Competitive intelligence on 
 small-molecule drugs and 
 the 90,000 global patents 
 covering them 

Start your free trial now

DrugPatentWatch Ultimate Plan Preview

Details for Generic Name: estradiol

« Back to Dashboard

Estradiol is the generic ingredient in thirty-seven branded drugs marketed by Warner Chilcott Us, Watson Labs, 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, Lumara Health Inc, Bristol Myers Squibb, Aai Pharma Inc, Barr Labs Inc, Heritage Pharms Inc, Mylan, Usl Pharma, Duramed Pharms Barr, Novo Nordisk Inc, Warner Ireland, Warner Chilcott Llc, Medicis, Par Sterile Products, Luitpold, Sandoz, Watson Labs Inc, Savage Labs, Amneal Pharms Llc, Barr, Breckenridge Pharm, Teva Pharms Usa, and Teva Womens, and is included in fifty-four NDAs. There are twenty-two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are seventy-three drug master file entries for estradiol. Fourteen suppliers are listed for this compound.

Summary for Generic Name: estradiol

Drug Master File Entries: see list73
Suppliers: see list14
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)

Pharmacology for Ingredient: estradiol

Ingredient-typeEstradiol Congeners
Drug ClassEstrogen
Mechanism of ActionEstrogen Receptor Agonists

Clinical Trials for: estradiol

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Assessment of Sensitivity of the Hypothalamic GnRH Pulse Generator to Estradiol and Progesterone Inhibition
Status: Recruiting Condition: Hyperandrogenemia; Polycystic Ovary Syndrome

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

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

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

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

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

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

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

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

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

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

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

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

Acute Metabolic Effects of Estradiol
Status: Completed Condition: Postmenopause

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

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

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

A Study of the Effect of Estrogen on Estrogen Receptor Biomarkers in Healthy Postmenopausal Women (0000-094)(COMPLETED)
Status: Completed Condition: Postmenopause

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

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

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

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

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

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

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

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

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

A Clinical Study to Evaluate the Effects of Estrogen in Healthy Postmenopausal Women
Status: Completed Condition: Postmenopausal Symptoms

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

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

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

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

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

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

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

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

Effects of Androgen Blockade on Sensitivity of the GnRH Pulse Generator to Suppression by Estradiol and Progesterone
Status: Active, not recruiting Condition: Polycystic Ovary Syndrome; Hyperandrogenism

Effect of Metformin on Sensitivity of the Gonadotropin-releasing Hormone (GnRH) Pulse Generator to Suppression by Estradiol and Progesterone
Status: Recruiting Condition: Polycystic Ovary Syndrome; Hyperandrogenism

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

DuraGen Plus® Adhesion Barrier for Use in Spinal Surgery
Status: Terminated Condition: Spinal Injuries; Adhesions

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

Detrol LA vs Estrace Vaginal Cream for the Treatment of Overactive Bladder Symptoms
Status: Completed Condition: Overactive Bladder

Comparison of Two Vaginal Tablets, Produced at Different Sites, 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

ER Reactivation Therapy for Breast Cancer
Status: Not yet recruiting Condition: Metastatic Breast Cancer

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

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

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

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, 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

Perimenopausal Estrogen Replacement Therapy Study
Status: Recruiting Condition: Perimenopause; Menopause; Depression

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

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

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

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

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

Relationship Between the Menstrual Cycle and Heart Disease in Women
Status: Completed Condition: Coronary Heart Disease

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

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

Courtesy of
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
estradiol; norethindrone acetate
FILM, EXTENDED RELEASE;TRANSDERMAL020870Aug 7, 1998RXYes6,024,976<disabled><disabled>
Teva Womens
estradiol; norgestimate
TABLET;ORAL021040Oct 22, 1999DISCNNo7,320,970<disabled>Y<disabled>
Bristol Myers Squibb
TABLET;ORAL084500Approved Prior to Jan 1, 1982DISCNNo<disabled><disabled>
Breckenridge Pharm
estradiol; norethindrone acetate
TABLET;ORAL078324Apr 17, 2008RXNo<disabled><disabled>
FILM, EXTENDED RELEASE;TRANSDERMAL019081Sep 10, 1986RXNo<disabled><disabled>
This preview shows a limited data set
Subscribe for full access, or try a free trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

DrugPatentWatch Archives

You are viewing the current data set
Select a link below to view the archives:

 2000   2001   2002   2003   2004   2005   2006   2007   2008   2009   2010   2011   2012   2013  

For more information try a free trial or see the plan comparison

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Connect with Social Media:

Follow DrugPatentWatch on Twitter Connect with DrugPatentWatch on Linkedin Drug Patents on LinkedIn

Copyright © 2002-2014 thinkBiotech LLC. ISSN: 2162-2639

Other thinkBiotech sites: PatentStatBiotechBlogJournal of Commercial Biotechnology