FLUCYTOSINE Drug Patent Profile
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Which patents cover Flucytosine, and when can generic versions of Flucytosine launch?
Flucytosine is a drug marketed by Aurobindo Pharma Ltd, Hikma, Novel Labs Inc, Sigmapharm Labs Llc, and Strides Pharma. and is included in six NDAs.
The generic ingredient in FLUCYTOSINE is flucytosine. There are seven drug master file entries for this compound. Twelve 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 28th, 2011.
Summary for FLUCYTOSINE
US Patents: | 0 |
Applicants: | 5 |
NDAs: | 6 |
Finished Product Suppliers / Packagers: | 9 |
Raw Ingredient (Bulk) Api Vendors: | 211 |
Clinical Trials: | 34 |
Patent Applications: | 3,933 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for FLUCYTOSINE |
What excipients (inactive ingredients) are in FLUCYTOSINE? | FLUCYTOSINE excipients list |
DailyMed Link: | FLUCYTOSINE at DailyMed |
Recent Clinical Trials for FLUCYTOSINE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Minnesota | Phase 3 |
Matinas BioPharma Nanotechnologies, Inc. | Phase 3 |
Peking Union Medical College Hospital | N/A |
Pharmacology for FLUCYTOSINE
Drug Class | Nucleoside Analog Antifungal |
Medical Subject Heading (MeSH) Categories for FLUCYTOSINE
Anatomical Therapeutic Chemical (ATC) Classes for FLUCYTOSINE
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Aurobindo Pharma Ltd | FLUCYTOSINE | flucytosine | CAPSULE;ORAL | 213665-001 | May 1, 2020 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Sigmapharm Labs Llc | FLUCYTOSINE | flucytosine | CAPSULE;ORAL | 201566-001 | Jun 28, 2011 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Hikma | FLUCYTOSINE | flucytosine | CAPSULE;ORAL | 206550-002 | Oct 17, 2017 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |