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Last Updated: August 19, 2022

VFEND Drug Patent Profile


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When do Vfend patents expire, and when can generic versions of Vfend launch?

Vfend is a drug marketed by Pf Prism Cv and is included in three NDAs.

The generic ingredient in VFEND is voriconazole. There are fourteen drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the voriconazole profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Vfend

A generic version of VFEND was approved as voriconazole by MYLAN PHARMS INC on April 22nd, 2010.

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Paragraph IV (Patent) Challenges for VFEND
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
VFEND Oral Suspension voriconazole 40 mg/mL 021630 1 2010-10-08
VFEND For Injection voriconazole 200 mg/vial 021267 1 2008-09-12
VFEND Tablets voriconazole 50 mg and 200 mg 021266 1 2008-04-14

US Patents and Regulatory Information for VFEND

VFEND is protected by zero US patents and one FDA Regulatory Exclusivity.

FDA Regulatory Exclusivity protecting VFEND

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Exclusivity Expiration: See Plans and Pricing

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 FOR SUSPENSION;ORAL 021630-001 Dec 19, 2003 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Pf Prism Cv VFEND voriconazole TABLET;ORAL 021266-002 May 24, 2002 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Pf Prism Cv VFEND voriconazole INJECTABLE;INTRAVENOUS 021267-001 May 24, 2002 AP RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Pf Prism Cv VFEND voriconazole TABLET;ORAL 021266-001 May 24, 2002 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 VFEND

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

EU/EMA Drug Approvals for VFEND

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Pfizer Europe MA EEIG Vfend voriconazole EMEA/H/C/000387
Voriconazole, is a broad spectrum, triazole antifungal agent and is indicated in adults and children aged 2 years and above as follows:treatment of invasive aspergillosis;treatment of in candidaemianon-neutropenic patients;treatment of fluconazole-resistant serious invasive Candida infections (including C. krusei);Treatment of serious fungal infections caused by Scedosporium spp. and Fusarium spp.Vfend should be administered primarily to patients with progressive, possibly life-threatening infections.Prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic stem cell transplant (HSCT) recipients.
Authorised no no no 2002-03-19
Accord Healthcare S.L.U. Voriconazole Accord voriconazole EMEA/H/C/002669
Voriconazole is a broad-spectrum, triazole antifungal agent and is indicated in adults and children aged two years and above as follows:treatment of invasive aspergillosis;treatment of candidaemia in non-neutropenic patients;treatment of fluconazole-resistant serious invasive Candida infections (including C. krusei);Treatment of serious fungal infections caused by Scedosporium spp. and Fusarium spp.Voriconazole Accord should be administered primarily to patients with progressive, possibly life-threatening infections.
Authorised yes no no 2013-05-16
Hikma Farmaceutica (Portugal) S.A. Voriconazole Hikma (previously Voriconazole Hospira) voriconazole EMEA/H/C/003737
Voriconazole is a broad spectrum, triazole antifungal agent and is indicated in adults and children aged 2 years and above as follows:treatment of invasive aspergillosis;treatment of candidaemia in non-neutropenic patients;treatment of fluconazole-resistant serious invasive Candida infections (including C. krusei);treatment of serious fungal infections caused by Scedosporium spp. and Fusarium spp.Voriconazole should be administered primarily to patients with progressive, possibly life-threatening infections.Prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic stem cell transplant (HSCT)recipients.
Authorised yes no no 2015-05-27
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for VFEND

See the table below for patents covering VFEND around the world.

Country Patent Number Title Estimated Expiration
African Regional IP Organization (ARIPO) 912 Pharmaceutical-formulations containing voriconazole. See Plans and Pricing
Israel 132918 PHARMACEUTICAL FORMULATIONS CONTAINING VORICONAZOLE AND A CYCLODEXTRIN DERIVATIVE See Plans and Pricing
World Intellectual Property Organization (WIPO) 9402518 See Plans and Pricing
Japan 2722277 See Plans and Pricing
Australia 625188 See Plans and Pricing
Canada 2119154 DERIVES DE CYCLODEXTRINES A SOLUBILITE AQUEUSE ACCRUE ET LEUR UTILISATION (DERIVATIVES OF CYCLODEXTRINS EXHIBITING ENHANCED AQUEOUS SOLUBILITY AND THE USE THEREOF) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for VFEND

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0440372 90960 Luxembourg See Plans and Pricing
0440372 02C0030 France See Plans and Pricing PRODUCT NAME: VORICONAZOLE; NAT. REGISTRATION NO/DATE: EU/1/02/212/001-025 20020319; FIRST REGISTRATION: EU/1/02/212/001-25 20020319
1001813 PA2003005 Lithuania See Plans and Pricing PRODUCT NAME: VORICONAZOLIS; REGISTRATION NO/DATE: 02/7890/8 20021002
0440372 SPC/GB02/031 United Kingdom See Plans and Pricing PRODUCT NAME: VORICONAZOLE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/02/212/001-025 20020319
0440372 C300100 Netherlands See Plans and Pricing PRODUCT NAME: VORICONAZOLUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/02/212/001-025 20020319
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 verification 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.