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Last Updated: December 14, 2019

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Estrogens, conjugated - Generic Drug Details

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

Estrogens, conjugated is the generic ingredient in twelve branded drugs marketed by Wyeth Pharms, Teva Womens, Aspen, Wyeth Pharms Inc, Medpointe Pharm Hlc, and Wyeth Ayerst, and is included in ten NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for estrogens, conjugated. Two suppliers are listed for this compound.

Recent Clinical Trials for estrogens, conjugated

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

SponsorPhase
Emory UniversityPhase 4
Women and Infants Hospital of Rhode IslandPhase 4
University of Texas Southwestern Medical CenterPhase 4

See all estrogens, conjugated clinical trials

Pharmacology for estrogens, conjugated
Drug ClassEstrogen
Mechanism of ActionEstrogen Receptor Agonists
Synonyms for estrogens, conjugated
16680-47-0
17-Oxoestra-1,3,5(10),7-tetraen-3-yl sodium sulfate
27540-07-4 (Parent)
3-(Sulfooxy)estra-1,3,5(10),7-tetraen-17-one Sodium Salt
3-Hydroxyestra-1,3,5(10),7-tetraen-17-one Hydrogen Sulfate Sodium Salt
7XY8FW3E68
AKOS027322958
Ayerogen
Ayerogen Crema Vaginal
Azumon
C.E.S
C13416
CCRIS 7207
CEE
Cenestin
CHEBI:32143
Climarest
Climatrol
Climestrone
Climopax
CO-Estro
Conest
Conestron
Conjes
Conjugated equine estrogen
Conjugated estrogenic hormones
Conjugated estrogens: sodium equilin sulfate
Conjugen
Conjutabs
Dagynil
DTXSID00872961
EINECS 235-199-5
EINECS 240-727-2
Emopremarin
Equigyne
Equilin 3-Sulfate Sodium Salt
Equilin sodium sulfate
Equilin, sulfate, sodium salt (6CI)
Equin
Estra-1,3,5(10),7-tetraen-17-one, 3-(sulfooxy)-, sodium salt
Estra-1,3,5(10),7-tetraen-17-one, 3-hydroxy-, hydrogen sulfate sodium salt (8CI)
Estra-1,3,5(10),7-tetraen-17-one,3-(sulfooxy)-,sodium salt
Estratab
Estrifol
Estroate
Estrocon
Estrogenic substances, cojugated
Estrogenic substances, conjugated
Estrogens conjugated [USP]
Estrogens, conjugated [USP:JAN]
Estrogens, conjugated [USP]
Estrogens, conjugates
Estromed
Estropan
FEM H
Femacoid
Femavit
Femest
Formatrix
Ganeake
Genisis
Glyestrin
HSDB 3076
Hyphorin
J-004475
Kestrin
LS-2303
Mannest
Menogen
Menopak-E
Menoprem Continuous
Menotab
Menotrol
Menpoz
Msmed
Neo-Menovar
Novoconestron
Oestrilin
Oestro-feminal
Oestropak morning
Ovest
Palopause
Premaril
Premaril Plus
PREMARIN (EQUILIN)
Premarin Crema V
Premarin Creme
Premarin Vaginal Creme
Premarina
Premarose
Prempak
Presomen
Prevagin-Premaril
Primarin
Promarit
Provette Continuous
Romeda
SCHEMBL974791
Sefac
Sodestrin-H
Sodium (9S,13S,14S)-13-methyl-17-oxo-9,11,12,13,14,15,16,17-octahydro-6H-cyclopenta[a]phenanthren-3-yl sulfate
sodium 17-oxoestra-1(10),2,4,7-tetraen-3-yl sulfate
Sodium equilin 3-monosulfate
Sodium equilin sulfate
Sodium estrone sulfate, mixted with sodium equilin sulfate
Srogen
Sukingpo
TAG-39
Theogen
Transannon
UNII-3ASP8Q3768 component QTTMOCOWZLSYSV-QWAPEVOJSA-M
UNII-7XY8FW3E68
UNII-8L6LAK9BTR component QTTMOCOWZLSYSV-QWAPEVOJSA-M
UNII-IU5QR144QX component QTTMOCOWZLSYSV-QWAPEVOJSA-M
UNII-JM2621P2LS component QTTMOCOWZLSYSV-QWAPEVOJSA-M
Zeste
Paragraph IV (Patent) Challenges for ESTROGENS, CONJUGATED
Tradename Dosage Ingredient NDA Submissiondate
PREMARIN TABLET;ORAL estrogens, conjugated 004782

US Patents and Regulatory Information for estrogens, conjugated

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aspen CENESTIN estrogens, conjugated synthetic a TABLET;ORAL 020992-002 Mar 24, 1999 DISCN Yes No   Start Trial   Start Trial   Start Trial
Aspen ENJUVIA estrogens, conjugated synthetic b TABLET;ORAL 021443-001 Dec 20, 2004 DISCN No No   Start Trial   Start Trial Y Y   Start Trial
Wyeth Pharms Inc PREMPHASE (PREMARIN;CYCRIN 14/14) estrogens, conjugated; medroxyprogesterone acetate TABLET;ORAL-28 020303-002 Dec 30, 1994 DISCN No No   Start Trial   Start Trial   Start Trial
Aspen CENESTIN estrogens, conjugated synthetic a TABLET;ORAL 020992-003 Mar 24, 1999 DISCN Yes No   Start Trial   Start Trial   Start Trial
Wyeth Pharms PREMPHASE 14/14 estrogens, conjugated; medroxyprogesterone acetate TABLET;ORAL-28 020527-002 Nov 17, 1995 RX Yes Yes   Start Trial   Start Trial   Start Trial
Wyeth Ayerst PMB 400 estrogens, conjugated; meprobamate TABLET;ORAL 010971-003 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Wyeth Pharms PREMARIN estrogens, conjugated TABLET;ORAL 004782-003 Approved Prior to Jan 1, 1982 RX Yes 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 estrogens, conjugated

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Wyeth Pharms PREMARIN estrogens, conjugated TABLET;ORAL 004782-002 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Wyeth Pharms PREMARIN estrogens, conjugated CREAM;TOPICAL, VAGINAL 020216-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Wyeth Pharms PREMARIN estrogens, conjugated TABLET;ORAL 004782-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Wyeth Pharms PREMARIN estrogens, conjugated TABLET;ORAL 004782-004 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Wyeth Pharms PREMARIN estrogens, conjugated TABLET;ORAL 004782-005 Jan 26, 1984   Start Trial   Start Trial
Wyeth Pharms PREMARIN estrogens, conjugated TABLET;ORAL 004782-003 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Wyeth Pharms PREMARIN estrogens, conjugated INJECTABLE;INJECTION 010402-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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