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FDA Orange Book · active-ingredient family

Cidofovir

Cidofovir is approved as 1 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:VISTIDE · NDA 020638

1

Brand (NDA)

2

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · solution

ProductApplicantApplicationTEApproved
VISTIDERLDGILEAD SCIENCES INCNDA 020638Jun 26, 1996

Generic (ANDA) products (2)

ProductApplicantApplicationTEApproved
CIDOFOVIRAVET LIFESCIENCESANDA 202501APJul 26, 2012
CIDOFOVIRMYLAN INSTITUTIONALANDA 201276APJun 27, 2012

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Cidofovir — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.