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Details for Generic Name: ethinyl estradiol; norethindrone

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Ethinyl estradiol; norethindrone is the generic ingredient in eigthy-eight branded drugs marketed by Warner Chilcott Llc, Amneal Pharms, Barr, Famy Care Ltd, Warner Chilcott, Actavis Labs Ut Inc, Ortho Mcneil Pharm, LPI, Watson Labs, Ortho Mcneil Janssen, Janssen Pharms, Glenmark Generics, Vintage Pharms Llc, Novast Labs Ltd, Vintage Pharms, Lupin Ltd, Barr Labs Inc, and Parke Davis, and is included in one hundred and three NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are twenty-six drug master file entries for ethinyl estradiol; norethindrone. Nine suppliers are listed for this compound.

Summary for Generic Name: ethinyl estradiol; norethindrone

Tradenames:88
Patents:4
Applicants:18
NDAs:103
Drug Master File Entries: see list26
Suppliers / Packaging: see list22
Formulation / Manufacturing:see details

Clinical Trials for: ethinyl estradiol; norethindrone

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

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

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

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

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

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

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

Effect of Tipranavir and Ritonavir on the Pharmacokinetic Characteristics of Norethindrone-Ethinyl Estradiol in Healthy Female Adult Volunteers
Status: Terminated Condition: Healthy

Study of Safety and Efficacy of an Oral Contraceptive
Status: Completed Condition: Prevention of Pregnancy

Investigation of the Potential Pharmacokinetic Interaction Between Nevirapine (VIRAMUNE) and Ethinyl Estradiol/Norethindrone in HIV-1 Infected Women
Status: Completed Condition: HIV Infections

A Pharmacokinetics (PK) and Safety Study to Determine the Effect of Repeat Dosing of Trametinib on Combined Oral Contraceptive (Norethindrone Plus Ethinyl Estradiol) in Female Subjects With Solid Tumors
Status: Not yet recruiting Condition: Cancer

TMC278-TiDP6-C136: Effect of TMC278 on Ethinylestradiol and Norethindrone in Healthy Women.
Status: Completed Condition: HIV; AIDS; Oral Contraceptive

A Study in Healthy Female Participants Investigating the Effect of TMC435 on the Pharmacokinetics of the Synthetic Hormones of the Oral Contraceptive Ovysmen
Status: Completed Condition: Hepatitis C Virus

Clinical Study Investigating the Conversion of the Contraceptive Compound Norethisterone Within the Body Towards the Contraceptive Compound Ethinylestradiol
Status: Completed Condition: Pharmacokinetics

Study of Safety and Efficacy of an Oral Contraceptive
Status: Completed Condition: Contraception

An Evaluation of the Pharmacokinetics of an Oral Contraceptive (Brevicon) When Co-administered With Albiglutide .
Status: Completed Condition: Healthy Female Volunteers; Diabetes Mellitus, Type 2

Study of Safety and Efficacy of an Oral Contraceptive
Status: Completed Condition: Contraception

A Pharmacokinetics, Pharmacodynamics, and Safety Study of an Oral Contraceptive Containing Norethindrone and Ethinyl Estradiol When Co-administered With GSK1322322 in Healthy Adult Women
Status: Withdrawn Condition: Infections, Bacterial

Gender Disparity and Hormones in Cystic Fibrosis
Status: Recruiting Condition: Cystic Fibrosis (CF)

Study of Bleeding With Extended Administration of an Oral Contraceptive
Status: Completed Condition: Contraception

Efficacy and Safety Study of Low Dose Oral Contraceptive Pill to Treat Dysmenorrhea
Status: Completed Condition: Dysmenorrhea

Efficacy and Safety Study of Low Dose Oral Contraceptive Pill to Treat Primary Dysmenorrhea
Status: Completed Condition: Dysmenorrhea

A Drug-drug Interaction Study Between BMS-663068 and Oral Contraceptives in Healthy Female Volunteers
Status: Not yet recruiting Condition: HIV/AIDS

Efficacy and Safety,Long-term Study of Low-dose Oral Contraceptive Pill to Treat Dysmenorrhea.
Status: Completed Condition: Dysmenorrhea

Post Operative Continuous Active Combination Sex Steroids for the Prevention of Recurrent Endometrioma Formation
Status: Withdrawn Condition: Endometrioma

A Study of Tocilizumab in Combination With an Oral Contraceptive in Patients With Rheumatoid Arthritis
Status: Completed Condition: Rheumatoid Arthritis

