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Details for Generic Name: estradiol

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Estradiol is the generic ingredient in thirty-seven branded drugs marketed by Warner Chilcott Us, Actavis Labs Ut Inc, Bayer Hlthcare, Women First Hlthcare, Novartis, Mylan Technologies, Ortho Mcneil Pharm, Parke Davis, Noven, Meda Pharms, Ascend Theraps Us, Vertical Pharms Llc, Pharmacia And Upjohn, Elan Pharma Intl Ltd, Bristol Myers Squibb, Barr Labs Inc, Heritage Pharms Inc, Lannett Holdings Inc, Mylan, Usl Pharma, Watson Labs, Duramed Pharms Barr, Novo Nordisk Inc, Warner Ireland, Warner Chilcott Llc, Medicis, Par Sterile Products, Luitpold, Sandoz, Watson Labs Inc, Savage Labs, Noven Pharms Inc, Amneal Pharms Llc, Barr, Breckenridge Pharm, Teva Pharms Usa, and Teva Womens, and is included in fifty-five NDAs. There are twenty-one patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has three hundred and twenty-three patent family members in thirty-eight countries.

There are seventy-four drug master file entries for estradiol. Sixteen suppliers are listed for this compound.

Summary for Generic Name: estradiol

Tradenames:37
Patents:21
Applicants:37
NDAs:55
Drug Master File Entries: see list74
Suppliers: see list16
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

Pharmacology for Ingredient: estradiol

Ingredient-typeEstradiol Congeners
Drug ClassEstrogen
Mechanism of ActionEstrogen Receptor Agonists

Clinical Trials for: estradiol

Serum Estradiol Levels In Postmenopausal Women With Breast Cancer Receiving Adjuvant Aromatase Inhibitors and Vaginal Estrogen
Status: Active, not recruiting Condition: Atrophic Vaginitis; Breast Cancer

Postpartum Depression: Transdermal Estradiol Versus Sertraline
Status: Terminated Condition: Postpartum Depression

Estradiol Transdermal Spray in the Treatment of Vasomotor Symptoms
Status: Completed Condition: Hot Flashes

Drug Interaction Study of Isavuconazole and Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone
Status: Completed Condition: Pharmacokinetics of Isavuconazole; Pharmacokinetics of Ethinyl Estradiol and Norethindrone; Healthy Volunteers

Perimenopausal Effects of Estradiol on Reward Responsiveness
Status: Not yet recruiting Condition: Perimenopausal Depression

A Randomized Controlled Trial of Oral Naproxen and Transdermal Estradiol for Bleeding in LNG-IUC
Status: Completed Condition: Contraception; Bleeding

MsFLASH-03: Comparative Efficacy of Low-Dose Estradiol and Venlafaxine XR for Treatment of Menopausal Symptoms
Status: Completed Condition: Hot Flashes; Menopause; Vasomotor Disturbance

Effect of Estradiol+Drospirenone Versus Estradiol+MPA on Endothelial Function
Status: Completed Condition: Cardiovascular Diseases

Efficacy and Safety of Estradiol and Progesterone Microspheres for the Treatment of Climacteric Symptoms.
Status: Completed Condition: Menopause

Postmenopausal Facial Skin After Estradiol and Genistein Topical Treatment
Status: Completed Condition: Atrophy

Estradiol/Norethindrone Acetate Tablets, 1/0.5 mg Under Fed Conditions
Status: Completed Condition: Healthy

Efficacy and Safety Of Spil's Estradiol Vaginal Tablet
Status: Recruiting Condition: Vulvar Atrophy; Vaginal Atrophy

Norethindrone/Ethinyl Estradiol 0.4 mg/35 Mcg Chewable Tablets Under Fasting Conditions
Status: Completed Condition: Bioequivalence

Drospirenone/Ethinyl Estradiol (3 mg/0.02 mg) Tablets Under Fasting Conditions.
Status: Completed Condition: Healthy

Drospirenone/Ethinyl Estradiol (3 mg/0.02 mg) Tablets Under Non-Fasting Conditions
Status: Completed Condition: Healthy

