Last Updated: May 2, 2026

FLUCYTOSINE Drug Patent Profile

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When do Flucytosine patents expire, and when can generic versions of Flucytosine launch?

Flucytosine is a drug marketed by Aurobindo Pharma Ltd, Hikma, Laurus, Novel Labs Inc, Sigmapharm Labs Llc, and Strides Pharma. and is included in seven NDAs.

The generic ingredient in FLUCYTOSINE is flucytosine. There are seven drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the flucytosine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Flucytosine

A generic version of FLUCYTOSINE was approved as flucytosine by SIGMAPHARM LABS LLC on June 28^th, 2011.

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Summary for FLUCYTOSINE

US Patents:	0
Applicants:	6
NDAs:	7

US Patents and Regulatory Information for FLUCYTOSINE

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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
Aurobindo Pharma Ltd	FLUCYTOSINE	flucytosine	CAPSULE;ORAL	213665-001	May 1, 2020	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Novel Labs Inc	FLUCYTOSINE	flucytosine	CAPSULE;ORAL	204652-001	Jul 7, 2017	AB	RX	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
Strides Pharma	FLUCYTOSINE	flucytosine	CAPSULE;ORAL	212632-001	Apr 17, 2020	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Novel Labs Inc	FLUCYTOSINE	flucytosine	CAPSULE;ORAL	204652-002	Jul 7, 2017	AB	RX	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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