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Details for Generic Name: progesterone

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Progesterone is the generic ingredient in five branded drugs marketed by Banner Life Sciences, Sofgen Pharms, Teva Pharms, Abbvie Inc, Actavis Labs Ut Inc, Fresenius Kabi Usa, Hikma Farmaceutica, Lilly, Luitpold, Watson Labs (utah), Alza, and Ferring, and is included in twelve NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has eleven patent family members in nine countries.

There are forty-seven drug master file entries for progesterone. Eight suppliers are listed for this compound.

Summary for Generic Name: progesterone

Tradenames:5
Patents:3
Applicants:12
NDAs:12
Drug Master File Entries: see list47
Suppliers: see list8
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

Pharmacology for Ingredient: progesterone

Ingredient-typeProgesterone
Drug ClassProgesterone

Clinical Trials for: progesterone

Uterine Electrical Activity Before and After Progesterone Treatment for Preterm Labor
Status: Recruiting Condition: Preterm Labor

Vaginal Compared to Intramuscular Progesterone for Frozen Embryo Transfer
Status: Not yet recruiting Condition: Infertility

Comparing IM vs. Vaginal Progesterone for Pre-term Birth
Status: Completed Condition: Infant, Premature; Premature Birth

Comparison of Crinone 8% Intravaginal Gel and IM Progesterone Supplementation for In Vitro Fertilization (IVF)
Status: Completed Condition: Infertility

Optimal Length of Progesterone Supplementation Before the Transfer of Cryopreserved (Frozen)-Thawed Day 3 Embryos in an Artificial Cycle With Exogenous Estrogen and Progesterone
Status: Recruiting Condition: Progesterone Supplementation

Vaginal Compared With Intramuscular Progesterone for Prevention of Preterm Birth in High Risk Pregnant Women
Status: Not yet recruiting Condition: Premature Birth

Sexual Absorption of Vaginal Progesterone
Status: Completed Condition: Infertility; Pregnancy

Compare the Difference of P4 Concentration in Serum and Endometrium After Vaginal and IM P Administration
Status: Completed Condition: Postmenopausal Endometrium

A Study Using Micronised Progesterone (Crinone® 8%) in the Luteal Phase Support of Women Undergoing in Vitro Fertilisation (IVF) and Embryo Transfer (ET)
Status: Completed Condition: Infertility

Progesterone and Brain Imaging Study
Status: Recruiting Condition: Nicotine Dependence; Nicotine Withdrawal

Progesterone Serum Levels in Subfertile Female Patients Undergoing in Vitro Fertilisation (IVF)
Status: Completed Condition: Infertility

Efficacy and Tolerability Study of Progesterone Vaginal Tablets (Endometrin®) in Menopausal Women Treated by Estrogen
Status: Not yet recruiting Condition: Endometrial Hyperplasia; Endometrial Cancer

Oral Progesterone for Prevention of Preterm Birth
Status: Completed Condition: Preterm Birth

Vaginal Progesterone for Prevention of Preterm Birth After an Episode of Preterm Labor
Status: Recruiting Condition: Preterm Birth

Preconceptional Progesterone Treatment in Women With Unexplained Recurrent Miscarriage, a Randomized Double-blind Controlled Trial
Status: Completed Condition: Abortion, Habitual

Efficacy Study of a Cervical Pessary Containing Progesterone for the Prevention of Preterm Delivery
Status: Recruiting Condition: Premature Birth; Fetal Membranes, Premature Rupture

Vaginal Progesterone for Prevention of Preterm Labor in Asymptomatic Twin Pregnancies With Sonographic Short Cervix
Status: Completed Condition: Premature Labour

Influence of Progesterone Administration on Drug-Induced QT Interval Lengthening
Status: Completed Condition: Prolonged QT Interval in EKG and Sudden Death

Time Course of Waking Versus Sleep-associated Luteinizing Hormone (LH) Pulse Frequency Suppression in Response to Progesterone in Late Pubertal Girls With and Without Hyperandrogenemia
Status: Recruiting Condition: Hyperandrogenemia

Progesterone for Postpartum Smokers
Status: Recruiting Condition: Tobacco Use Disorder

