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Last Updated: March 1, 2021

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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 patent protection?

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
St. Joseph's Healthcare HamiltonPhase 1
McMaster UniversityPhase 1
Emory UniversityPhase 4

See all estrogens, conjugated clinical trials

Pharmacology for estrogens, conjugated
Drug ClassEstrogen
Mechanism of ActionEstrogen Receptor Agonists
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 ENJUVIA estrogens, conjugated synthetic b TABLET;ORAL 021443-004 May 10, 2004 DISCN No No   Start Trial   Start Trial Y Y   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
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 PREMPRO estrogens, conjugated; medroxyprogesterone acetate TABLET;ORAL-28 020527-005 Jun 4, 2003 RX Yes Yes   Start Trial   Start Trial   Start Trial
Teva Womens SYNTHETIC CONJUGATED ESTROGENS A estrogens, conjugated synthetic a CREAM;VAGINAL 021788-001 Nov 28, 2008 DISCN No No   Start Trial   Start Trial   Start Trial
Aspen ENJUVIA estrogens, conjugated synthetic b TABLET;ORAL 021443-005 Apr 27, 2007 DISCN No No   Start Trial   Start Trial Y Y   Start Trial
Aspen ENJUVIA estrogens, conjugated synthetic b TABLET;ORAL 021443-003 May 10, 2004 DISCN No No   Start Trial   Start Trial Y Y   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 CREAM;TOPICAL, VAGINAL 020216-001 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 004782-001 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
Wyeth Pharms PREMARIN estrogens, conjugated TABLET;ORAL 004782-003 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 004782-002 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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