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Last Updated: October 31, 2024

CIDOFOVIR - Generic Drug Details


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What are the generic drug sources for cidofovir and what is the scope of freedom to operate?

Cidofovir is the generic ingredient in two branded drugs marketed by Avet Lifesciences, Mylan Institutional, and Gilead Sciences Inc, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for cidofovir. Two suppliers are listed for this compound.

Summary for CIDOFOVIR
Drug Prices for CIDOFOVIR

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Recent Clinical Trials for CIDOFOVIR

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

SponsorPhase
University Hospital, LillePhase 2
BiotestPhase 2
Assistance Publique - Hôpitaux de ParisPhase 3

See all CIDOFOVIR clinical trials

Pharmacology for CIDOFOVIR

US Patents and Regulatory Information for CIDOFOVIR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Avet Lifesciences CIDOFOVIR cidofovir INJECTABLE;INJECTION 202501-001 Jul 26, 2012 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Gilead Sciences Inc VISTIDE cidofovir INJECTABLE;INJECTION 020638-001 Jun 26, 1996 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mylan Institutional CIDOFOVIR cidofovir INJECTABLE;INJECTION 201276-001 Jun 27, 2012 AP RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for CIDOFOVIR

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Gilead Sciences International Limited Vistide cidofovir EMEA/H/C/000121
Vistide is indicated for the treatment of cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome (AIDS) and without renal dysfunction. Vistide should be used only when other agents are considered unsuitable.,
Withdrawn no no no 1997-04-23
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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