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Last Updated: December 9, 2019

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Estradiol - Generic Drug Details

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What are the generic drug sources for estradiol and what is the scope of freedom to operate?

Estradiol is the generic ingredient in forty branded drugs marketed by Allergan Sales Llc, Alvogen Pine Brook, Mylan, Perrigo Uk Finco, Teva Pharms Usa, Bayer Hlthcare, Women First Hlthcare, Novartis, Amneal Pharms Llc, Mylan Technologies, Ortho Mcneil Pharm, Parke Davis, Noven, Mylan Speciality Lp, Ascend Theraps Us, Vertical Pharms Llc, Pharmacia And Upjohn, Therapeuticsmd Inc, Perrigo Pharma Intl, Bristol Myers Squibb, Barr Labs Inc, Epic Pharma Inc, Lannett Holdings Inc, Mayne Pharma, Usl Pharma, Duramed Pharms Barr, Novo Nordisk Inc, Amneal Pharms, Glenmark Pharms Ltd, Millicent, Apil, Dr Reddys, Watson Labs, Exeltis Usa Inc, Par Sterile Products, Am Regent, Fosun Pharma, Savage Labs, Noven Pharms Inc, Lupin Ltd, Accord Hlthcare, Barr, Breckenridge Pharm, Mylan Labs Ltd, Novast Labs, and Teva Womens, and is included in seventy NDAs. There are thirty patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Estradiol has two hundred and fifteen patent family members in twenty-five countries.

There are seventy-five drug master file entries for estradiol. Forty-one suppliers are listed for this compound. There are two tentative approvals for this compound.

Drug Prices for estradiol

See drug prices for estradiol

Drug Sales Revenue Trends for estradiol

See drug sales revenues for estradiol

Recent Clinical Trials for estradiol

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

SponsorPhase
Emory UniversityEarly Phase 1
Assistance Publique - Hôpitaux de ParisN/A
Vanderbilt University Medical CenterEarly Phase 1

See all estradiol clinical trials

Recent Litigation for estradiol

Identify potential future generic entrants

District Court Litigation
Case NameDate
Noven Pharmaceuticals, Inc. v. Actavis Laboratories UT, Inc.2018-05-18
Noven Pharmaceuticals, Inc. v. Amneal Pharmaceuticals LLC2018-05-08
Noven Pharmaceuticals, Inc. v. Mylan Technologies Inc.2017-12-08

See all estradiol litigation

PTAB Litigation
PetitionerDate
Mylan Technologies, Inc.2018-05-18
Mylan Technologies, Inc.2017-12-04