Study of the Contraceptive Efficacy and Safety of a NOMAC-E2 Combined Oral Contraceptive (COC)(P06448)
Status: Terminated Condition: Contraception

Evaluation of Physiologic and Standard Sex Steroid Replacement Regimens in Women With Premature Ovarian Failure
Status: Completed Condition: Premature Ovarian Failure

Efficacy and Safety Study of NPC-01 to Treat Dysmenorrhea
Status: Completed Condition: Dysmenorrhea

Randomized Study of Oral Contraceptives or Hormone Replacement Therapy in Women With Systemic Lupus Erythematosus
Status: Completed Condition: Systemic Lupus Erythematosus

Phase II Randomized Study of Leuprolide Vs Oral Contraceptive Therapy Vs Leuprolide and Oral Contraceptive Therapy for Ovarian Hyperandrogenism
Status: Completed Condition: Hyperandrogenism

M0001 Effects on Oral Contraceptive Plasma Levels
Status: Completed Condition: Healthy Volunteers

Evaluate the Effect of VI-0521 on the Pharmacokinetics of Oral Contraceptive in Healthy Female Subjects
Status: Completed Condition: Healthy

Efficacy and Safety, Long-Term Study of NPC-01 to Treat Dysmenorrhea Associated With Endometriosis
Status: Completed Condition: Dysmenorrhea

Treatment of Non-Gestational Acute Uterine Bleeding: A Randomized Trial
Status: Completed Condition: Uterine Hemorrhage; Menorrhagia

A Study to Evaluate the Effects of Different Methods of Birth Control on the Drug Actions of Zidovudine (an Anti-HIV Drug) in HIV-Positive Women and to Compare Zidovudine Metabolism in Men and Women
Status: Completed Condition: HIV Infections

To Compare SH T00658ID Over Ortho Tri-Cyclen Lo (US/Canada)
Status: Completed Condition: Contraception

A Study of Pharmacokinetic Drug Interaction Study of the Hedgehog Pathway Inhibitor GDC-0449 in Combination With Rosiglitazone or Combined Oral Contraceptive in Patients With Locally Advanced or Metastatic Solid Tumors That Are Refractory to Standard Therapy or for Whom No Standard Therapy Exists
Status: Completed Condition: Solid Cancers

Impact of Oral Contraceptives on GABA and Neurosteroids
Status: Terminated Condition: Healthy

Breastfeeding and Oral Contraceptives: a Randomized, Controlled Trial
Status: Completed Condition: Breast Feeding; Contraception

A Study to Evaluate the Acceptability and Preference for Contraceptive Options as Proxy for HIV Prevention Methods
Status: Not yet recruiting Condition: HIV

Drug Interactions Between Lopinavir/Ritonavir and Oral or Patch Contraceptives in HIV Infected Women
Status: Completed Condition: HIV Infections; Pregnancy

Oral Contraceptive (OC) Estrogen Dose and Breast Proliferation
Status: Recruiting Condition: Oral Contraceptive

Oral Contraceptive (OC) Progestin Dose and Breast Proliferation
Status: Completed Condition: Oral Contraceptive

A Study of the Effects of GSK189075 on PK Profiles of an Oral Contraceptive Pill When Given to Healthy Female Volunteers
Status: Completed Condition: Type 2 Diabetes Mellitus; Diabetes Mellitus, Type 2

Study of Loestrin 24(24 Days of "Real" Pills) Fe Versus Loestrin 1/20 (21 "Real" Pills)
Status: Completed Condition: Pelvic Pain; Headaches; Emotional

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
Ortho Mcneil Pharm
ORTHO-NOVUM 7/14-28
ethinyl estradiol; norethindrone
TABLET;ORAL-28019004-002Apr 4, 1984DISCNNo<disabled><disabled>
Famy Care Ltd
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
ethinyl estradiol; norethindrone
TABLET, CHEWABLE;ORAL202086-001Apr 1, 2015RXNo<disabled><disabled>
Famy Care Ltd
NORETHINDRONE AND ETHINYL ESTRADIOL
ethinyl estradiol; norethindrone
TABLET;ORAL-28203006-001Aug 5, 2013RXYes<disabled><disabled>
Novast Labs Ltd
PHILITH
ethinyl estradiol; norethindrone
TABLET;ORAL-28090947-001Dec 22, 2011RXNo<disabled><disabled>
Watson Labs
MICROGESTIN 1/20
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-21075647-002Jul 30, 2003RXNo<disabled><disabled>
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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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