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Estradiol - Generic Drug Details

What are the generic drug sources for estradiol and what is the scope of estradiol patent protection?
Estradiol is the generic ingredient in thirty-eight branded drugs marketed by Allergan Sales Llc, Alvogen Pine Brook, Mylan Pharms Inc, Perrigo Uk Finco, Teva Pharms Usa, Bayer Hlthcare, Women First Hlthcare, Novartis, Mylan Technologies, Ortho Mcneil Pharm, Parke Davis, Noven, Mylan Speciality Lp, Ascend Theraps Us, Vertical Pharms Llc, Pharmacia And Upjohn, Perrigo Pharma Intl, Bristol Myers Squibb, Barr Labs Inc, Epic Pharma Inc, Lannett Holdings Inc, Mayne Pharma, Mylan, Usl Pharma, Duramed Pharms Barr, Novo Nordisk Inc, Amneal Pharms, Apil, Watson Labs, Exeltis Usa Inc, Par Sterile Products, Fosun Pharma, Luitpold, Watson Labs Inc, Savage Labs, Noven Pharms Inc, Amneal Pharms Llc, Lupin Ltd, Accord Hlthcare, Barr, Breckenridge Pharm, Mylan Labs Ltd, and Teva Womens, and is included in sixty-four NDAs. There are fourteen patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Estradiol has one hundred and fourteen patent family members in twenty-four countries.

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

Summary for estradiol

International Patents:	114
US Patents:	14
Tradenames:	38
Applicants:	43
NDAs:	64
Drug Master File Entries:	75
Suppliers / Packagers:	45
Bulk Api Vendors:	80
Clinical Trials:	701
Patent Applications:	7,070
Formulation / Manufacturing:	see details
Drug Prices:	see low prices
DailyMed Link:	estradiol at DailyMed

Pharmacology for estradiol

Ingredient-type	Estradiol Congeners
Drug Class	Estrogen
Mechanism of Action	Estrogen Receptor Agonists

Medical Subject Heading (MeSH) Categories for estradiol

Estrogens

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
(1S,10R,11S,14S,15S)-15-METHYLTETRACYCLO[8.7.0.0(2),?.0(1)(1),(1)?]HEPTADECA-2(7),3,5-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
[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
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 hemihydrate 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)
Activella (TN)
Aerodiol
AJ-64042
AK167943
AKOS015896570
Alora
Alora (TN)
alpha-estradiol (obsolete)
alpha-Oestradiol
Altrad
Amnestrogen
AN-6628
Angeliq (TN)
AOB5963
Aquadiol
AS-13729
B-Estradiol
B8B5AEF5-4957-49EB-A14F-444A8212C482
Bardiol
BC200811
BDBM17292
Benzogynestry
beta-Estradiol
beta-Estradiol, >=98%
beta-Estradiol, analytical standard
beta-Estradiol, BioReagent, powder, suitable for cell culture
beta-Estradiol, powder, gamma-irradiated, BioXtra, suitable for cell culture
beta-Oestradiol
BIDD:ER0125
BIDD:PXR0065
Bio-0812
Bio-E-Gel
Bio1_000403
Bio1_000892
Bio1_001381
Bio2_000363
Bio2_000843
bmse000642
BPBio1_000532
BRD-K18910433-001-04-4
BSPBio_000482
BSPBio_001065
BT000387
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
D08QMX
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
Elestrin (TN)
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 (TN)
Estraderm TTS 100
Estraderm TTS 50
Estradiol - Acrux
Estradiol (JAN/USP/INN)
Estradiol [USAN:INN]
Estradiol [USP:INN:BAN]
Estradiol acetate (TN)
Estradiol complex
Estradiol cypionate (TN)
ESTRADIOL HEMIHYDRATE
Estradiol valerate (TN)
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; traceable to USP, PhEur and BP
Estradiol, United States Pharmacopeia (USP) Reference Standard
Estradiolo
Estradiolo [DCIT]
Estradiolum
Estradiolum [INN]
Estradot
Estraldine
Estrapak 50
Estrasorb
Estrasorb (TN)
Estrasorb Topical (TN)
Estreva
Estrifam
Estring
Estring (TN)
Estring vaginal ring
Estroclim
Estroclim 50
Estrodiolum
Estrodiolum [INN-Latin]
Estrofem (TN)
Estrofem 2
Estrofem Forte
Estrogel
Estrogel (TN)
Estrogel HBF
Estrogens, esterified
Estropause
Estrovite
EU-0100503
Evamist
EvaMist (TN)
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
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
Menostar (TN)
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
PL004792
PL057607
Polyestradiol
Prestwick_207
Prestwick0_000441
Prestwick1_000441
Prestwick2_000441
Prestwick3_000441
Primofol
Profoliol
Profoliol B
progynon
Progynon DH
Progynon-DH
Progynova (TN)
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-01000075866-4
SY017569
Syndiol
Systen
Theelin, dihydro-
Tox21_111148
Tox21_202057
Tox21_300288
Tox21_500503
Tradelia
Trial SAT
Trocosone
TX-004HR
UNII-4TI98Z838E
Vagifem
Vagifem (TN)
Vivelle
Vivelle (TN)
VIVELLE-DOT
Vivelle-Dot (TN)
VOXZDWNPVJITMN-ZBRFXRBCSA-N
WLN: L E5 B666TTT&J E1 FQ OQ
Yuvvexy
Z-4415
Z1847670481
Zerella
Zesteem
Zesteen
ZINC13520815
Zumenon

