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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 nine patents protecting this drug and three Paragraph IV challenges.

This drug has one hundred and thirty-eight 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.

Summary for NOXAFIL

International Patents:	138
US Patents:	9
Applicants:	2
NDAs:	3
Suppliers / Packagers:	1
Bulk Api Vendors:	64
Clinical Trials:	18
Patent Applications:	35
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for NOXAFIL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NOXAFIL
DailyMed Link:	NOXAFIL at DailyMed

Generic Entry Opportunity Date for NOXAFIL

NDA:

205596

Dosage:

SOLUTION;IV (INFUSION)

NDA:

022003

Dosage:

SUSPENSION;ORAL

NDA:

205053

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

Drug Class

Azole 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;INTRAVENOUS	205596-001	Mar 13, 2014		RX	Yes	Yes			Y
Merck Sharp Dohme	NOXAFIL	posaconazole	SOLUTION;INTRAVENOUS	205596-001	Mar 13, 2014		RX	Yes	Yes			Y	Y
Merck Sharp Dohme	NOXAFIL	posaconazole	SOLUTION;INTRAVENOUS	205596-001	Mar 13, 2014		RX	Yes	Yes			Y
Schering	NOXAFIL	posaconazole	SUSPENSION;ORAL	022003-001	Sep 15, 2006		RX	Yes	Yes			Y
Merck Sharp Dohme	NOXAFIL	posaconazole	SOLUTION;INTRAVENOUS	205596-001	Mar 13, 2014		RX	Yes	Yes			Y
Merck Sharp Dohme	NOXAFIL	posaconazole	SOLUTION;INTRAVENOUS	205596-001	Mar 13, 2014		RX	Yes	Yes			Y

Expired US Patents for NOXAFIL

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
Merck Sharp Dohme	NOXAFIL	posaconazole	SOLUTION;INTRAVENOUS	205596-001	Mar 13, 2014
Schering	NOXAFIL	posaconazole	SUSPENSION;ORAL	022003-001	Sep 15, 2006
Schering	NOXAFIL	posaconazole	SUSPENSION;ORAL	022003-001	Sep 15, 2006

Paragraph IV (Patent) Challenges for NOXAFIL

Drugname	Dosage	Strength	RLD	Date
	Injection	18 mg/mL, 16.7 mL vials
	Delayed-release Tablets	100 mg
	Oral Suspension	40 mg/mL

International Patents for NOXAFIL

Country	Document Number	Estimated Expiration
Mexico	9701229
Russian Federation	2013103724
Malaysia	130217
South Korea	20110010742
China	105288650
Germany	69428125

Supplementary Protection Certificates for NOXAFIL

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2006	Austria		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
00219	Netherlands		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
0219	Netherlands		300219, 20141220, EXPIRES: 20191219
216	Luxembourg		91216, EXPIRES: 20191220
0736030/01	Switzerland		FORMER OWNER: SCHERING CORPORATION, US
C003/2006	Ireland		SPC003/2006: 20061023, EXPIRES: 20191219