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Last Updated: November 12, 2019

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FASLODEX Drug Profile

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Which patents cover Faslodex, and what generic alternatives are available?

Faslodex is a drug marketed by Astrazeneca and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has seventy-one patent family members in forty countries.

The generic ingredient in FASLODEX is fulvestrant. There are twelve drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the fulvestrant profile page.

Drug patent expirations by year for FASLODEX
Drug Prices for FASLODEX

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Recent Clinical Trials for FASLODEX

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SponsorPhase
International Breast Cancer Study GroupPhase 3
PfizerPhase 1
Georgetown UniversityPhase 1

See all FASLODEX clinical trials

Recent Litigation for FASLODEX

Identify potential future generic entrants

District Court Litigation
Case NameDate
ASTRAZENECA PHARMACEUTICALS LP v. XIROMED, LLC2019-10-17
ASTRAZENECA PHARMACEUTICALS LP v. ACCORD HEALTHCARE, INC.2018-07-25
ASTRAZENECA PHARMACEUTICALS LP v. APOTEX INC.2018-06-29

See all FASLODEX litigation

PTAB Litigation
PetitionerDate
Fresenius Kabi USA, LLC2017-08-04
Fresenius Kabi USA,LLC2017-08-04
InnoPharma Licensing LLC2017-02-17

See all FASLODEX litigation

Synonyms for FASLODEX
(13S,17S)-13-Methyl-7-[9-(4,4,5,5,5-pentafluoro-pentane-1-sulfinyl)-nonyl]-7,8,9,11,12,13,14,15,16,17-decahydro-6H-cyclopenta[a]phenanthrene-3,17-diol
(1S,9R,10R,11S,14S,15S)-15-methyl-9-[9-(4,4,5,5,5-pentafluoropentanesulfinyl)nonyl]tetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadeca-2,4,6-triene-5,14-diol
(1S,9R,10R,11S,14S,15S)-15-methyl-9-[9-(4,4,5,5,5-pentafluoropentanesulfinyl)nonyl]tetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadeca-2(7),3,5-triene-5,14-diol
(7?,17?)-7-[9-[(4,4,5,5,5-Pentafluoropentyl)sulfinyl]nonyl]estra-1,3,5(10)-triene-3,17-diol
(7a,17b)-7-[9-[(4,4,5,5,5-pentafluoropentyl)sulfinyl]nonyl]estra-1,3,5(10)-triene-3,17-diol
(7a,17b)-7-[9-[(4,4,5,5,5pentafluoropentyl)Sulfinyl]nonyl]estra-1,3,5(10)-triene-3,17-diol
(7alpha,17beta)-7-{9-[(4,4,5,5,5-pentafluoropentyl)sulfinyl]nonyl}estra-1,3,5(10)-triene-3,17-diol
(7alpha,17beta)-7-{9-[(4,4,5,5,5-pentafluoropentyl)sulfinyl]nonyl}estra-1(10),2,4-triene-3,17-diol
(7R,13S,17S)-13-methyl-7-(9-(4,4,5,5,5-pentafluoropentylsulfinyl)nonyl)-7,8,9,11,12,13,14,15,16,17-decahydro-6H-cyclopenta[a]phenanthrene-3,17-diol
(7R,13S,17S)-13-Methyl-7-[9-(4,4,5,5,5-pentafluoro-pentane-1-sulfinyl)-nonyl]-7,8,9,11,12,13,14,15,16,17-decahydro-6H-cyclopenta[a]phenanthrene-3,17-diol
(7R,8R,9S,13S,14S,17S)-13-methyl-7-(9-((4,4,5,5,5-pentafluoropentyl)sulfinyl)nonyl)-7,8,9,11,12,13,14,15,16,17-decahydro-6H-cyclopenta[a]phenanthrene-3,17-diol
(7R,8R,9S,13S,14S,17S)-13-methyl-7-(9-(4,4,5,5,5-pentafluoropentyldihydrosulfinyl)nonyl)-7,8,9,11,12,13,14,15,16,17-decahydro-6H-cyclopenta[a]phenanthrene-3,17-diol
(7R,8R,9S,13S,14S,17S)-13-methyl-7-(9-(4,4,5,5,5-pentafluoropentylsulfinyl)nonyl)-7,8,9,11,12,13,14,15,16,17-decahydro-6H-cyclopenta[a]phenanthrene-3,17-diol
(7R,8R,9S,13S,14S,17S)-13-Methyl-7-[9-(4,4,5,5,5-pentafluoro-pentane-1-sulfinyl)-nonyl]-7,8,9,11,12,13,14,15,16,17-decahydro-6H-cyclopenta[a]phenanthrene-3,17-diol
(7R,8R,9S,13S,14S,17S)-13-methyl-7-[9-(4,4,5,5,5-pentafluoropentylsulfinyl)nonyl]-6,7,8,9,11,12,14,15,16,17-decahydrocyclopenta[a]phenanthrene-3,17-diol
(7R,8S,9S,13S,14S,17S)-13-methyl-7-[9-(4,4,5,5,5-pentafluoropentylsulfinyl) nonyl]-6,7,8,9,11,12,14,15,16,17-decahydrocyclopenta[a]phenanthrene-3,17-diol
129453-61-8
13-Methyl-7-[9-(4,4,5,5,5-pentafluoro-pentane-1-sulfinyl)-nonyl]-7,8,9,11,12,13,14,15,16,17-decahydro-6H-cyclopenta[a]phenanthrene-3,17-diol
13-Methyl-7-[9-(4,5,5,5-pentafluoropentylsulfinyl)nonyl]-7,8,9,11,12,13,14,15,16,17-decahydro-6H-cyclopenta[a]phenanthrene-3,17-diol
453F618
7alpha-(9-((4,4,5,5,5-Pentafluoropentyl)sulfinyl)nonyl)estra-1,3,5(10)-triene-3,17beta-diol
7alpha-(9-((4,4,5,5,5,-Pentafluoropentyl)sulfinyl)nonyl)estra-1,3,5(10)-triene-3,17beta-diol
7alpha-[9-(4,4,5,5,5-pentafluoro-pentylsulfinyl)nonyl]estra-1,3,5(10)-triene-3,17beta-diol
7alpha-[9[(4,4,5,5,5-Pentafluropentyl)sulfinyl]nonyl]-estra-1,3,5(10)-triene-3, 17 beta diol
7alpha-{9-[(4,4,5,5,5-pentafluoropentyl)sulfinyl]nonyl}estra-1(10),2,4-triene-3,17beta-diol
AB0012854
AB01273957_04
AB01273957-01
AB01273957-02
AB01273957-03
ABP001070
AC-4693
AC1L2XEN
ACN-029814
AKOS015895669
AN-5482
AS-13024
BC678123
BCP0726000227
BCP9000707
BDBM50169743
BIDD:ER0348
BIDD:PXR0136
BRD-A85667082-001-12-7
C-23331
C32H47F5O3S
CAS-129453-61-8
CC-28864
CCG-220082
CCG-221418
CCRIS 8741
CHEBI:31638
CHEMBL1358
CS-1267
CTK8F0501
D01161
DSSTox_CID_2369
DSSTox_GSID_22369
DSSTox_RID_76561
DTXSID4022369
Estra-1,3,5(10)-triene-3,17-diol, 7-(9-((4,4,5,5,5-pentafluoropentyl)sulfinyl)nonyl)-, (7alpha,17beta)-
Estra-1,3,5(10)-triene-3,17-diol, 7-[9-[(4,4,5,5,5-pentafluoropentyl)sulfinyl]nonyl]-, (7alpha,17beta)-
Estra-1,5(10)-triene-3,17-diol, 7-[9-[(4,4,5,5,5-pentafluoropentyl)sulfinyl]nonyl]-, (7.alpha.,17.beta.)-
EX-A959
Falsodex
Faslodex (TN)
Faslodex(ICI 182,780)
Fluvestrant
Fulvestrant
Fulvestrant (Faslodex)
Fulvestrant (JAN/USAN/INN)
Fulvestrant [USAN:USP:INN:BAN]
Fulvestrant [USAN]
Fulvestrant for system suitability, European Pharmacopoeia (EP) Reference Standard
Fulvestrant, >98% (HPLC)
Fulvestrant, European Pharmacopoeia (EP) Reference Standard
Fulvestrant, United States Pharmacopeia (USP) Reference Standard
Fulvestrant, Vetec(TM) reagent grade, >98%
fulvestrantum
GTPL1015
H046
HMS2090N22
HMS3260G10
HMS3712A06
HSDB 7658
HY-13636
I06-1109
ICI 182 780
ICI 182,780
ICI 182,789
Ici 182780
ICI-182780
ICI182780
J-005680
KB-77473
LP00114
LS-64781
MFCD00903953
MLS006010187
MolPort-035-395-691
NCGC00024964-02
NCGC00164789-02
NCGC00164789-04
NCGC00257357-01
NCGC00260152-01
NCGC00260799-01
NSC-719276
NSC719276
PubChem24291
RT-013311
S1191
SC-19202
SCHEMBL8209
SMR001456109
Tox21_110939
Tox21_110939_1
Tox21_202604
Tox21_303656
Tox21_500114
W-5207
ZD 182780
ZD 9238
ZD-182780
ZD-9238
ZD9238
ZM 182780
ZM-182780
Paragraph IV (Patent) Challenges for FASLODEX
Tradename Dosage Ingredient NDA Submissiondate
FASLODEX INJECTABLE;INTRAMUSCULAR fulvestrant 021344 2009-10-01