Norethindrone/Ethinyl Estradiol 0.4 mg/35 Mcg Chewable Tablets Under Non-Fasted Conditions
Status: Completed Condition: Healthy

Estradiol/Norethindrone Acetate Tablets, 1/0.5 mg Under Fasting Conditions
Status: Completed Condition: Healthy

Optimizing Ovulation Induction in the Poor Responder
Status: Withdrawn Condition: IVF Poor Responders

Vaginal Testosterone Cream vs ESTRING for Vaginal Dryness or Decreased Libido in Early Stage Breast Cancer Patients
Status: Completed Condition: Sexual Dysfunction, Physiological

Neoadjuvant Estradiol or Androgen Deprivation in Clinically Localized Prostate Cancer
Status: Completed Condition: Cancer; Prostate Neoplasms

Pharmacokinetics of Injectable Estradiol and Progesterone Microspheres Suspension
Status: Completed Condition: Menopause

Study of Physiological and High Dose Estradiol in the Treatment of Hormone Receptor Positive Metastatic Breast Cancer
Status: Completed Condition: Breast Neoplasms

Concomitant Clomiphene and Estradiol Versus Clomiphene Alone in Ovulation Induction
Status: Active, not recruiting Condition: Anovulation

Estradiol Levels in Patients Treated With Estring
Status: Recruiting Condition: Estrogen Levels Among Breast Cancer Patients

Pharmacodynamics of NPC-01/IKH-01; Effect of NPC-01/IKH-01 on Sexual Hormone Concentrations in Healthy Female Volunteers
Status: Completed Condition: Healthy

Study to Evaluate the Safety and Bioequivalence of Estradiol Vaginal Inserts, 10 mcg and Vagifem® 10 mcg and Compare to Placebo
Status: Completed Condition: Atrophic Vaginitis Due to Menopause

Vascular Effect of Estradiol Valerate Versus Placebo Evaluated by Flow-mediated Dilatation of Brachial Artery
Status: Recruiting Condition: Flow-mediated Dilation Evaluation of the Brachial Artery

Initiating Transdermal Estradiol Therapy in Turner's Syndrome
Status: Terminated Condition: Turner's Syndrome

ELITE: Early Versus Late Intervention Trial With Estradiol
Status: Active, not recruiting Condition: Atherosclerosis

Oral Contraceptive Ethinyl Estradiol Dose Effect on Postpartum Depression and Sexual Functioning Scales
Status: Recruiting Condition: Postpartum Depressive Mood; Postpartum Sexual Function

Therapeutic Estradiol and Exemestane in Treating Post-Menopausal Patients With Hormone Receptor-Positive Metastatic Breast Cancer
Status: Active, not recruiting Condition: Estrogen Receptor-positive Breast Cancer; Progesterone Receptor-positive Breast Cancer; Recurrent Breast Cancer; Stage IIIC Breast Cancer; Stage IV Breast Cancer

Pretreatment With Estradiol Valerate
Status: Completed Condition: Infertility

POPART'MUS: Prevention of Post Partum Relapses With Progestin and Estradiol in Multiple Sclerosis
Status: Active, not recruiting Condition: Multiple Sclerosis

Estradiol and Testosterone Levels in Seminal Plasma of Men With Non-obstructive Azoospermia
Status: Completed Condition: Non-obstructive Azoospermia With Testicular Biopsy for Spermatozoa Extraction

A Comparison of Estradiol Vaginal Cream to Estrace® Cream in 350 Postmenopausal Females With Atrophic Vaginitis
Status: Completed Condition: Atrophic Vaginitis

Effect of 17ß-estradiol on Inflammatory-immune Responses in Post-menopausal Women According to Administration Route
Status: Completed Condition: Postmenopausal

Oestradiol Pre-treatment in an Ultrashort Flare GnRH Agonist/GnRH Antagonist Protocol in Poor Responders Undergoing IVF
Status: Recruiting Condition: Infertility

