VORICONAZOLE - Generic Drug Details

What are the generic 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, Hainan Poly, Novel Labs Inc, Rising, Almaject, Aspiro, Eugia Pharma, Gland Pharma Ltd, Meitheal, Norvium Bioscience, Sandoz Inc, Slate Run Pharma, UBI, Xellia Pharms Aps, Zydus Pharms, Ajanta Pharma Ltd, Aurobindo Pharma Ltd, Cadila, Chartwell Rx, Epic Pharma Llc, Glenmark Pharms Ltd, Mylan Pharms Inc, Prinston Inc, and Teva Pharms, and is included in twenty-nine NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for VORICONAZOLE

US Patents:	0
Tradenames:	2
Applicants:	25
NDAs:	29
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	36
Raw Ingredient (Bulk) Api Vendors:	127
Clinical Trials:	153
Patent Applications:	5,837
Drug Prices:	Drug price trends for VORICONAZOLE
What excipients (inactive ingredients) are in VORICONAZOLE?	VORICONAZOLE excipients list
DailyMed Link:	VORICONAZOLE at DailyMed

See drug prices for VORICONAZOLE

Recent Clinical Trials for VORICONAZOLE

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

Sponsor	Phase
Post Graduate Institute of Medical Education and Research, Chandigarh	Phase 3
Gilead Sciences	Phase 1
RenJi Hospital	Phase 4

See all VORICONAZOLE clinical trials

Pharmacology for VORICONAZOLE

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

Medical Subject Heading (MeSH) Categories for VORICONAZOLE

14-alpha Demethylase Inhibitors

Antifungal Agents

Cytochrome P-450 CYP3A Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for VORICONAZOLE

J02AC	Triazole and tetrazole derivatives
J02A	ANTIMYCOTICS FOR SYSTEMIC USE
J02	ANTIMYCOTICS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for VORICONAZOLE

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 VORICONAZOLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Slate Run Pharma	VORICONAZOLE	voriconazole	INJECTABLE;INTRAVENOUS	211661-001	Nov 30, 2018	AP	RX	No	No
Xellia Pharms Aps	VORICONAZOLE	voriconazole	INJECTABLE;INTRAVENOUS	208562-001	Mar 9, 2017	AP	RX	No	No
Mylan Pharms Inc	VORICONAZOLE	voriconazole	TABLET;ORAL	090547-002	Apr 22, 2010	AB	RX	No	No
Rising	VORICONAZOLE	voriconazole	TABLET;ORAL	206762-002	May 24, 2016	AB	RX	No	No
Aurobindo Pharma Ltd	VORICONAZOLE	voriconazole	TABLET;ORAL	206837-002	Jan 22, 2016	AB	RX	No	No

Expired US Patents for VORICONAZOLE

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 VORICONAZOLE

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