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FLUOROURACIL Drug Profile
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Which patents cover Fluorouracil, and what generic alternatives are available?
Fluorouracil is a drug marketed by Mayne Pharma, Mylan, Taro, Abic, Abraxis Pharm, Accord Hlthcare, Bedford, Ebewe Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Marchar, Mylan Labs Ltd, Sagent Pharms Inc, Sandoz, Smith And Nephew, Spectrum Pharms, and Teva Pharms Usa. and is included in thirty-one NDAs.
The generic ingredient in FLUOROURACIL is fluorouracil. There are fifteen drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the fluorouracil profile page.
US ANDA Litigation and Generic Entry Outlook for Fluorouracil
A generic version of FLUOROURACIL was launched as fluorouracil by FRESENIUS KABI USA on December 11th, 2019.
Summary for FLUOROURACIL
See drug prices for FLUOROURACIL
Recent Clinical Trials for FLUOROURACIL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Ipsen | Phase 3 |
| Hematology/Oncology Pharmacy Association | Phase 2 |
| Shengjing Hospital | Phase 4 |
Recent Litigation for FLUOROURACIL
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Valeant International (Barbados) SRL v. Spear Pharmaceuticals, Inc. |
Pharmacology for FLUOROURACIL
| Drug Class | Nucleoside Metabolic Inhibitor |
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Medical Subject Heading (MeSH) Categories for FLUOROURACIL
Synonyms for FLUOROURACIL
| (5-fluorouracil)5-Fluoro-1H-pyrimidine-2,4-dione |
| 1-fluoro-1h-pyrimidine-2,4-dione |
| 1004-03-1 |
| 191047-65-1 |
| 1upf |
| 2,3H)-Pyrimidinedione, 5-fluoro- |
| 2,4-Dihydroxy-5-fluoropyrimidine |
| 2,4-Dihydroxy-5-fluoropyrimidine; 5-Fluoro-2,4(1H,3H)-pyrimidinedione; 5-FU |
| 2,4-Dioxo-5-fluoropryimidine |
| 2,4-Dioxo-5-fluoropyrimidine |
| 2,4-Pyrimidinedione, 5-fluoro- |
| 2,4(1H,3H)-Pyrimidinedione, 5-fluoro- |
| 29507-EP2270008A1 |
| 29507-EP2270505A1 |
| 29507-EP2272827A1 |
| 29507-EP2289892A1 |
| 29507-EP2292234A1 |
| 29507-EP2292617A1 |
| 29507-EP2295426A1 |
| 29507-EP2295427A1 |
| 29507-EP2298305A1 |
| 29507-EP2308861A1 |
| 29507-EP2311842A2 |
| 42164-EP2272827A1 |
| 42164-EP2275420A1 |
| 42164-EP2277565A2 |
| 42164-EP2277566A2 |
| 42164-EP2277567A1 |
| 42164-EP2277568A2 |
| 42164-EP2277569A2 |
| 42164-EP2277570A2 |
| 42164-EP2277876A1 |
| 42164-EP2292280A1 |
| 42164-EP2292614A1 |
| 42164-EP2295412A1 |
| 42164-EP2295413A1 |
| 42164-EP2295416A2 |
| 42164-EP2298748A2 |
| 42164-EP2298764A1 |
| 42164-EP2298765A1 |
| 42164-EP2298778A1 |
| 42164-EP2305642A2 |
| 42164-EP2308833A2 |
| 42164-EP2311808A1 |
| 42164-EP2311829A1 |
| 42164-EP2311840A1 |
| 4921-97-5 |
| 4CA-0544 |