Oral Micronized Progesterone for Perimenopausal Vasomotor Symptoms
Status: Recruiting Condition: Hot Flushes; Night Sweats

Does Progesterone Prevent Very Preterm Delivery in Twin Pregnancies?
Status: Completed Condition: Preterm Delivery

Progesterone Treatment for Cocaine-dependent Women: A Pilot Study
Status: Completed Condition: Cocaine Dependence

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

Progesterone Support of FET
Status: Completed Condition: Frozen Embryo Pregnancy Rate

Randomized Trial of Maternal Progesterone Therapy
Status: Recruiting Condition: Congenital Heart Disease; Periventricular Leucomalacia; Brain Development; Cardiac Surgery; Neurodevelopmental Disability; Fetal Neuroprotection

Evaluating the Roles of Estrogen and Progesterone in Heart Metabolism
Status: Completed Condition: Postmenopause

Vaginal Progesterone as a Treatment for Women Active Preterm Labor
Status: Withdrawn Condition: Labor, Premature

Progesterone Microspheres Pharmacokinetic - Pharmacodynamic (PK-PD) Study
Status: Completed Condition: Infertility

Progesterone vs Placebo Therapy for Women With Epilepsy
Status: Completed Condition: Epilepsy

Efficacy and Safety Study of Intravenous Progesterone in Patients With Severe Traumatic Brain Injury
Status: Completed Condition: Brain Injuries

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

Progesterone Supplementation for HIV-positive Pregnant Women on Anti-Retrovirals
Status: Not yet recruiting Condition: HIV-1 Infection

Prophylactic Administration of Natural Progesterone in the Prevention of Preterm Delivery in Twin Pregnancies
Status: Completed Condition: Preterm Delivery

Randomized Controlled Trial of Vaginal Progesterone in Women With Threatened Preterm Labor
Status: Terminated Condition: Obstetric Labor, Premature

Early Progesterone Cessation After in Vitro Fertilization
Status: Completed Condition: All Patients Which Show a Gestational Sac in Their Uterus in the First US Are Included in This Study and Randomized.

Progesterone Effect on Individuals Diagnoses With AD and PTSD.
Status: Not yet recruiting Condition: Alcohol Dependence; Post-Traumatic Stress Disorder (PTSD)

Vaginal Progesterone to Prevent Preterm Delivery in Women With Preterm Labor
Status: Terminated Condition: Preterm Delivery; Morbidity; Perinatal Mortality

Subcutaneous Progesterone Versus Vaginal Progesterone for Endometrial Preparation in Fresh Donated Oocytes Recipients
Status: Not yet recruiting Condition: Infertility

Progesterone for Postpartum Cocaine Relapse
Status: Completed Condition: Cocaine Abuse; Cocaine Dependence; Postpartum Period

Randomized Controlled Trial of Neo-adjuvant Progesterone and Vitamin D3 in Women With Large Operable Breast Cancer and Locally Advanced Breast Cancer
Status: Recruiting Condition: Locally Advanced Breast Cancer and Large Operable Breast Cancer

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

A Prospective Randomized Multicentre Study to Compare Crinone 8% Once Daily Versus Other Vaginal Progesterone.
Status: Recruiting Condition: IVF - Luteal Phase Support After Embryo Transfer

Luteal Phase Support With Progesterone Versus Estrogen and Progesterone on Pregnancy Rates
Status: Not yet recruiting Condition: Unexplained Infertility; Mild Male Factor

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

Progesterone and Atomoxetine for Cocaine Cessation
Status: Not yet recruiting Condition: Cocaine Addiction; Smoking Addiction

Natural Progesterone and Preterm Birth in Twins
Status: Completed Condition: Preterm Birth

Vaginal Progesterone in the Treatment of Cervical Dysplasia Grade I and II
Status: Completed Condition: Cervical Intraepithelial Neoplasia

Does Oral Micronized Progesterone Shorten Time of Symptoms From Concussion
Status: Active, not recruiting Condition: Concussion

Vaginal Progesterone for the Prevention of Preterm Birth in Women With Arrested Preterm Labor
Status: Recruiting Condition: Premature Birth; Obstetric Labor, Premature

Primary Progesterone Therapy for Operable Breast Cancer
Status: Active, not recruiting Condition: Breast Neoplasms

