Last reviewed · How we verify
Ortho-Novum 10/11-21 (Ethinylestradiol)
At a glance
| Generic name | Ethinylestradiol |
|---|---|
| Sponsor | Merck & Co. |
| Drug class | Estrogen |
| Target | Estrogen receptor |
| Modality | Small molecule |
| Therapeutic area | Bone |
| Phase | FDA-approved |
| First approval | 1943 |
Approved indications
- Acne vulgaris
- Atrophic vaginitis
- Atrophic vulva
- Contraception
- Controlled ovarian stimulation
- Dysmenorrhea
- Menopausal flushing
- Postmenopausal osteoporosis
- Premenstrual dysphoric disorder
Common side effects
Drug interactions
- atazanavir
- darunavir
- felbamate
- fosamprenavir
- fosphenytoin
- griseofulvin
- letrozole
- lopinavir
- methylphenobarbital
- modafinil
- nafcillin
- nelfinavir
Key clinical trials
- Anxiety and Depression in Adolescent PCOS (NA)
- An Ethno-bridging Study of Pergoveris in Healthy Premenopausal Participants of Japanese or Caucasian Origin (PHASE1)
- A Drug-drug Interaction Study of Vorasidenib and a Combined Oral Contraceptive in Healthy Female Participants (PHASE1)
- A Research Study Looking Into the Effect of NNC0519-0130 on Blood Levels of a Birth Control Pill and Emptying of the Stomach in Women After Menopause (PHASE1)
- The Influence of Combined Oral Contraception on the DEvelopment and progRession of Chronic venoUs diSeases (NA)
- A Study to Investigate the Effect of AZD6234, AZD9550, and a Combination of AZD9550 and AZD6234 on Pharmacokinetics of Combined Oral Contraceptive Ethinyl Estradiol/Levonorgestrel in Healthy Female Participants Living With Overweight or Obesity (PHASE1)
- Effects of VX-407 on the Pharmacokinetics of Oral Contraceptives in Healthy Participants (PHASE1)
- A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuvastatin, and Methotrexate When Administered Together (PHASE1)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Ortho-Novum 10/11-21 CI brief — competitive landscape report
- Ortho-Novum 10/11-21 updates RSS · CI watch RSS
- Merck & Co. portfolio CI