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Oral contraceptives--ethinyl estradiol, levonorgestrel
Oral contraceptives containing ethinyl estradiol and levonorgestrel, marketed by FHI 360, hold a significant position in the contraceptive market. A key strength is the drug's well-established mechanism and broad acceptance, underpinned by a key composition patent expiring in 2028. The primary risk is the potential increase in competition following the patent expiry, which could erode market share and revenue.
At a glance
| Generic name | Oral contraceptives--ethinyl estradiol, levonorgestrel |
|---|---|
| Sponsor | FHI 360 |
| Modality | Small molecule |
| Phase | FDA-approved |
Approved indications
Common side effects
Key clinical trials
- 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)
- 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)
- Oral Contraceptive Pills Versus Levonorgestrel-Releasing Intrauterine System for Niche-Related Abnormal Uterine Bleeding (NA)
- Phase 2b, Open Label, Multisite, Randomized Crossover Study of DPP Versus 2PR (PHASE2)
- A Study of ABBV-295 Subcutaneous Injections to Assess Pharmacokinetics and Adverse Events in Healthy Adult Women Participants With Overweight or Obesity Taking Oral Contraceptives (PHASE1)
- A Study of Elenestinib in Healthy Adult Female Participants (PHASE1)
- A Study to Investigate the Impact of Multiple Doses of Itraconazole on AZD5004 in Healthy Participants and Multiple Doses of AZD5004 on Combined Oral Ethinyl Oestradiol and Levonorgestrel in Healthy Female Participants (PHASE1)
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 |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape: