FLUCYTOSINE - Generic Drug Details

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

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

There are seven drug master file entries for flucytosine. Eleven suppliers are listed for this compound.

Sponsor	Phase
Huashan Hospital	Phase 4
Matinas BioPharma Nanotechnologies, Inc.	Phase 3
University of Minnesota	Phase 3

Sponsor

Phase

Huashan Hospital

Phase 4

Matinas BioPharma Nanotechnologies, Inc.

Phase 3

University of Minnesota

Phase 3

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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
Strides Pharma	FLUCYTOSINE	flucytosine	CAPSULE;ORAL	207536-001	Jun 18, 2018		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma Ltd	FLUCYTOSINE	flucytosine	CAPSULE;ORAL	213665-002	May 1, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Strides Pharma	FLUCYTOSINE	flucytosine	CAPSULE;ORAL	207536-002	Jun 18, 2018		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sigmapharm Labs Llc	FLUCYTOSINE	flucytosine	CAPSULE;ORAL	201566-001	Jun 28, 2011	AB	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

US Patents:	0
Tradenames:	2
Applicants:	6
NDAs:	7
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	211
Clinical Trials:	35
Patent Applications:	7,391
Drug Prices:	Drug price trends for FLUCYTOSINE
What excipients (inactive ingredients) are in FLUCYTOSINE?	FLUCYTOSINE excipients list
DailyMed Link:	FLUCYTOSINE at DailyMed