See all estradiol litigation

Generic filers with tentative approvals for ESTRADIOL
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial3MG;2MG;3MGTABLET;ORAL
  Start Trial  Start Trial1MG;2MG;2MGTABLET;ORAL
  Start Trial  Start Trial0.1MG/24HRFILM, EXTENDED RELEASE;TRANSDERMAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for estradiol
Drug ClassEstrogen
Mechanism of ActionEstrogen Receptor Agonists
Medical Subject Heading (MeSH) Categories for estradiol
Synonyms for estradiol
.alpha.-Oestradiol
.beta.-Estradiol
.beta.-Oestradiol
(+)-3,17.beta.-Estradiol
(+)-3,17b-Estradiol
(+)-3,17beta-Estradiol
(13S,17S)-13-methyl-7,8,9,11,12,13,14,15,16,17-decahydro-6H-cyclopenta[a]phenanthrene-3,17-beta-diol
(17?)-Estra-1,3,5(10)-triene-3,17-diol
(17b)-Estra-1,3,5(10)-triene-3,17-diol
(17beta)-Estra-1,3,5(10)-triene-3,17-diol
(17beta)-estra-1(10),2,4-triene-3,17-diol
(1S,10R,11S,14S,15S)-15-methyltetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadeca-2(7),3,5-triene-5,14-diol
(1S,10R,11S,14S,15S)-15-methyltetracyclo[8.7.0.0;{2,7}.0;{11,15}]heptadeca-2,4,6-triene-5,14-diol
(1S,10R,11S,14S,15S)-15-methyltetracyclo[8.7.0.0(2),.0(1)(1),(1)]heptadeca-2,4,6-triene-5,14-diol
(8''R'',9''S'',13''S'',14''S'',17''S'')-13-methyl-6,7,8,9,11,12,14,15,16,17-decahydrocyclopenta[''a'']phenanthrene-3,17-diol
(8R,9S,13S,14S,17S)-13-methyl-6,7,8,9,11,12,14,15,16,17-decahydrocyclopenta[a]phenanthrene-3,17-diol
(8R,9S,13S,14S,17S)-13-Methyl-7,8,9,11,12,13,14,15,16,17-decahydro-6H-cyclopenta[a]phenanthrene-3,17-diol
(8S,9S,13S,14S,17S)-13-Methyl-6,7,8,9,11,12,14,15,16,17-decahydrocyclopenta[a]phenanthrene-3,17-diol
(9beta,13alpha,14beta,17alpha)-estra-1,3,5(10)-triene-3,17-diol
[2,4,6,7-3H]-17beta-estradiol
[2,4,6,7-3H]-E2
[3H]-estradiol
[3H]-Estrogen
[3H]]estradiol
[3H]17beta-estradiol
[3H]E2
[3H]estradiol
003E693
1,3,5-Estratriene-3,17-beta-diol
1,3,5-Estratriene-3,17.beta.-diol
1,3,5-Estratriene-3,17beta-diol
1,3,5,(10)-Estratrien-3,17.beta.-diol
1,3,5(10)-estratriene-3,17b-diol
1,5-Estratriene-3,17.beta.-diol
1050677-52-5
1206475-11-7
125DP6010H
13b-Methyl-1,3,5(10)-gonatriene-3,17b-ol
13beta-Methyl-1,3,5(10)-gonatriene-3,17beta-ol
17 ?-Estradiol
17 beta-Estradiol
17-.BETA.-Estradiol
17-beta
17-beta-Estra-1,3,5(10)-triene-3,17-diol
17-beta-estradiol
17-beta-Estradiol 100 microg/mL in Acetonitrile
17-beta-Oestra-1,3,5(10)-triene-3,17-diol
17-beta-OH-estradiol
17-beta-OH-oestradiol
17-decahydrocyclopenta[a]phenanthrene-3,17-diol
17-E
17.beta.-Estra-1,3,5(10)-triene-3,17-diol
17.beta.-Estra-1,5(10)-triene-3,17-diol
17.beta.-Estradiol
17.beta.-Oestra-1,3,5(10)-triene-3,17-diol
17.beta.-Oestra-1,5(10)-triene-3,17-diol
17.beta.-Oestradiol
17.beta.-OH-estradiol
17.beta.-OH-oestradiol
17|A-estradiol;oestradiol;17|A-Oestradiol;|A-Estradiol
17|A-Oestradiol
17b-Estradiol
17b-Oestradiol
17beta estradiol (E2)
17beta oestradiol
17beta-Estra-1,3,5(10)-triene-3,17-diol
17beta-Estradiol
17beta-estradiol (E2)
17beta-Estradiol solution, 1.0 mg/mL in acetonitrile, ampule of 1 mL, certified reference material
17beta-Oestra-1,3,5(10)-triene-3,17-diol
17beta-Oestradiol
1a52
1g50
1jgl
1lhu
1qkt
1qku
2d06
2j7x
3,17-.beta.-Oestradiol
3,17-beta-Dihydroxy-1,3,5(10)-oestratriene
3,17-beta-Dihydroxyestra-1,3,5(10)-triene
3,17-beta-Dihydroxyoestra-1,3,5-triene
3,17-beta-Estradiol
3,17-beta-Oestradiol
