenyl)-5-(1,2,4-triazol-1-ylmethyl)oxolan-3-yl]methoxy]phenyl]piperazin-1-yl]phenyl]-2-[(2S,3S)-2-hydroxypentan-3-yl]-1,2,4-triazol-3-one
4-[4-[4-[4-[[(3R,5R)-5-(2,4-difluorophenyl)-5-(1,2,4-triazol-1-ylmethyl)tetrahydrofuran-3-yl]methoxy]phenyl]piperazin-1-yl]phenyl]-2-[(1S,2S)-1-ethyl-2-hydroxy-propyl]-1,2,4-triazol-3-one
4-{4-[4-(4-{[(3R,5R)-5-(2,4-difluorophenyl)-5-(1,2,4-triazol-1-ylmethyl)oxolan-3-yl]methoxy}phenyl)piperazin-1-yl]phenyl}-2-[(2S,3S)-2-hydroxypentan-3-yl]-1,2,4-triazol-3-one
4-{4-[4-(4-{[(3r,5r)-5-(2,4-difluorophenyl)-5-(1h-1,2,4-triazol-1-ylmethyl)tetrahydrofuran-3-yl]methoxy}phenyl)piperazin-1-yl]phenyl}-2-[(1s,2s)-1-ethyl-2-hydroxypropyl]-2,4-dihydro-3h-1,2,4-triazol-3-one
6TK1G07BHZ
AB0015409
AB01274762_02
AB01274762-01
AC-1350
AC1LAHLQ
ACN-040495
AK-72814
AKOS005145917
BC677686
BDBM50181473
C37H42F2N8O4
CHEBI:64355
CHEMBL1397
CP0094
CS-0998
CTK6B1621
D-threo-Pentitol, 2,5-anhydro-1,3,4-trideoxy-2-C-(2,4-difluorophenyl)-4-((4-(4-(4-(1-((1S,2S)-1-etyl-2-hydroxypropyl)-1,5-dihydro-5-oxo-4H-1,2,4-triazol-4-yl)phenyl)-1-piperazinyl)phenoxy)methyl)-1-(1H-1,2,4-triazol-1-yl)-
D02555
DB01263
FT-0657137
HE073055
HE317797
HSDB 7421
HY-17373
KS-00000GY1
KS-1413
M842
MFCD00941162
MMV688774
MolPort-006-666-426
Noxafil
Noxafil (TN)
P-7020
P2477
pasaconazole
PB30668
posaconazol
Posaconazole (JAN/USAN/INN)
Posaconazole [USAN:INN:BAN]
Posaconazole in combination with MGCD290
Posaconazole SP
Posaconazole, Antibiotic for Culture Media Use Only
Posaconazole, VETRANAL(TM), analytical standard
Posconazole
Q-4359
RAGOYPUPXAKGKH-XAKZXMRKSA-N
RL02201
RTR-007528
s1257
SC-23857
Sch 56592
SCH-56592
SCH56592
SCHEMBL991747
Schering 56592
Spriafil
ST24042909
TR-007528
UNII-6TK1G07BHZ
ZINC3938482

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

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Expired US Patents for posaconazole

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme NOXAFIL posaconazole SOLUTION;IV (INFUSION) 205596-001 Mar 13, 2014 ➤ Try a Free Trial ➤ Try a Free Trial
Schering NOXAFIL posaconazole SUSPENSION;ORAL 022003-001 Sep 15, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Merck Sharp Dohme NOXAFIL posaconazole TABLET, DELAYED RELEASE;ORAL 205053-001 Nov 25, 2013 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for 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 ➤ Try a Free Trial
5,703,079 Tetrahydrofuran antifungals ➤ Try a Free Trial
5,703,236 Tetrahydrofuran antifungals ➤ Try a Free Trial
5,710,154 Tetrahydrofuran antifungals ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for posaconazole

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0009 France ➤ Try a Free Trial PRODUCT NAME: POSACONAZOLE; REGISTRATION NO/DATE: EU/1/05/320/001 20051025
2006 Austria ➤ Try a Free 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
C/GB06/007 United Kingdom ➤ Try a Free 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
216 Luxembourg ➤ Try a Free Trial 91216, EXPIRES: 20191220
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Merck
Harvard Business School
McKinsey
Moodys
Deloitte
Johnson and Johnson
Federal Trade Commission
QuintilesIMS

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