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Last Updated: May 24, 2020

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Voriconazole - Generic Drug Details

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What are the generic drug sources for voriconazole and what is the scope of patent protection?

Voriconazole is the generic ingredient in two branded drugs marketed by Pf Prism Cv, Amneal Pharms, Mylan Pharms Inc, Novel Labs Inc, Alvogen, Gland Pharma Ltd, Hainan Poly Pharm, Sandoz Inc, Zydus Pharms, Xellia Pharms Aps, Ajanta Pharma Ltd, Akorn, Appco, Aurobindo Pharma Ltd, Cadila, Glenmark Pharms Ltd, Prinston Inc, and Teva Pharms, and is included in twenty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for voriconazole. Twenty-six suppliers are listed for this compound.

Drug Prices for voriconazole

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Recent Clinical Trials for voriconazole

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

SponsorPhase
Second Affiliated Hospital, School of Medicine, Zhejiang UniversityPhase 4
Zambon SpAPhase 1
Instituto de Investigación Hospital Universitario La PazPhase 4

See all voriconazole clinical trials

Recent Litigation for voriconazole

Identify potential future generic entrants

District Court Litigation
Case NameDate
CELGENE CORPORATION v. DR. REDDY'S LABORATORIES, LTD.2019-07-12
CELGENE CORPORATION v. SYNTHON PHARMECEUTICALS, INC.2018-06-19
MERCK SHARP & DOHME CORP. v. MYLAN LABORATORIES LIMITED2018-03-29