3,17-dihydroxy-delta(1,3,5-10)-estratriene
3,17-Epidihydroxyestratriene
3,17-Epidihydroxyoestratriene
3,17.beta.-Dihydroxy-1,3,5(10)-estratriene
3,17.beta.-Dihydroxy-1,3,5(10)-oestratriene
3,17.beta.-Dihydroxyestra-1,3,5-triene
3,17.beta.-Dihydroxyestra-1,3,5(10)-triene
3,17.beta.-Dihydroxyoestra-1,3,5-triene
3,17.beta.-Estradiol
3,17b-Dihydroxyestra-1,3,5(10)-triene
3,17b-Estradiol
3,17beta-Dihydroxy-1,3,5(10)-estratriene
3,17beta-Dihydroxyestra-1,3,5-triene
3,17beta-dihydroxyestra-1,3,5(10)-trien
3,17beta-Dihydroxyestra-1,3,5(10)-triene
3,17beta-Dihydroxyoestra-1,3,5-triene
3,17beta-Estradiol
3,3,5-triene
3,3,5(10)-triene
4TI98Z838E
50-28-2
73459-61-7
873662-39-6
AB0012866
AB2000237
AC-22346
AC1L1L2K
ACN-S003579
Activella (Salt/Mix)
Aerodiol
AJ-64042
AKOS015896570
Alora
alpha-estradiol (obsolete)
Altrad
Amnestrogen
AN-6628
AOB5963
Aquadiol
AS-13729
B-Estradiol
B8B5AEF5-4957-49EB-A14F-444A8212C482
Bardiol
BC200811
BCP08579
BDBM17292
Benzogynestry
beta-Estradiol
beta-Estradiol, >=98%
beta-Estradiol, 98%
beta-Estradiol, analytical standard
beta-Estradiol, BioReagent, powder, suitable for cell culture
beta-Estradiol, powder, gamma-irradiated, suitable for cell culture
BIDD:ER0125
BIDD:PXR0065
Bio-E-Gel
Bio1_000403
Bio1_000892
Bio1_001381
Bio2_000363
Bio2_000843
bmse000642
BPBio1_000532
BRD-K18910433-001-04-4
BRD-K18910433-001-43-2
BSPBio_000482
BSPBio_001065
C00951
C18H24O2
CAS-50-28-2
CCG-100808
CCRIS 280
CHEBI:16469
CHEMBL135
cis-Estradiol
cis-Oestradiol
Climaderm
Climara
Climara (TN)
Climara Forte
Climara Pro (Salt/Mix)
Climara, Menostar
cMAP_000005
CMC_11154
Combipatch (Salt/Mix)
component of Menrium
Compudose
Compudose 200
Compudose 365
Corpagen
CPD000059126
CS-1938
D-3,17-beta-Estradiol
D-3,17-beta-Oestradiol
D-3,17.beta.-Estradiol
D-3,17.beta.-Oestradiol
D-3,17beta-Estradiol
D-3,17beta-Oestradiol
D-Estradiol
D-Oestradiol
D00105
DB00783
delta-Estradiol
delta-Oestradiol
Dermestril
Destradiol
dihydro-Theelin
Dihydrofollicular hormone
Dihydrofolliculin
Dihydromenformon
Dihydrotheelin
Dihydroxyesterin
Dihydroxyestrin
Dihydroxyoestrin
Dimenformon
Dimenformon prolongatum
Diogyn
Diogynets
Divigel
Divigel (TN)
DSSTox_CID_573
DSSTox_GSID_20573
DSSTox_RID_75666
DTXSID0020573
E 2
E 8875
E(sub 2)
E0025
EC 200-023-8
EINECS 200-023-8
Elestrim
Elestrin
Encore
Epiestriol 50
Epitope ID:136018
Esclim
Estasorb
Estra-1,3,5(10)-triene -3,17beta-diol
Estra-1,3,5(10)-triene-3,17-beta-diol
Estra-1,3,5(10)-triene-3,17-diol (17.beta.)-
Estra-1,3,5(10)-triene-3,17-diol (17beta)-
Estra-1,3,5(10)-triene-3,17-diol (17beta)-, homopolymer
Estra-1,3,5(10)-triene-3,17-diol, (17beta)-
Estra-1,3,5(10)-triene-3,17-diol(17b)-
Estra-1,3,5(10)-triene-3,17.beta.-diol
Estra-1,3,5(10)-triene-3,17b-diol
Estra-1,3,5(10)-triene-3,17beta-diol
Estra-1,5(10)-triene-3,17-diol (17.beta.)-
Estra-1,5(10)-triene-3,17-diol, (17.beta.)-
Estra-1,5(10)-triene-3,17.beta.-diol
estra-1(10),2,4-triene-3,17-diol, (17beta)-
Estrace
Estrace (TN)
Estraderm
Estraderm (TN)
Estraderm MX
Estraderm TTS
Estraderm TTS 100
Estraderm TTS 50
Estradiol (JAN/USP/INN)
Estradiol [USAN:INN]
Estradiol [USP:INN:BAN]
Estradiol complex
ESTRADIOL HEMIHYDRATE
Estradiol-17 alpha
Estradiol-17 beta
Estradiol-17-beta
Estradiol-17.beta.
estradiol-17beta
Estradiol-3,17beta
Estradiol, .beta.-
Estradiol, meets USP testing specifications