US Patents and Regulatory Information for FASLODEX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca FASLODEX fulvestrant INJECTABLE;INTRAMUSCULAR 021344-001 Apr 25, 2002 AO RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Astrazeneca FASLODEX fulvestrant INJECTABLE;INTRAMUSCULAR 021344-001 Apr 25, 2002 AO RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Astrazeneca FASLODEX fulvestrant INJECTABLE;INTRAMUSCULAR 021344-001 Apr 25, 2002 AO RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Astrazeneca FASLODEX fulvestrant INJECTABLE;INTRAMUSCULAR 021344-001 Apr 25, 2002 AO RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Astrazeneca FASLODEX fulvestrant INJECTABLE;INTRAMUSCULAR 021344-001 Apr 25, 2002 AO RX Yes Yes   Start Trial   Start Trial   Start Trial
Astrazeneca FASLODEX fulvestrant INJECTABLE;INTRAMUSCULAR 021344-001 Apr 25, 2002 AO RX Yes Yes   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

Supplementary Protection Certificates for FASLODEX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0138504 2004C/004 Belgium   Start Trial PRODUCT NAME: FULVESTRANT; REGISTRATION NO/DATE: EU/1/03/269/001 20040311
0138504 SPC/GB04/009 United Kingdom   Start Trial PRODUCT NAME: FULVESTRANT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTERED: UK EU/1/03/269/001 20040310
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Baxter
Johnson and Johnson
Express Scripts
Moodys

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