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Harvard Business School
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Argus Health

Generated: June 25, 2018

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Fulvestrant - Generic Drug Details

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

Fulvestrant
is the generic ingredient in one branded drug marketed by Astrazeneca and is included in one NDA. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Fulvestrant has seventy-one patent family members in forty countries.

There are eleven drug master file entries for fulvestrant. One supplier is listed for this compound.
Synonyms for fulvestrant
(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
7-(9-(4,4,5,5,5-pentafluoropentylsulfinyl)nonyl)estra-1,3,5(10)-triene-3,17-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,-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
AstraZeneca brand of fulvestrant
BC678123
BCP0726000227
BCP9000707
BDBM50169743
BIDD:ER0348
BIDD:PXR0136
C-23331
C32H47F5O3S
CAS-129453-61-8
CC-28864
CCG-220082
CCG-221418
CCRIS 8741
CHEBI:31638
CHEMBL1358
CS-1267
CTK8F0501
D01161
D0JO7Y
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
Faslodex (TN)
Faslodex, ICI 182780, Fulvestrant
Faslodex(ICI 182,780)
Fluvestrant
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
HSDB 7658
HY-13636
I06-1109
ICI 182,780
ICI 182,789
Ici 182780
ICI-182780
ICI182780
J-005680
KB-77473
LP00114
LP017067
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

US Patents and Regulatory Information for fulvestrant

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 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Astrazeneca FASLODEX fulvestrant INJECTABLE;INTRAMUSCULAR 021344-001 Apr 25, 2002 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Astrazeneca FASLODEX fulvestrant INJECTABLE;INTRAMUSCULAR 021344-001 Apr 25, 2002 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Astrazeneca FASLODEX fulvestrant INJECTABLE;INTRAMUSCULAR 021344-001 Apr 25, 2002 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
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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Supplementary Protection Certificates for fulvestrant

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
04C/004 Belgium ➤ Sign Up PRODUCT NAME: FULVESTRANT; REGISTRATION NO/DATE: EU/1/03/269/001 20040311
C/GB04/009 United Kingdom ➤ Sign Up PRODUCT NAME: FULVESTRANT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTERED: UK EU/1/03/269/001 20040310
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Accenture
Covington
US Army
McKesson
Boehringer Ingelheim
Colorcon
Cerilliant
AstraZeneca

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