| 5 Fluorouracil |
| 5-Faracil |
| 5-florouracil |
| 5-Fluor-2,4-dihydroxypyrimidin |
| 5-Fluor-2,4-dihydroxypyrimidin [Czech] |
| 5-Fluor-2,4-pyrimidindiol |
| 5-Fluor-2,4-pyrimidindiol [Czech] |
| 5-Fluor-2,4(1H,3H)-pyrimidindion |
| 5-Fluor-2,4(1H,3H)-pyrimidindion [Czech] |
| 5-Fluoracil |
| 5-Fluoracil [German] |
| 5-Fluoracyl |
| 5-fluoro uracil |
| 5-fluoro-1,2,3,4-tetrahydropyrimidine-2,4-dione |
| 5-fluoro-1,3-dihydropyrimidine-2,4-dione |
| 5-fluoro-1H-pyrimidine-2,4-dione |
| 5-Fluoro-1H-pyrimidine-2,4-dione (5-Fluorouracil) |
| 5-Fluoro-1H-pyrimidine-2,4-dione (5-FU) |
| 5-Fluoro-1H-pyrimidine-2,4-dione(5-fluoro uracil) |
| 5-Fluoro-1H-pyrimidine-2,4-dione(5-fluorouracil)(5-FU) |
| 5-Fluoro-1H-pyrimidine-2,4-dione(5-FU) |
| 5-Fluoro-1H-pyrimidine-2,4-dione(5-FUra) |
| 5-Fluoro-1H-pyrimidine-2,4-dione(5FU) |
| 5-Fluoro-2,3H)-pyrimidinedione |
| 5-Fluoro-2,4-(1H,3H)-pyrimidinedione |
| 5-fluoro-2,4-dioxo-pyrimidin |
| 5-fluoro-2,4-Pyrimidinediol |
| 5-Fluoro-2,4-pyrimidinedione |
| 5-Fluoro-2,4(1H,3H)-pyrimidinedione |
| 5-fluoro-pyrimidine-2,4-diol |
| 5-fluoro-uracil |
| 5-Fluoropyrimidin-2,4-diol |
| 5-fluoropyrimidine-2,4-diol |
| 5-Fluoropyrimidine-2,4-dione |
| 5-fluoropyrimidine-2,4(1H,3H)-dione |
| 5-fluorouacil |
| 5-Fluorouracil |
| 5-Fluorouracil, >=99% (HPLC), powder |
| 5-Fluorouracil, 99% |
| 5-Fluorouracil, analytical standard |
| 5-Fluorouracil, certified reference material, TraceCERT(R) |
| 5-Fluorouracil, Vetec(TM) reagent grade, >=99% |
| 5-fluorourasil |
| 5-fluorpyrimidin-2,4-diol |
| 5-Fluoruracil |
| 5-Fluoruracil [German] |
| 5-Fluracil |
| 5-Ftouracyl |
| 5-FU |
| 5-FU (TN) |
| 51-21-8 |
| 51F218 |
| 5F-uracil |
| 5FU |
| 7375-EP2269989A1 |
| 7375-EP2269994A1 |
| 7375-EP2270008A1 |
| 7375-EP2270018A1 |
| 7375-EP2272827A1 |
| 7375-EP2272832A1 |
| 7375-EP2275102A1 |
| 7375-EP2275412A1 |
| 7375-EP2275413A1 |
| 7375-EP2277876A1 |
| 7375-EP2280012A2 |
| 7375-EP2281563A1 |
| 7375-EP2281815A1 |
| 7375-EP2287156A1 |
| 7375-EP2289892A1 |
| 7375-EP2292233A2 |
| 7375-EP2292614A1 |
| 7375-EP2292615A1 |
| 7375-EP2292617A1 |
| 7375-EP2295416A2 |
| 7375-EP2295426A1 |
| 7375-EP2295427A1 |
| 7375-EP2298748A2 |
| 7375-EP2298768A1 |
| 7375-EP2298772A1 |
| 7375-EP2298780A1 |
| 7375-EP2301928A1 |
| 7375-EP2301933A1 |
| 7375-EP2305219A1 |
| 7375-EP2305243A1 |
| 7375-EP2305640A2 |
| 7375-EP2305642A2 |
| 7375-EP2305671A1 |
| 7375-EP2305689A1 |
| 7375-EP2308833A2 |
| 7375-EP2308839A1 |
| 7375-EP2308855A1 |
| 7375-EP2308861A1 |
| 7375-EP2311807A1 |
| 7375-EP2311808A1 |
| 7375-EP2311825A1 |
| 7375-EP2311827A1 |
| 7375-EP2311829A1 |
| 7375-EP2311840A1 |
| 7375-EP2314590A1 |
| 7375-EP2316459A1 |
| 7375-EP2316831A1 |
| 7375-EP2316834A1 |
