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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Covington
Cerilliant
Mallinckrodt
Dow
Deloitte
Colorcon
Medtronic
Queensland Health

Generated: August 20, 2018

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 eight patents protecting this drug and three Paragraph IV challenges.

This drug has one hundred and thirty-five patent family members in thirty-four countries.

The generic ingredient in NOXAFIL is posaconazole. There are eighteen 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
Generic Entry Opportunity Date for NOXAFIL
Generic Entry Dates for NOXAFIL*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;IV (INFUSION)
Generic Entry Dates for NOXAFIL*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SUSPENSION;ORAL
Generic Entry Dates for NOXAFIL*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET, DELAYED RELEASE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NOXAFIL
Ingredient-typeAzoles
Drug ClassAzole Antifungal
Synonyms for NOXAFIL
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 (TN)
P-7020
P2477
pasaconazole
PB30668
posaconazol
Posaconazole
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 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;IV (INFUSION) 205596-001 Mar 13, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Schering NOXAFIL posaconazole SUSPENSION;ORAL 022003-001 Sep 15, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Merck Sharp Dohme NOXAFIL posaconazole SOLUTION;IV (INFUSION) 205596-001 Mar 13, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Schering NOXAFIL posaconazole SUSPENSION;ORAL 022003-001 Sep 15, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Merck Sharp Dohme NOXAFIL posaconazole SOLUTION;IV (INFUSION) 205596-001 Mar 13, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
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 NOXAFIL

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 ➤ Sign Up ➤ Sign Up
Merck Sharp Dohme NOXAFIL posaconazole TABLET, DELAYED RELEASE;ORAL 205053-001 Nov 25, 2013 ➤ Sign Up ➤ Sign Up
Schering NOXAFIL posaconazole SUSPENSION;ORAL 022003-001 Sep 15, 2006 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for NOXAFIL
Drugname Dosage Strength RLD Date
➤ Subscribe Injection 18 mg/mL, 16.7 mL vials ➤ Subscribe ➤ Sign Up
➤ Subscribe Delayed-release Tablets 100 mg ➤ Subscribe ➤ Sign Up
➤ Subscribe Oral Suspension 40 mg/mL ➤ Subscribe ➤ Sign Up

Non-Orange Book US Patents for 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
9,200,088 Sulfoalkyl ether cyclodextrin compositions ➤ Sign Up
5,693,626 Tetrahydrofuran antifungals ➤ Sign Up
5,714,490 Tetrahydrofuran antifungals ➤ Sign Up
5,703,236 Tetrahydrofuran antifungals ➤ Sign Up
7,635,773 Sulfoalkyl ether cyclodextrin compositions ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for NOXAFIL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2006 Austria ➤ Sign Up 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
2006 00002 Denmark ➤ Sign Up
00219 Netherlands ➤ Sign Up 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
C003/2006 Ireland ➤ Sign Up SPC003/2006: 20061023, EXPIRES: 20191219
C0009 France ➤ Sign Up PRODUCT NAME: POSACONAZOLE; REGISTRATION NO/DATE: EU/1/05/320/001 20051025
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
UBS
Johnson and Johnson
Fuji
Citi
Covington
Federal Trade Commission
US Army
Julphar

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