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

US Patents:	0
Tradenames:	2
Applicants:	3
NDAs:	3
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	43
Patent Applications:	5,926
Drug Prices:	Drug price trends for CIDOFOVIR
What excipients (inactive ingredients) are in CIDOFOVIR?	CIDOFOVIR excipients list
DailyMed Link:	CIDOFOVIR at DailyMed

See drug prices for CIDOFOVIR

Recent Clinical Trials for CIDOFOVIR

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

Sponsor	Phase
Biotest	Phase 2
Assistance Publique - Hôpitaux de Paris	Phase 3
University Hospital, Lille	Phase 2

See all CIDOFOVIR clinical trials

Pharmacology for CIDOFOVIR

Drug Class	Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor
Mechanism of Action	DNA Polymerase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for CIDOFOVIR

J05AB	Nucleosides and nucleotides excl. reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for CIDOFOVIR

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Glossary

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

Expired US Patents for CIDOFOVIR

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead Sciences Inc	VISTIDE	cidofovir	INJECTABLE;INJECTION	020638-001	Jun 26, 1996	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for CIDOFOVIR

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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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