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Voriconazole - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for voriconazole?

Voriconazole is the generic ingredient in two branded drugs marketed by Glenmark Pharms Ltd, Pf Prism Cv, Amneal Pharms, Aurobindo Pharma Ltd, Mylan Pharms Inc, Zydus Pharms Usa Inc, Akorn, Prinston Inc, Teva Pharms, Sandoz Inc, Appco Pharma Llc, Novel Labs Inc, Ajanta Pharma Ltd, and Alvogen Inc, and is included in nineteen NDAs. There is one patent protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has fifty-five patent family members in forty-five countries.

There are eleven drug master file entries for voriconazole. Twenty-seven suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: voriconazole

Tradenames:2
Patents:2
Applicants:14
NDAs:19
Drug Master File Entries: see list11
Suppliers / Packagers: see list27
Bulk Api Vendors: see list62
Clinical Trials: see list31
Patent Applications: see list2,964
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:voriconazole at DailyMed

Pharmacology for Ingredient: voriconazole

Tentative approvals for VORICONAZOLE

Applicant Application No. Form Dosage
► Subscribe► SubscribeINJECTABLE;INJECTION200MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Appco Pharma Llc
VORICONAZOLE
voriconazole
TABLET;ORAL206762-001May 24, 2016RXNoNo► Subscribe► Subscribe
Sandoz Inc
VORICONAZOLE
voriconazole
INJECTABLE;IV (INFUSION)090862-001May 30, 2012RXNoNo► Subscribe► Subscribe
Amneal Pharms
VORICONAZOLE
voriconazole
FOR SUSPENSION;ORAL205034-001Apr 13, 2016RXNoNo► Subscribe► Subscribe
Mylan Pharms Inc
VORICONAZOLE
voriconazole
FOR SUSPENSION;ORAL202361-001May 28, 2013RXNoNo► Subscribe► Subscribe
Pf Prism Cv
VFEND
voriconazole
TABLET;ORAL021266-002May 24, 2002RXYesYes► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: voriconazole

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pf Prism Cv
VFEND
voriconazole
INJECTABLE;IV (INFUSION)021267-001May 24, 20025,376,645► Subscribe
Pf Prism Cv
VFEND
voriconazole
FOR SUSPENSION;ORAL021630-001Dec 19, 20035,116,844► Subscribe
Pf Prism Cv
VFEND
voriconazole
TABLET;ORAL021266-002May 24, 20025,364,938► Subscribe
Pf Prism Cv
VFEND
voriconazole
INJECTABLE;IV (INFUSION)021267-001May 24, 20025,116,844► Subscribe
Pf Prism Cv
VFEND
voriconazole
TABLET;ORAL021266-002May 24, 20025,567,817► Subscribe
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International Patent Family for Ingredient: voriconazole

Country Document Number Estimated Expiration
TunisiaSN98090► Subscribe
Slovakia159399► Subscribe
Germany69814091► Subscribe
South Korea100372988► Subscribe
Iceland5248► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: VORICONAZOLE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2003005Lithuania► SubscribePRODUCT NAME: VORICONAZOLIS; REGISTRATION NO/DATE: 02/7890/8 20021002
C/GB02/031United Kingdom► SubscribePRODUCT NAME: VORICONAZOLE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/02/212/001-025 20020319
C0030France► SubscribePRODUCT NAME: VORICONAZOLE; NAT. REGISTRATION NO/DATE: EU/1/02/212/001-025 20020319; FIRST REGISTRATION: EU/1/02/212/001-25 20020319
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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