Estradiol, Pharmaceutical Secondary Standard; Certified Reference Material
Estradiol, United States Pharmacopeia (USP) Reference Standard
Estradiolo
Estradiolo [DCIT]
Estradiolum
Estradiolum [INN]
Estradot
Estraldine
Estrapak 50
Estrasorb
Estrasorb (TN)
Estreva
Estrifam
Estring
Estring (TN)
Estring vaginal ring
Estroclim
Estroclim 50
Estrodiolum
Estrodiolum [INN-Latin]
Estrofem 2
Estrofem Forte
Estrogel
Estrogel (TN)
Estrogel HBF
Estrogens, esterified
Estropause
Estrovite
EU-0100503
Evamist
Evorel
Extrasorb
Fem7
Femanest
Femestral
Femestrol
Femogen
Fempatch
Femtran
Follicyclin
Gelestra
Ginedisc
Ginosedol
GTPL1012
GTPL1013
Gynergon
Gynestrel
Gynodiol
Gynoestryl
GynPolar
HMS1362E07
HMS1569I04
HMS1792E07
HMS1990E07
HMS2051C17
HMS2090E18
HMS2096I04
HMS2236H04
HMS3261F07
HMS3403E07
HMS3713I04
HSDB 3589
HY-B0141
I06-2405
IDI1_002118
Innofem
Innofem (TN)
J10189
KBio2_000405
KBio2_002269
KBio2_002973
KBio2_004837
KBio2_005541
KBio2_007405
KBio3_000769
KBio3_000770
KBio3_002749
KBioGR_000405
KBioGR_002269
KBioSS_000405
KBioSS_002270
Lamdiol
LMST02010001
Lopac0_000503
LP00503
LS-137
Macrodiol
Macrol
Menest
Menorest
MFCD00003693
Microdiol
Minivelle
MLS000069494
MLS000758312
MLS001076331
MLS001424022
MolPort-001-794-632
NC00058
NCGC00091544-00
NCGC00091544-01
NCGC00091544-02
NCGC00091544-04
NCGC00091544-05
NCGC00091544-06
NCGC00091544-07
NCGC00091544-09
NCGC00091544-10
NCGC00091544-11
NCGC00091544-12
NCGC00091544-13
NCGC00091544-14
NCGC00091544-15
NCGC00091544-16
NCGC00179321-01
NCGC00179321-02
NCGC00254177-01
NCGC00259606-01
NCGC00261188-01
Nordicol
NSC-9895
NSC9895
Oesclim
Oestergon
Oestra-1,3,5(10)-triene-3,17-beta-diol
Oestra-1,3,5(10)-triene-3,17.beta.-diol
Oestra-1,3,5(10)-triene-3,17b-diol
Oestra-1,3,5(10)-triene-3,17beta-diol
Oestra-1,5(10)-triene-3,17.beta.-diol
Oestradiol
Oestradiol Berco
Oestradiol R
Oestradiol-17-beta
Oestradiol-17.beta.
Oestradiol-17beta
Oestradiol-17beta and esters
Oestradiol-17beta and esters [Steroidal oestrogens]
Oestradiolum
oestrodiol
Oestrogel
Oestroglandol
Oestrogynal
Opera_ID_1688
Ovahormon
Ovasterol
Ovastevol
Ovociclina
Ovocyclin
Ovocycline
Ovocylin
Perlatanol
Polyestradiol
Prestwick_207
Prestwick0_000441
Prestwick1_000441
Prestwick2_000441
Prestwick3_000441
Primofol
Profoliol
Profoliol B
progynon
Progynon DH
Progynon-DH
Q-201503
S-21400
s1709
Sandrena 1
Sandrena Gel
SC-25771
SCHEMBL8049
Sisare Gel
SK-Estrogens
SL-1100
SMP1_000121
SMR000059126
SPBio_002421
Spectrum5_002055
SR-01000075866
SR-01000075866-1
SR-01000075866-4
SR-01000721892
SR-01000721892-3
Syndiol
Systen
Theelin, dihydro-
Tox21_111148
Tox21_202057
Tox21_300288
Tox21_500503
Tradelia
Trial SAT
Trocosone
TX-004HR
UNII-125DP6010H
UNII-4TI98Z838E
Vagifem
Vagifem (TN)
Vivelle
Vivelle (TN)
VIVELLE-DOT
VOXZDWNPVJITMN-ZBRFXRBCSA-N
WLN: L E5 B666TTT&J E1 FQ OQ
Yuvvexy
Z-4415
Z1847670481
Zerella
Zesteem
Zesteen
ZINC13520815
Zumenon
Paragraph IV (Patent) Challenges for ESTRADIOL
Tradename Dosage Ingredient NDA Submissiondate
MINIVELLE FILM, EXTENDED RELEASE;TRANSDERMAL estradiol 203752 2015-05-08
MINIVELLE FILM, EXTENDED RELEASE;TRANSDERMAL estradiol 203752 2014-08-18
VAGIFEM TABLET;VAGINAL estradiol 020908 2013-01-02
VIVELLE-DOT FILM, EXTENDED RELEASE;TRANSDERMAL estradiol 020538 2010-04-27
CLIMARA FILM, EXTENDED RELEASE;TRANSDERMAL estradiol 020375 2005-09-12

