Last Updated: May 2, 2026

flucytosine - Profile


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What are the generic sources for flucytosine and what is the scope of patent protection?

Flucytosine is the generic ingredient in two branded drugs marketed by Bausch, Aurobindo Pharma Ltd, Hikma, Laurus, Novel Labs Inc, Sigmapharm Labs Llc, and Strides Pharma, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

Summary for flucytosine
US Patents:0
Tradenames:2
Applicants:7
NDAs:8

US Patents and Regulatory Information for flucytosine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bausch ANCOBON flucytosine CAPSULE;ORAL 017001-001 Approved Prior to Jan 1, 1982 AB RX Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Bausch ANCOBON flucytosine CAPSULE;ORAL 017001-002 Approved Prior to Jan 1, 1982 AB RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Aurobindo Pharma Ltd FLUCYTOSINE flucytosine CAPSULE;ORAL 213665-001 May 1, 2020 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Aurobindo Pharma Ltd FLUCYTOSINE flucytosine CAPSULE;ORAL 213665-002 May 1, 2020 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Hikma FLUCYTOSINE flucytosine CAPSULE;ORAL 206550-001 Oct 17, 2017 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Hikma FLUCYTOSINE flucytosine CAPSULE;ORAL 206550-002 Oct 17, 2017 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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