Estradiol vs Lysteda in Treatment of Heavy Menstrual Bleeding
Status: Recruiting Condition: Menstrual Cycle and Uterine Bleeding Disorders

Drug Interaction Study of an OCP (Norethindrone (ND) Acetate and Ethinyl Estradiol (EE))With a Combination of Daclatasvir (DCV) Asunaprevir (ASV) and BMS-791325
Status: Completed Condition: Hepatitis C

Duragen Versus Duraguard in Chiari Surgery
Status: Completed Condition: Chiari Malformation

Research Investigation of Soy and Estrogen
Status: Recruiting Condition: Menopause; Hot Flashes

Pharmacokinetics of NPC-01 After Single Oral Administration in Healthy Female Volunteers
Status: Completed Condition: Healthy

The Effect of Ethinyl Estradiol on Polycystic Ovary Syndrome Women Undergoing Intrauterine Insemination
Status: Completed Condition: Infertility

Dose Effects of Hormone Therapy (Two Doses of Estradiol Associated to Progesterone) on Inflammatory Markers
Status: Terminated Condition: Healthy Symptomatic Menopausal Women

Paclitaxel Poliglumex and Estradiol in Treating Patients With Stage IV Prostate Cancer
Status: Terminated Condition: Prostate Cancer

Evaluation of Adhesion Quality and Irritation of an Alternate Second Generation Estradiol Transdermal System
Status: Completed Condition: Healthy

Pilot Study of Femring Estrogen Supplementation During Depo-Provera Initiation
Status: Completed Condition: Metrorrhagia

An Open-label Study to Evaluate Contraceptive Efficacy and Safety of the Transdermal Contraceptive System of Norelgestromine and Ethinyl Estradiol
Status: Completed Condition: Contraception

ZK283197 for Treatment of Vasomotor Symptoms
Status: Completed Condition: Vasomotor System

Maintenance Suppression of Testosterone With Transdermal Estradiol Gel
Status: Not yet recruiting Condition: Cancer of the Prostate

A Bioequivalence Study of Norgestimate /Ethinyl Estradiol (NGM/EE) Tablets Manufactured at 2 Different Facilities
Status: Completed Condition: Healthy

Prevention of Menstrual Migraines: Effects of Estrogen Add-back During the HFI in Patients Using Continuous Oral Contraceptives.
Status: Recruiting Condition: Menstrual Migraines; Menstrual Bleeding; Menstrual Spotting

Acute Metabolic Effects of Estradiol
Status: Completed Condition: Postmenopause

Ethinyl Estradiol and Cyproterone Acetate in Irregular Menstruation
Status: Active, not recruiting Condition: Amenorrhea; Dysmenorrhea; Menstruation Disturbances; Hyperandrogenism

Antral Follicle Priming Prior to ICSI (Intracytoplasmic Sperm Injection) in Previously Diagnosed Low Responders
Status: Completed Condition: Ovarian Diseases

A Safety and Efficacy Study of the Combination Estradiol and Progesterone to Treat Vasomotor Symptoms
Status: Recruiting Condition: Menopause

Phytoestrogens as an Alternative to Estradiol in Ovulation Induction in PCOS
Status: Completed Condition: Polycystic Ovaries

Effects of Anorexia Nervosa on Peak Bone Mass
Status: Recruiting Condition: Anorexia Nervosa

Study to Evaluate the Pharmacokinetics of an Oral Contraceptive Containing Levonorgestrel and Ethinyl Estradiol When Co-administered With GSK1265744 in Healthy Adult Female Subjects
Status: Completed Condition: Infections, Human Immunodeficiency Virus and Hepatitis

Estrogen Dosing in Turner Syndrome: Pharmacology and Metabolism
Status: Completed Condition: Turner Syndrome; Hypogonadism; Premature Ovarian Failure

Evaluation of Adhesion Quality of a New Formulation of the Mylan Estradiol Transdermal System 0.025 mg/Day and Climara® Transdermal System 0.025 mg/Day
Status: Completed Condition: Healthy

