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NOXAFIL Drug Profile

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Which patents cover Noxafil, and when can generic versions of Noxafil launch?

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-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. Three suppliers are listed for this compound. Additional details are available on the posaconazole profile page.

US ANDA Litigation and Generic Entry Outlook for Noxafil

A generic version of NOXAFIL was approved as posaconazole by SINOTHERAPEUTICS INC on August 21^st, 2019.

Summary for NOXAFIL

International Patents:	148
US Patents:	8
Applicants:	2
NDAs:	3
Suppliers / Packagers:	2
Bulk Api Vendors:	70
Clinical Trials:	18
Patent Applications:	37
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

See drug prices for NOXAFIL

Recent Clinical Trials for NOXAFIL

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

Sponsor	Phase
Novartis Pharmaceuticals	Phase 1/Phase 2
Hospices Civils de Lyon	N/A
Bochud Pierre-Yves	N/A

See all NOXAFIL clinical trials

Recent Litigation for NOXAFIL

Identify potential future generic entrants

District Court Litigation

Case Name	Date
MERCK SHARP & DOHME CORP. v. SANDOZ INC.	2020-01-23
CyDex Pharmaceuticals, Inc. v. Alembic Global Holding SA	2019-05-23
MERCK SHARP & DOHME CORP. v. MYLAN LABORATORIES LIMITED	2018-03-29

See all NOXAFIL litigation

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

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-(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

ACN-040495

AK-72814

AKOS005145917

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

Noxafil (TN)

P-7020

P2477

pasaconazole

PB30668

PCZ

POS

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

Q906453

RAGOYPUPXAKGKH-XAKZXMRKSA-N

RTR-007528

s1257

SC-23857

Sch 56592

SCH-56592

SCH56592

SCHEMBL991747

Schering 56592

ST24042909

SW219391-1

TR-007528

UNII-6TK1G07BHZ

ZINC3938482

Paragraph IV (Patent) Challenges for NOXAFIL

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 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	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
Schering	NOXAFIL	posaconazole	SUSPENSION;ORAL	022003-001	Sep 15, 2006		RX	Yes	Yes			Y	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
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	SOLUTION;INTRAVENOUS	205596-001	Mar 13, 2014
Merck Sharp Dohme	NOXAFIL	posaconazole	TABLET, DELAYED RELEASE;ORAL	205053-001	Nov 25, 2013
Schering	NOXAFIL	posaconazole	SUSPENSION;ORAL	022003-001	Sep 15, 2006
Schering	NOXAFIL	posaconazole	SUSPENSION;ORAL	022003-001	Sep 15, 2006
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

International Patents for NOXAFIL

Country	Patent Number	Estimated Expiration
South Korea	20110010742
South Korea	101834024
Brazil	1100154
Hungary	9701690
South Africa	200307684
Japan	2016166368
Netherlands	300219

Supplementary Protection Certificates for NOXAFIL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0736030	SPC003/2006	Ireland		SPC003/2006: 20061023, EXPIRES: 20191219
0736030	CA 2006 00002	Denmark
0736030	C300219	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
0736030	8/2006	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
0736030	06C0009	France		PRODUCT NAME: POSACONAZOLE; REGISTRATION NO/DATE: EU/1/05/320/001 20051025
0736030	91216	Luxembourg		91216, EXPIRES: 20191220
0736030	C00736030/01	Switzerland		FORMER OWNER: SCHERING CORPORATION, US