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Last Updated: August 7, 2020

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Estradiol cypionate - Generic Drug Details

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

Estradiol cypionate is the generic ingredient in five branded drugs marketed by Pharmacia And Upjohn, Dr Reddys, and Watson Labs, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

There are seventy-five drug master file entries for estradiol cypionate. One supplier is listed for this compound.

Recent Clinical Trials for estradiol cypionate

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

SponsorPhase
Biolab Sanus FarmaceuticaPhase 1
Galeno Desenvolvimento de Pesquisas ClínicasPhase 1
Sidney Kimmel Comprehensive Cancer CenterPhase 2

See all estradiol cypionate clinical trials

Pharmacology for estradiol cypionate
Drug ClassEstrogen
Mechanism of ActionEstrogen Receptor Agonists

US Patents and Regulatory Information for estradiol cypionate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pharmacia And Upjohn LUNELLE estradiol cypionate; medroxyprogesterone acetate INJECTABLE;INTRAMUSCULAR 020874-001 Oct 5, 2000 DISCN No No   Start Trial   Start Trial   Start Trial
Watson Labs TESTOSTERONE CYPIONATE-ESTRADIOL CYPIONATE estradiol cypionate; testosterone cypionate INJECTABLE;INJECTION 085603-001 Mar 13, 1986 DISCN No No   Start Trial   Start Trial   Start Trial
Dr Reddys ESTRADIOL CYPIONATE estradiol cypionate INJECTABLE;INJECTION 085620-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Pharmacia And Upjohn DEPO-ESTRADIOL estradiol cypionate INJECTABLE;INJECTION 085470-002 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Pharmacia And Upjohn DEPO-ESTRADIOL estradiol cypionate INJECTABLE;INJECTION 085470-003 Approved Prior to Jan 1, 1982 RX No Yes   Start Trial   Start Trial   Start Trial
Pharmacia And Upjohn DEPO-TESTADIOL estradiol cypionate; testosterone cypionate INJECTABLE;INJECTION 017968-001 Approved Prior to Jan 1, 1982 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

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Johnson and Johnson
Medtronic
Moodys
Harvard Business School
McKesson

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