Flucytosine - Generic Drug Details

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What are the generic drug 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, 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.

Summary for flucytosine

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

See drug prices for flucytosine

Recent Clinical Trials for flucytosine

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

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

See all flucytosine clinical trials

Pharmacology for flucytosine

Drug Class	Nucleoside Analog Antifungal

Medical Subject Heading (MeSH) Categories for flucytosine

Antifungal Agents
Antimetabolites

Anatomical Therapeutic Chemical (ATC) Classes for flucytosine

D01AE	Other antifungals for topical use
D01A	ANTIFUNGALS FOR TOPICAL USE
D01	ANTIFUNGALS FOR DERMATOLOGICAL USE
D	Dermatologicals

J02AX	Other antimycotics for systemic use
J02A	ANTIMYCOTICS FOR SYSTEMIC USE
J02	ANTIMYCOTICS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for flucytosine

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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
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
>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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