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Last Updated: October 17, 2019

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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 patent protection?

Fulvestrant is the generic ingredient in two branded drugs marketed by Astrazeneca, Amneal Pharms Co, Glenmark Pharms Inc, Mylan Institutional, Sagent Pharms, Sandoz Inc, Fresenius Kabi Usa, and Teva Pharms Usa Inc, and is included in eight NDAs. There are seven 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 twelve drug master file entries for fulvestrant. Eight suppliers are listed for this compound.

Recent Clinical Trials for fulvestrant

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

SponsorPhase
SOLTI Breast Cancer Research GroupPhase 2
ARCAGY- GYNECOPhase 2
Taiho Oncology, Inc.Phase 2

See all fulvestrant clinical trials

Recent Litigation for fulvestrant

Identify potential future generic entrants

District Court Litigation
Case NameDate
ASTRAZENECA PHARMACEUTICALS LP v. ACCORD HEALTHCARE, INC.2018-07-25
ASTRAZENECA PHARMACEUTICALS LP v. APOTEX INC.2018-06-29
AstraZeneca Pharmaceuticals LP v. Fresenius Kabi USA, LLC2017-12-14

See all fulvestrant litigation

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

See all fulvestrant litigation

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
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
Faslodex (TN)
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
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

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
Fresenius Kabi Usa FULVESTRANT fulvestrant SOLUTION;INTRAMUSCULAR 210326-001 May 20, 2019 RX No No   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
Amneal Pharms Co FULVESTRANT fulvestrant INJECTABLE;INTRAMUSCULAR 210044-001 Mar 4, 2019 AO RX No No   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
Glenmark Pharms Inc FULVESTRANT fulvestrant INJECTABLE;INTRAMUSCULAR 207754-001 Aug 22, 2019 AO 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

Supplementary Protection Certificates for fulvestrant

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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Serving leading biopharmaceutical companies globally:

Moodys
Mallinckrodt
McKesson
Johnson and Johnson
Colorcon
Merck

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