Last reviewed · How we verify
Mirena®
Mirena® is a marketed product by FHI 360, positioned in the contraceptive market. A key strength is its patent protection, which extends to 2028 for the key composition patent. The primary risk is the eventual patent expiry in 2028, which could lead to increased competition from generics.
At a glance
| Generic name | Mirena® |
|---|---|
| Also known as | LNG-IUS, IUD, Progestin-releasing intra-uterine device (pIUD), IUD |
| Sponsor | FHI 360 |
| Modality | Small molecule |
| Phase | FDA-approved |
Approved indications
Common side effects
Key clinical trials
- Postplacental Copper Intrauterine Device Versus Postpartum Progesterone-only Pills on Uterine Niche Formation (NA)
- Comparison of Sequential CFA vs CFA +rFSH for Elective Fertility Preservation. (PHASE3)
- Oral Contraceptive Pills Versus Levonorgestrel-Releasing Intrauterine System for Niche-Related Abnormal Uterine Bleeding (NA)
- Subdermal Implant-bioabsorbable Gestrinone Pellet for Endometriosis Pelvic Pain Treatment (PHASE2)
- Functional Study of the Hypothalamus in Magnetic Resonance Imaging (MRI) in Polycystic Ovary Syndrome (PCOS) (NA)
- Improving the Treatment for Women With Early Stage Cancer of the Uterus (PHASE2)
- Comparison of Two PPOS Models for Pituitary Suppression (NA)
- Mirena® IUD's Effect on Fallopian Tube Fimbriae and Ovarian Cortical Inclusion Cyst Cell Proliferation (NA)
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:
- Mirena® CI brief — competitive landscape report
- Mirena® updates RSS · CI watch RSS
- FHI 360 portfolio CI