Vaginal Progesterone Versus Progesterone in Oil in Donor Egg Recipient In Vitro Fertilization Cycles Utilizing Vitrified Donor Eggs
Status: Completed Condition: Infertility

Effect of Progesterone on Smoking Behavior in Male and Female Smokers
Status: Completed Condition: Tobacco Use Disorder

Progesterone and Second Trimester Bleeding
Status: Recruiting Condition: Antepartum Bleeding; Preterm Birth

Oral Progesterone and Low Dose Aspirin in the Prevention of Preeclampsia
Status: Terminated Condition: Preeclampsia

Subcutaneous Progesterone Versus Vaginal Progesterone Gel for Luteal Phase Support
Status: Recruiting Condition: Infertility

Cut-Off Progesterone Values Deleterious for In Vitro Fertilization and Fresh Embryo Transfer
Status: Completed Condition: Progesterone; Fertilization in Vitro; Infertility; Pregnancy

Uterine Contractions and Mode of Progesterone in Frozen Embryo Transfer (FET) Cycles: Randomized Clinical Trial
Status: Not yet recruiting Condition: In Vitro Fertilization; Embryo Transfer; Drug Effects

Dydrogesterone Versus Intravaginal Progesterone in the Luteal Phase Support
Status: Completed Condition: Luteal Phase Defect

Progesterone for the Treatment of Traumatic Brain Injury III
Status: Terminated Condition: Traumatic Brain Injury

Vaginal Progesterone in Twins With Short Cervix
Status: Withdrawn Condition: Premature Birth

Luteal Phase Progesterone in IUI and Gonadotropin Cycles
Status: Recruiting Condition: Infertility

Assessment of the Sensitivity of the Hypothalamic Gonadotropin-releasing Hormone (GnRH) Pulse Generator to Estradiol and Progesterone Inhibition
Status: Recruiting Condition: Hyperandrogenemia; Polycystic Ovary Syndrome (PCOS)

Prolongation of Progesterone Supplementation in Antagonist Cycles and Pregnancy Outcomes
Status: Completed Condition: Infertility

Progesterone Reduces Wakefulness in Sleep EEG and Has no Effect on Cognition in Healthy Postmenopausal Women
Status: Completed Condition: Healthy; Postmenopausal

Progesterone Rise in Agonist Versus Antagonist in Vitro Fertilization (IVF) Cycles
Status: Active, not recruiting Condition: Pregnancy Outcome After In Vitro Fertilization (IVF)

Comparison of DR-2011 to a Progesterone Vaginal Gel for Luteal Phase Replacement
Status: Completed Condition: Infertility

17 Alfa Hydroxyprogesterone Caproate Versus Natural Progesterone for the Prevention of Preterm Labor
Status: Active, not recruiting Condition: Pregnancy

Vasomotor Symptoms (VMS) Progesterone Study: Vasomotor Symptoms and Endothelial Function - Trial of Oral Micronized Progesterone
Status: Active, not recruiting Condition: Menopause

Progesterone on the Day of Ovulation Induction is Associated With Pregnancy Outcome
Status: Completed Condition: Female Infertility

Progesterone for Maintenance Tocolysis: A Randomized Placebo Controlled Trial
Status: Active, not recruiting Condition: Pregnancy Complications

Vaginal Progesterone to Reduce the Risk of Another Preterm Birth
Status: Completed Condition: Pregnancy

Progesterone for the Prevention of Miscarriage and Preterm Birth in Women With First Trimester Bleeding: PREEMPT Trial
Status: Recruiting Condition: Miscarriage; Preterm Birth

Progesterone vs Clobetasol Propionate in Vulvar Lichen Sclerosus
Status: Terminated Condition: Vulvar Lichen Sclerosus

Vaginal Progesterone Versus Placebo in Multiple Pregnancy
Status: Completed Condition: Preterm Birth

Effects of Progesterone on IV Nicotine-Induced Changes in Hormones and Subjective Ratings of Stimulant Drug Effect
Status: Suspended Condition: Nicotine Dependence

Optimal Length of Progesterone Supplementation Before the Transfer of Cryopreserved(Frozen)-Thawed Embryos in an Artificial Cycle With Exogenous Estrogen and Progesterone.
Status: Recruiting Condition: Cryopreservation; Embryo Implantation; Progesteron