| 7375-EP2316974A1 |
| 7375-EP2374454A1 |
| 79108-01-3 |
| AB1000177 |
| AC-11201 |
| AC1L1FTE |
| AC1Q4N2X |
| ACMC-1ATRK |
| Adrucil |
| Adrucil (Fluorouracil) |
| Adrucil (ICN) |
| Adrucil (TN) |
| AI3-25297 |
| AJ-94651 |
| AKOS000119162 |
| AKOS003237897 |
| AKOS008044307 |
| AKOS022965835 |
| AM20100252 |
| AN-7240 |
| ANW-31214 |
| Arumel |
| BBL009635 |
| BC227022 |
| BCP02083 |
| BCP9000239 |
| BCPP000428 |
| BDBM50340677 |
| BRD-K24844714-001-02-1 |
| BSPBio_002048 |
| C07649 |
| C4H3FN2O2 |
| Carac |
| Carac (TN) |
| Carzonal |
| CAS-51-21-8 |
| CCG-39879 |
| CCRIS 2582 |
| CF0033 |
| CHEBI:46345 |
| CHEMBL185 |
| Cinco FU |
| CPD000038082 |
| CS-0993 |
| CTK1H0569 |
| CTK8H4220 |
| D00584 |
| DB-051923 |
| DB-065735 |
| DB00544 |
| DivK1c_000054 |
| DL-399 |
| DSSTox_CID_634 |
| DSSTox_GSID_20634 |
| DSSTox_RID_75705 |
| DTXSID2020634 |
| EC 200-085-6 |
| Effluderm |
| Effluderm (free base) |
| Efudex |
| Efudix |
| Efurix |
| EINECS 200-085-6 |
| EU-0100536 |
| F 6627 |
| F0151 |
| Fluoro Uracil |
| Fluoro-uracile |
| Fluoro-uracilo |
| Fluoroblastin |
| Fluoroplex |
| Fluoroplex (TN) |
| Fluorouracil - Adrucil |
| Fluorouracil (5-Fluoracil, 5-FU) |
| Fluorouracil (Adrucil) |
| Fluorouracil (JP17/USP/INN) |
| Fluorouracil [USAN:INN:BAN:JAN] |
| Fluorouracil [USAN:USP:INN:BAN:JAN] |
| Fluorouracil Cream |
| Fluorouracil, 5- |
| Fluorouracil, British Pharmacopoeia (BP) Reference Standard |
| Fluorouracil, European Pharmacopoeia (EP) Reference Standard |
| Fluorouracil, meets USP testing specifications |
| Fluorouracil, Pharmaceutical Secondary Standard; Certified Reference Material |
| Fluorouracil, United States Pharmacopeia (USP) Reference Standard |
| Fluorouracile |
| Fluorouracile [DCIT] |
| Fluorouracilo |
| Fluorouracilo [INN-Spanish] |
| Fluorouracilum |
| Fluorouracilum [INN-Latin] |
| Fluouracil |
| Fluracil |
| Fluracilum |
| Fluri |
| Fluril |
| Fluro Uracil |
| Fluroblastin |
| FT-0082524 |
| FT-0601511 |
| FT-0707652 |
| Ftoruracil |
| FU |
| GHASVSINZRGABV-UHFFFAOYSA-N |
| GTPL4789 |
| HMS1920O18 |
| HMS2090I04 |
| HMS2091F19 |
| HMS3259O03 |
| HMS3261L13 |
| HMS3654K22 |
| HMS3715H03 |
| HMS500C16 |
| HSDB 3228 |
| HY-90006 |
| I07-0022 |
| IDI1_000054 |
| IN1335 |
| InChI=1/C4H3FN2O2/c5-2-1-6-4(9)7-3(2)8/h1H,(H2,6,7,8,9 |
| inhibits thymilidate synthetase |
| KBio1_000054 |
| KBio2_001321 |
| KBio2_003889 |
| KBio2_006457 |
| KBio3_001268 |
| KBioGR_001253 |
| KBioSS_001321 |
| Kecimeton |
| KS-00000DY3 |
| KS-5129 |
| KSC270K6T |
| Lopac-F-6627 |
| Lopac0_000536 |
| LP00536 |
| LS-153 |
| LS40596 |
| MCULE-6338086431 |
| MFCD00006018 |
| MLS000069498 |
| MLS002415705 |
| MolPort-000-156-102 |
| MolPort-003-990-447 |