Clinical Estradiol Trial in Women With Schizophrenia
Status: Completed Condition: Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder

Phase II Trial of Transdermal Estradiol for Hormone Refractory Prostate Cancer
Status: Terminated Condition: Prostate Cancer

Effect of Oral Estradiol and Progesterone Therapy on Vaginal Cytokines in Postmenopausal Women
Status: Not yet recruiting Condition: Menopause

Timing of Estrogen Support During the Luteal Phase of in Vitro Fertilization (IVF)/Intracytoplasmic Sperm Injection (ICSI) Cycle
Status: Completed Condition: Infertility

Observational Study to Investigate the Occurrence of Bleeding in Postmenopausal Women Treated With Estradiol/NETA for 12 Months
Status: Completed Condition: Menopause; Postmenopausal Bleeding

A Trial to Evaluate the Efficacy of Low Dose Vaginal Estrogens in the Treatment of Atrophic Vaginitis
Status: Terminated Condition: Atrophic Vaginitis

The Influence of Estradiol Supplementation During the Luteal in Patients Undergoing IVF Treatment
Status: Not yet recruiting Condition: Infertility

Study Comparing 17B Estradiol/TMG CC 1mg Vs. Tibolone In Postmenopausal Women
Status: Completed Condition: Vasomotor Symptoms

Effect of Two Different Dosages of Ethinyl-estradiol in Association With Drospirenone in Women With Polycystic Ovary Syndrome.
Status: Completed Condition: Polycystic Ovary Syndrome; Estro-progestin Drugs

Vasomotoric Symptoms Study of a 0.5 mg Estradiol and 2.5 mg Dydrogesterone Combination
Status: Completed Condition: Postmenopause

Study of the Effect of Testosterone and Estradiol on NP Responses to Acute and Chronic Salt Loading
Status: Withdrawn Condition: Hypertension

Study Evaluating Estradiol/Trimegestone in Vasomotor Symptoms (VMS) in Post-Menopausal Women.
Status: Completed Condition: Postmenopause

Study Evaluating Effects of Levonorgestrel and Ethinyl Estradiol on Ovulation
Status: Completed Condition: Ovulation

Role of Pregnancy Related Hormones in Lowering the Insulin Requirement in Pregnant Women With Type 1 Diabetes
Status: Not yet recruiting Condition: Type 1 Diabetes

A Definitive Estrogen Patch Study (ADEPT)
Status: Completed Condition: Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder(Not in Manic Phase)

A Pharmacokinetic Study of Colchicine With an Oral Contraceptive
Status: Completed Condition: Pharmacokinetics

Endometrial Safety of a Low Dose of Vagifem® in Postmenopausal Women With Atrophic Vaginitis
Status: Completed Condition: Menopause; Postmenopausal Vaginal Atrophy

Hormone Replacement Therapy for Use in Postmenopausal Women for Relief of Hot Flushes and Urogenital Symptoms.
Status: Completed Condition: Hormone Replacement Therapy

Effects of Estradiol on Menopausal Breast
Status: Recruiting Condition: Hormone Replacement Therapy

Clinical, Metabolic and Endocrine Effects of the Treatment With Drospirenone and Ethinyl Estradiol Alone or in Combination With Myo-inositol in Young Women With Polycystic Ovary Syndrome (PCOS) and Insulin Resistance
Status: Completed Condition: PCOS; Polycystic Ovary Syndrome

Comparison of Two Vaginal Tablets, Produced at Different Sites, in Postmenopausal Women With Atrophic Vaginitis
Status: Completed Condition: Menopause; Postmenopausal Vaginal Atrophy

ER Reactivation Therapy for Breast Cancer
Status: Active, not recruiting Condition: Metastatic Breast Cancer

Study Evaluating Levonorgestrel and Ethinyl Estradiol for Oral Contraception
Status: Recruiting Condition: Oral Contraceptive

Safety/Efficacy Study of Drospirenone/Estradiol to Treat Postmenopausal Chinese Women With Vasomotor Symptoms.
Status: Completed Condition: Vasomotor Symptoms