US Patents and Regulatory Information for estradiol

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novast Labs ESTRADIOL AND NORETHINDRONE ACETATE estradiol; norethindrone acetate TABLET;ORAL 210612-001 Apr 3, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Apil FEMTRACE estradiol acetate TABLET;ORAL 021633-003 Aug 20, 2004 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Apil FEMTRACE estradiol acetate TABLET;ORAL 021633-002 Aug 20, 2004 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Therapeuticsmd Inc IMVEXXY estradiol INSERT;VAGINAL 208564-002 May 29, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Usl Pharma ESTRADIOL estradiol TABLET;ORAL 040297-003 Apr 17, 2002 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

Expired US Patents for estradiol

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare CLIMARA estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020375-005 May 27, 2003   Start Trial   Start Trial
Allergan Sales Llc ALORA estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020655-003 Dec 20, 1996   Start Trial   Start Trial
Novartis VIVELLE estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020323-005 Aug 16, 2000   Start Trial   Start Trial
Allergan Sales Llc ALORA estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020655-001 Dec 20, 1996   Start Trial   Start Trial
Novartis VIVELLE-DOT estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020538-005 Jan 8, 1999   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for estradiol

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0334429 97C0002 Belgium   Start Trial PRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305
1214076 C01214076/01 Switzerland   Start Trial PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
0771217 07C0001 France   Start Trial PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
0398460 04C0022 France   Start Trial PRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211
0136011 2000C/027 Belgium   Start Trial PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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