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Last Updated: March 19, 2024

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, Hainan Poly, Novel Labs Inc, Rising, Almaject, Eugia Pharma, Gland Pharma Ltd, Meitheal, Mylan Labs Ltd, 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-eight NDAs. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for voriconazole. Thirty-three 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
Gilead SciencesPhase 1
RenJi HospitalPhase 4
University Hospital, GenevaPhase 1

See all voriconazole clinical trials

Medical Subject Heading (MeSH) Categories for voriconazole
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
Teva Pharms VORICONAZOLE voriconazole TABLET;ORAL 091658-002 Apr 6, 2012 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Epic Pharma Llc VORICONAZOLE voriconazole TABLET;ORAL 207049-002 Sep 7, 2016 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Meitheal VORICONAZOLE voriconazole INJECTABLE;INTRAVENOUS 214516-001 May 9, 2022 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Gland Pharma Ltd VORICONAZOLE voriconazole INJECTABLE;INTRAVENOUS 211099-001 Mar 31, 2020 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurobindo Pharma Ltd VORICONAZOLE voriconazole TABLET;ORAL 206837-001 Jan 22, 2016 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Eugia Pharma VORICONAZOLE voriconazole INJECTABLE;INTRAVENOUS 212162-001 Feb 2, 2023 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan Labs Ltd VORICONAZOLE voriconazole INJECTABLE;INTRAVENOUS 210849-001 Oct 11, 2022 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 ⤷  Try a Trial ⤷  Try a Trial
Pf Prism Cv VFEND voriconazole FOR SUSPENSION;ORAL 021630-001 Dec 19, 2003 ⤷  Try a Trial ⤷  Try a Trial
Pf Prism Cv VFEND voriconazole TABLET;ORAL 021266-002 May 24, 2002 ⤷  Try a Trial ⤷  Try a Trial
Pf Prism Cv VFEND voriconazole TABLET;ORAL 021266-002 May 24, 2002 ⤷  Try a Trial ⤷  Try a Trial
Pf Prism Cv VFEND voriconazole INJECTABLE;INTRAVENOUS 021267-001 May 24, 2002 ⤷  Try a Trial ⤷  Try a Trial
Pf Prism Cv VFEND voriconazole TABLET;ORAL 021266-002 May 24, 2002 ⤷  Try a Trial ⤷  Try a Trial
Pf Prism Cv VFEND voriconazole TABLET;ORAL 021266-001 May 24, 2002 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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