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. Eleven 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.
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Questions you can ask:
- What is the 5 year forecast for FLUCYTOSINE?
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- What is Average Wholesale Price for FLUCYTOSINE?
Summary for FLUCYTOSINE
| US Patents: | 0 |
| Applicants: | 5 |
| NDAs: | 6 |
| Finished Product Suppliers / Packagers: | 8 |
| Raw Ingredient (Bulk) Api Vendors: | 211 |
| Clinical Trials: | 35 |
| Patent Applications: | 4,650 |
| 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 |
|---|---|
| Huashan Hospital | Phase 4 |
| University of Minnesota | Phase 3 |
| Matinas BioPharma Nanotechnologies, Inc. | Phase 3 |
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 | ⤷ 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 | |||
| Hikma | FLUCYTOSINE | flucytosine | CAPSULE;ORAL | 206550-002 | Oct 17, 2017 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Strides Pharma | FLUCYTOSINE | flucytosine | CAPSULE;ORAL | 212632-002 | Apr 17, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sigmapharm Labs Llc | FLUCYTOSINE | flucytosine | CAPSULE;ORAL | 201566-002 | Jun 28, 2011 | AB | RX | 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 | |||
| Hikma | FLUCYTOSINE | flucytosine | CAPSULE;ORAL | 206550-001 | Oct 17, 2017 | 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 |