An Open-Label Study to Compare the Bleeding Profile of Norelgestromin/Ethinyl Estradiol in an Extended Regimen to Norelgestromin/Ethinyl Estradiol Given in a Traditional Regimen
Status: Completed Condition: Metrorrhagia

Safety and Efficacy Of Drospirenone and Ethinyl Estradiol vs Placebo in the Treatment of Truncal Acne
Status: Completed Condition: Acne Vulgaris

Estradiol Vaginal Softgel Capsules in Treating Symptoms of Vulvar and Vaginal Atrophy in Postmenopausal Women
Status: Recruiting Condition: Vulvovaginal Atrophy; Menopause; Dyspareunia; Painful Intercourse

Hysteroscopy After Pretreatment With Misoprostol and Estradiol Trial
Status: Completed Condition: Cervical Ripening

An Efficacy and Safety Study Comparing Oral Contraceptive Containing Norgestimate or Desogestrel for Acne Treatment
Status: Completed Condition: Acne Vulgaris

Efficacy and Safety of 17-Beta Estradiol in Treatment of Atrophic Vaginitis
Status: Completed Condition: Menopause; Postmenopausal Vaginal Atrophy

A Study to See Whether Estrogen Can Slow the Growth of Some ER Positive Breast Cancers
Status: Not yet recruiting Condition: ER+ Breast Cancer

Pharmacokinetic Assessment of the Absorption of Estradiol in Postmenopausal Women With Atrophic Vaginitis
Status: Completed Condition: Menopause; Postmenopausal Vaginal Atrophy

Insulin Resistance, Polycystic Ovary Syndrome, and Bone Research Study
Status: Active, not recruiting Condition: Polycystic Ovary Syndrome

A Study to Assess the Effects of Canagliflozin (JNJ-28431754) on the Pharmacokinetics and Safety of an Oral Contraceptive in Healthy Volunteers
Status: Completed Condition: Healthy

Bioequivalence Study: 3 mg Estradiol Valerate (EV) With and Without Levomefolate Calcium
Status: Completed Condition: Contraception; Ovulation Inhibition

Perimenopausal Estrogen Replacement Therapy Study
Status: Active, not recruiting Condition: Perimenopause; Menopause; Depression

A Study to Evaluate the Exposure of Norelgestromin and Ethinyl Estradiol From Commercial Lots of EVRA (a Transdermal Contraceptive Patch Manufactured by LOHMANN Therapie-Systeme) and CILEST (an Oral Contraceptive)
Status: Completed Condition: Contraception; Female Contraception

Clinical Trial of Estrogen for Postpartum Depression
Status: Recruiting Condition: Postpartum Depression; Depression

Effect of the Etonogestrel 0.12mg/Ethinyl Estradiol 0.015mg Vaginal Ring on Vaginal Innate and Inflammatory Biomarkers
Status: Recruiting Condition: Vaginosis, Bacterial

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal Pharms Llc
ACTIVELLA
estradiol; norethindrone acetate
TABLET;ORAL020907-002Dec 28, 2006RXNo<disabled><disabled>
Ascend Theraps Us
ESTROGEL
estradiol
GEL, METERED;TRANSDERMAL021166-002Feb 9, 2004RXYes<disabled><disabled>
Novo Nordisk Inc
INNOFEM
estradiol
TABLET;ORAL040312-003Nov 19, 1999DISCNNo<disabled><disabled>
Usl Pharma
ESTRADIOL
estradiol
TABLET;ORAL040297-002Apr 17, 2002RXNo<disabled><disabled>
Novo Nordisk Inc
INNOFEM
estradiol
TABLET;ORAL040312-001Nov 19, 1999DISCNNo<disabled><disabled>
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International Patent Family for Ingredient: estradiol

Country Document Number Publication Date
Argentina030312Aug 20, 2003
Australia5258999Dec 02, 1999
Australia706967Jul 01, 1999
Australia2004283431May 06, 2005
AustraliaPN814496Mar 14, 1996
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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