VFEND Drug Patent Profile

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. Thirty-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 22^nd, 2010.

Summary for VFEND

US Patents:	0
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	127
Patent Applications:	5,541
Drug Prices:	Drug price information for VFEND
What excipients (inactive ingredients) are in VFEND?	VFEND excipients list
DailyMed Link:	VFEND at DailyMed

See drug prices for VFEND

Pharmacology for VFEND

Drug Class	Azole Antifungal
Mechanism of Action	Cytochrome P450 2C19 Inhibitors Cytochrome P450 2C9 Inhibitors Cytochrome P450 3A4 Inhibitors

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

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
Pf Prism Cv	VFEND	voriconazole	TABLET;ORAL	021266-002	May 24, 2002	AB	RX	Yes	Yes
Pf Prism Cv	VFEND	voriconazole	INJECTABLE;INTRAVENOUS	021267-001	May 24, 2002	AP	RX	Yes	Yes
Pf Prism Cv	VFEND	voriconazole	TABLET;ORAL	021266-001	May 24, 2002	AB	RX	Yes	No

Expired US Patents for VFEND

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

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

International Patents for VFEND

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

Country	Patent Number	Title	Estimated Expiration
Luxembourg	90960
New Zealand	247205	INTERMEDIATE COMPOUNDS: 4-ETHYL-5-FLUOROPYRIMIDINE AND 4-CHLORO-6-ETHYL-5-FLUOROPYRIMIDINE
Hungary	T56361
World Intellectual Property Organization (WIPO)	9402518
Yugoslavia	48105

Supplementary Protection Certificates for VFEND

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