See all voriconazole litigation

Medical Subject Heading (MeSH) Categories for voriconazole
Synonyms for voriconazole
(+/-)-Voriconazole
(2R,3S)-2-(2,4-Difluoro-phenyl)-3-(5-fluoro-pyrimidin-4-yl)-1-[1,2,4]triazol-1-yl-butan-2-ol
(2R,3S)-2-(2,4-Difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-((1H)-1,2,4-triazol-1-yl)-butan-2-ol
(2R,3S)-2-(2,4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1H-1,2,4-triazol-1-yl) butan-2-ol
(2R,3S)-2-(2,4-Difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1H-1,2,4-triazol-1-yl)-2-butanol
(2r,3s)-2-(2,4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1h-1,2,4-triazol-1-yl)butan-2-ol
(2R,3S)-2-(2,4-difluorophenyl)-3-(5-fluoropyrimidin-4-yl)-1-(1,2,4-triazol-1-yl)butan-2-ol
(2R,3S)-2-(2,4-difluorophenyl)-3-(5-fluoropyrimidin-4-yl)-1-(1H-1,2,4-triazol-1-yl)butan-2-ol
(2R,3S)-2,3-bis(2,4-difluorophenyl)-1-(1H-1,2,4-triazol-1-yl)butan-2-ol
(alphaR,betaS)-alpha-(2,4-Difluorophenyl)-5-fluoro-beta-methyl-alpha-(1H-1,2,4-triazol-1-ylmethyl)-4-pyrimidineethanol
(alphaR,betaS)-alpha-(2,4-difluorophenyl)-5-fluoro-beta-methyl-alpha(1H-1,2,4-triazol-1-ylmethyl)-4-pyrimidineethanol
(R-(R*,S*))-alpha-(2,4-difluorophenyl)-5-fluoro-beta-methyl-alpha-(1H-1,2,4-triazol-1-ylmethyl)-4-pyrimidineethanol
137234-62-9
188416-29-7
2-(2,4-difluorophenyl)-3-(5-fluoropyrimidin-4-yl)-1-(1H-1,2,4-triazol-1-yl) butan-2-ol
234V629
2R,3S-2-(2,4-Difluorophenyl)-3-(5-fluoropyrimidin-4-yl)-1-(1H-1,2,4-triazol-1-yl)butan-2-ol
4-Pyrimidineethanol, alpha-(2,4-difluorophenyl)-5-fluoro-beta-methyl-alpha-(1H-1,2,4-triazol-1-ylmethyl)-, (alphaR,betaS)-
4-Pyrimidineethanol, alpha-(2,4-difluorophenyl)-5-fluoro-beta-methyl-alpha-(1H-1,2,4-triazol-1-ylmethyl)-, (alphaR,betaS)-rel-
4-Pyrimidineethanol, alpha-(2,4-difluorophenyl)-5-fluoro-beta-methyl-alpha-(1H-1,2,4-triazol-1-ylmethyl)-, (R-(R*,S*))-
AB0013963
AB00639948_07
AB00639948_08
AB00639948-04
AB00639948-06
AC-823
AKOS005145705
BCEHBSKCWLPMDN-MGPLVRAMSA-N
BCPP000019
BDBM50333117
C07622
C16H14F3N5O
CAS-137234-62-9
CCG-100941
CHEBI:10023
CHEMBL638
CPD000466350
CS-1227
CTK8E9205
D00578
DB00582
DRG-0301
DSSTox_CID_26485
DSSTox_GSID_46485
DSSTox_RID_81656
DTXSID5046485
FT-0082604
FT-0631154
HMS2051N09
HMS3260M22
HMS3713F12
HY-76200
I992
J-006986
J10329
JFU09I87TR
KS-0000001W
KS-1157
LS-181799
MFCD00905717
MLS000759464
MLS001424082
MLS006010028
NC00191
NCGC00164622-01
NCGC00164622-02
NCGC00164622-04
NCGC00260835-01
NSC-759888
NSC759888
Pfizer
Pharmakon1600-01502346
Q412236
RT-016239
s1442
SAM001246664
SB17419
SC-25806
SCHEMBL36233
SMR000466350
SW197571-2
SYN3012
Tox21_112241
Tox21_112241_1
Tox21_500150
UK 109496
UK-109,496
UK-109496
UNII-JFU09I87TR
UNII-USG4B1CD29 component BCEHBSKCWLPMDN-MGPLVRAMSA-N
VCZ
Vfend
Vfend (TN)
VFEND I.V.
Voriconazol
Voriconazole - Vfend
Voriconazole (JP17/USAN/INN)
Voriconazole [USAN:INN:BAN]
Voriconazole 2.0 mg/ml in Methanol
Voriconazole in combination with MGCD290
Voriconazole related compound A
Voriconazole related compound A RS [USP]
Voriconazole, (+/-)-
Voriconazole, >=98% (HPLC)
Voriconazole, 98%
Voriconazole, European Pharmacopoeia (EP) Reference Standard
Voriconazole, Pharmaceutical Secondary Standard: Certified Reference Material
Voriconazole, United States Pharmacopeia (USP) Reference Standard
Voriconazole, VETRANAL(TM), analytical standard
Voriconazolum
Vorikonazole
VRC
W-5208
Z2616414875
ZINC14864
Paragraph IV (Patent) Challenges for VORICONAZOLE
Tradename Dosage Ingredient NDA Submissiondate
VFEND FOR SUSPENSION;ORAL voriconazole 021630 2010-10-08
VFEND INJECTABLE;INTRAVENOUS voriconazole 021267 2008-09-12
VFEND TABLET;ORAL voriconazole 021266 2008-04-14

US Patents and Regulatory Information for voriconazole

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pf Prism Cv VFEND voriconazole TABLET;ORAL 021266-002 May 24, 2002 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Pf Prism Cv VFEND voriconazole INJECTABLE;INTRAVENOUS 021267-001 May 24, 2002 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
Novel Labs Inc VORICONAZOLE voriconazole TABLET;ORAL 207371-002 May 24, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Novel Labs Inc VORICONAZOLE voriconazole TABLET;ORAL 207371-001 May 24, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Ajanta Pharma Ltd VORICONAZOLE voriconazole TABLET;ORAL 206181-002 May 24, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for voriconazole

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pf Prism Cv VFEND voriconazole INJECTABLE;INTRAVENOUS 021267-001 May 24, 2002   Start Trial   Start Trial
Pf Prism Cv VFEND voriconazole FOR SUSPENSION;ORAL 021630-001 Dec 19, 2003   Start Trial   Start Trial
Pf Prism Cv VFEND voriconazole FOR SUSPENSION;ORAL 021630-001 Dec 19, 2003   Start Trial   Start Trial
Pf Prism Cv VFEND voriconazole TABLET;ORAL 021266-002 May 24, 2002   Start Trial   Start Trial
Pf Prism Cv VFEND voriconazole TABLET;ORAL 021266-002 May 24, 2002   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Moodys
Medtronic
McKinsey
Baxter
AstraZeneca

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