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Serving hundreds of leading biopharmaceutical companies globally:

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UBS
Boehringer Ingelheim
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Julphar
Mallinckrodt

Generated: April 19, 2019

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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 forty-two patent family members in thirty-four countries.

The generic ingredient in NOXAFIL is posaconazole. There are twenty-one 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
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-[(1S,2S)-1-ethyl-2-hydroxypropyl]-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
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
BCP01102
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
HSDB 7421
HY-17373
KS-00000GY1
KS-1413
M842
MMV688774
MolPort-006-666-426
Noxafil (TN)
P-7020
P2477
pasaconazole
PB30668
Posaconazole
Posaconazole (JAN/USAN/INN)
Posaconazole [USAN:INN:BAN]
Posaconazole in combination with MGCD290
Posaconazole solution, 2.0 mg/mL in methanol, ampule of 1 mL, certified reference material
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; Noxafil
SCH-56592
SCH56592
SCHEMBL991747
Schering 56592
ST24042909
SW219391-1
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;INTRAVENOUS 205596-001 Mar 13, 2014 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Merck Sharp Dohme NOXAFIL posaconazole SOLUTION;INTRAVENOUS 205596-001 Mar 13, 2014 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Merck Sharp Dohme NOXAFIL posaconazole SOLUTION;INTRAVENOUS 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 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 ➤ 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
Schering NOXAFIL posaconazole SUSPENSION;ORAL 022003-001 Sep 15, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
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 ➤ Try a Free Trial
➤ Subscribe Delayed-release Tablets 100 mg ➤ Subscribe ➤ Try a Free Trial
➤ Subscribe Oral Suspension 40 mg/mL ➤ Subscribe ➤ Try a Free Trial

Supplementary Protection Certificates for NOXAFIL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0736030 8/2006 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
0736030 91216 Luxembourg ➤ Try a Free Trial 91216, EXPIRES: 20191220
0736030 C00736030/01 Switzerland ➤ Try a Free Trial FORMER OWNER: SCHERING CORPORATION, US
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
UBS
Boehringer Ingelheim
Healthtrust
Fish and Richardson
Argus Health

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