Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 12, 2019

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Fluorouracil - Generic Drug Details

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What are the generic drug sources for fluorouracil and what is the scope of patent protection?

Fluorouracil is the generic ingredient in six branded drugs marketed by Valeant Pharms North, Bausch, Almirall, Mayne Pharma, Mylan, Taro, Hill Dermaceuticals, Pharmacia And Upjohn, Teva Parenteral, 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, Teva Pharms Usa, and Elorac, and is included in forty NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Fluorouracil has three patent family members in three countries.

There are fifteen drug master file entries for fluorouracil. Seventeen suppliers are listed for this compound.

Drug Prices for fluorouracil

See drug prices for fluorouracil

Drug Sales Revenue Trends for fluorouracil

See drug sales revenues for fluorouracil

Recent Clinical Trials for fluorouracil

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

SponsorPhase
IpsenPhase 3
Hematology/Oncology Pharmacy AssociationPhase 2
Shengjing HospitalPhase 4

See all fluorouracil clinical trials

Recent Litigation for fluorouracil

Identify potential future generic entrants

District Court Litigation
Case NameDate
Valeant International (Barbados) SRL v. Spear Pharmaceuticals, Inc.

See all fluorouracil litigation

Pharmacology for fluorouracil
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 040333-001 Jan 27, 2000 AP RX No Yes   Start Trial   Start Trial   Start Trial
Taro FLUOROURACIL fluorouracil CREAM;TOPICAL 090368-001 Mar 5, 2010 AB RX No No   Start Trial   Start Trial   Start Trial
Fresenius Kabi Usa FLUOROURACIL fluorouracil INJECTABLE;INJECTION 040278-001 Sep 30, 1998 AP RX No Yes   Start Trial   Start Trial   Start Trial
Spectrum Pharms FLUOROURACIL fluorouracil INJECTABLE;INJECTION 012209-002 Jul 29, 2016 DISCN Yes No   Start Trial   Start Trial   Start Trial
Taro FLUOROURACIL fluorouracil SOLUTION;TOPICAL 076526-001 Nov 5, 2003 AT RX 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

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Serving leading biopharmaceutical companies globally:

Colorcon
Moodys
Mallinckrodt
Boehringer Ingelheim
Medtronic
Merck

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.