| NC00454 |
| NCGC00015442-01 |
| NCGC00015442-02 |
| NCGC00015442-03 |
| NCGC00015442-04 |
| NCGC00015442-05 |
| NCGC00015442-06 |
| NCGC00015442-07 |
| NCGC00015442-08 |
| NCGC00015442-09 |
| NCGC00015442-10 |
| NCGC00015442-11 |
| NCGC00015442-12 |
| NCGC00015442-15 |
| NCGC00015442-16 |
| NCGC00091349-01 |
| NCGC00091349-02 |
| NCGC00091349-03 |
| NCGC00091349-04 |
| NCGC00091349-05 |
| NCGC00091349-07 |
| NCGC00091349-08 |
| NCGC00254023-01 |
| NCGC00259884-01 |
| NCGC00261221-01 |
| NCI60_001652 |
| NINDS_000054 |
| NSC 19893 |
| NSC-19893 |
| NSC-757036 |
| NSC19893 |
| NSC757036 |
| Opera_ID_134 |
| Pharmakon1600-01500305 |
| Phthoruracil |
| Phtoruracil |
| pyrimidine antimetabolite: inhibits nucleic acid replication; tetratogen |
| Queroplex |
| Ro 2-9757 |
| Ro-2-9757 |
| Ro-29757 |
| RP19888 |
| RW2456 |
| s1209 |
| SAM002264615 |
| SBB085751 |
| SBI-0050519.P004 |
| SC-09038 |
| SCHEMBL3646 |
| SMR000038082 |
| SPBio_000291 |
| Spectrum_000841 |
| SPECTRUM1500305 |
| Spectrum2_000076 |
| Spectrum3_000434 |
| Spectrum4_000557 |
| Spectrum5_000718 |
| SR-01000075881 |
| SR-01000075881-1 |
| SR-01000075881-3 |
| SR-01000075881-5 |
| SRI-10792_07 |
| SRI-10792_08 |
| SRI-10792-04 |
| SRI-10792-05 |
| SRI-10792-06 |
| ST45025877 |
| STK297802 |
| STL367375 |
| SW199617-3 |
| Timazin |
| TL8006093 |
| Tolak |
| Tox21_110150 |
| Tox21_110150_1 |
| Tox21_202335 |
| Tox21_300112 |
| Tox21_500536 |
| U 8953 |
| U-8953 |
| U3P01618RT |
| Ulup |
| UNII-U3P01618RT |
| UPCMLD-DP130 |
| UPCMLD-DP130:001 |
| Uracil, 5-fluoro- |
| URF |
| W-202929 |
| W-5036 |
| W-60379 |
| WLN: T6MVMVJ EF |
| Z275128052 |
| ZINC38212689 |
Paragraph IV (Patent) Challenges for FLUOROURACIL
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| CARAC | CREAM;TOPICAL | fluorouracil | 020985 | 2011-07-29 |
US Patents and Regulatory Information for FLUOROURACIL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Teva Pharms Usa | FLUOROURACIL | fluorouracil | INJECTABLE;INJECTION | 040334-001 | Feb 25, 2000 | AP | RX | No | Yes | Start Trial | Start Trial | Start Trial | |||
| Sagent Pharms Inc | FLUOROURACIL | fluorouracil | INJECTABLE;INJECTION | 203608-001 | May 11, 2017 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Taro | FLUOROURACIL | fluorouracil | SOLUTION;TOPICAL | 076526-002 | Nov 5, 2003 | AT | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Mylan Labs Ltd | FLUOROURACIL | fluorouracil | INJECTABLE;INJECTION | 202668-001 | Jul 17, 2012 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Sandoz | FLUOROURACIL | fluorouracil | INJECTABLE;INJECTION | 091299-001 | May 2, 2011 | DISCN | 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 |