Preterm Delivery Prevention in Twins With Progesterone
Status: Active, not recruiting Condition: Pregnancies

Progesterone Suppression of Nocturnal LH Increases in Pubertal Girls
Status: Active, not recruiting Condition: Female Puberty

Progesterone & Postpartum Relapse to Smoking
Status: Recruiting Condition: Tobacco Use Cessation; Tobacco Use Disorder

Comparing Double Dose of Vaginal Progesterone to no Treatment for Prevention of Preterm Birth in Twins and Short Cervix
Status: Not yet recruiting Condition: Premature Birth

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

Acute Effects of Progesterone on LH Pulses During the Follicular Phase
Status: Active, not recruiting Condition: Female Reproductive Physiology

Utrogestan Versus Nifedipine as Tocolysis for Preterm Labor: a Randomised Controlled Trial
Status: Not yet recruiting Condition: Preterm Labor

Lactoferrin or Progesterone for Prevention of Preterm Delivery
Status: Recruiting Condition: Preterm Delivery

Progesterone Treatment of Blunt Traumatic Brain Injury
Status: Completed Condition: Traumatic Brain Injury

Sex Differences, Hormones & Smoking Cessation
Status: Recruiting Condition: Tobacco Cessation

A Pharmacokinetic Study to Evaluate the Bioequivalence of 2 Progesterone Vaginal Rings in Postmenopausal Women
Status: Completed Condition: Pharmacokinetics

Subcutaneous Progesterone Versus Vaginal Progesterone Tablets for Luteal Phase Support in In Vitro Fertilization (IVF)
Status: Completed Condition: In Vitro Fertilization

Menopur® Versus Follistim® in Polycystic Ovarian Syndrome (PCOS)
Status: Completed Condition: Polycystic Ovarian Syndrome; Infertility

A Pharmacokinetic Evaluation of Bioidentical Compounded Estrogen Cream and Natural Progesterone
Status: Completed Condition: Menopause

Progesterone Vaginal Pessary for Prevention of Preterm Twin Birth
Status: Completed Condition: Preterm Birth

Progesterone for the Treatment of Cocaine Dependence - 1
Status: Completed Condition: Cocaine Abuse; Cocaine-Related Disorders

Relationship Between Mid-luteal Serum Progesterone Levels to Pregnancy Rates in Assisted Reproductive Techniques (ART)
Status: Not yet recruiting Condition: Infertility

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

The Use of Progesterone to Reduce Preterm Birth
Status: Completed Condition: Preterm Birth

Phase 3 Trial to Evaluate the Efficacy and Safety of COL-1620 Vaginal Progesterone Gel
Status: Completed Condition: Luteal Hormone Supplementation in In-vitro Fertilization; Embryo Transfer

The Luteal Phase After GnRHa Trigger - a Proof of Concept Study
Status: Completed Condition: Progesterone Levels; Infertility

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

Suppression of Daytime and Nighttime Luteinizing Hormone Frequency by Progesterone
Status: Recruiting Condition: Polycystic Ovary Syndrome; Hyperandrogenism

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actavis Labs Ut Inc
CRINONE
progesterone
GEL;VAGINAL020701-001Jul 31, 1997RXNo<disabled><disabled>
Banner Life Sciences
PROGESTERONE
progesterone
CAPSULE;ORAL200900-002Aug 16, 2013RXNo<disabled><disabled>
Ferring
ENDOMETRIN
progesterone
INSERT;VAGINAL022057-001Jun 21, 2007RXYes7,300,664<disabled><disabled>
Sofgen Pharms
PROGESTERONE
progesterone
CAPSULE;ORAL200456-001Sep 28, 2012RXNo<disabled><disabled>
Banner Life Sciences
PROGESTERONE
progesterone
CAPSULE;ORAL200900-001Aug 16, 2013RXNo<disabled><disabled>
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International Patent Family for Ingredient: progesterone

Country Document Number Publication Date
Japan2011026335Feb 10, 2011
Japan4667601Apr 13, 2011
Japan2002529494Sep 10, 2002
World Intellectual Property Organization (WIPO)0028970May 25, 2000
Australia1176200Jun 05, 2000
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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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