Tentative approvals for ESTRADIOL

Applicant	Application No.	Strength	Dosage Form
➤ Sign Up	➤ Sign Up	1MG;2MG;2MG	TABLET;ORAL
➤ Sign Up	➤ Sign Up	3MG;2MG;3MG	TABLET;ORAL

US Patents and Regulatory Information for estradiol

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Noven	MINIVELLE	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	203752-001	Oct 29, 2012		RX	Yes	No	➤ Sign Up	➤ Sign Up	Y	Y		➤ Sign Up
Novartis	ESTRADERM	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	019081-003	Sep 10, 1986		DISCN	Yes	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Women First Hlthcare	ESCLIM	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020847-003	Aug 4, 1998		DISCN	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Lannett Holdings Inc	ESTRADIOL	estradiol	TABLET;ORAL	040138-001	Jan 30, 1998		DISCN	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	VIVELLE-DOT	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020538-007	Jan 8, 1999	➤ Sign Up	➤ Sign Up
Novartis	VIVELLE-DOT	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020538-009	May 3, 2002	➤ Sign Up	➤ Sign Up
Novartis	VIVELLE	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020323-004	Oct 28, 1994	➤ Sign Up	➤ Sign Up
Bayer Hlthcare	MENOSTAR	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	021674-001	Jun 8, 2004	➤ Sign Up	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

Non-Orange Book US Patents for estradiol

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

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Patent No.	Title	Estimated Patent Expiration
8,980,309	Transdermal testosterone formulation for minimizing skin residues	➤ Sign Up
7,387,788	Pharmaceutical compositions of nicotine and methods of use thereof	➤ Sign Up
7,404,965	Composition for transdermal and/or transmucosal administration of active compounds that ensures adequate therapeutic levels	➤ Sign Up
7,214,381	Composition for transdermal and/or transmucosal administration of active compounds that ensures adequate therapeutic levels	➤ Sign Up
Patent No.	Title	Estimated Patent Expiration

International Patents for estradiol

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Country	Document Number	Estimated Expiration
Portugal	1343508	➤ Sign Up
European Patent Office	2310001	➤ Sign Up
South Korea	20110039331	➤ Sign Up
Japan	2004513755	➤ Sign Up
Country	Document Number	Estimated Expiration

Supplementary Protection Certificates for estradiol

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Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
/2004	Austria	➤ Sign Up	PRODUCT NAME: DROSPIRENON IN KOMBINATION MIT ESTRADIOL; NAT. REGISTRATION NO/DATE: 1-25178, 1-25179 20031127; FIRST REGISTRATION: NL RVG 27505 20021211
C0018	France	➤ Sign Up	PRODUCT NAME: ESTRADIOL VALERATE; DIENOGEST; NAT. REGISTRATION NO/DATE: NL35170 20081210; FIRST REGISTRATION: BE327792 20081103
2009004	Lithuania	➤ Sign Up	PRODUCT NAME: ESTRADIOLI VALERAS + DIENOGESTUM; NAT. REGISTRATION NO/DATE: LT/1/09/1512/001, 2009 04 06 LT/1/09/1512/002, 2009 04 06 LT/1/09/1512/003 20090406; FIRST REGISTRATION: BE 327792 20081103
C/GB04/032	United Kingdom	➤ Sign Up	PRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310
Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description