levonorgestrel · Bayer Hlthcare · NDA 021225
Mirena
Earliest generic entry, as listed
16 Sep 2029
Blocked by patent: US 10561524. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 2 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10561524 | use U-2948 | 16 Sep 2029 |
| US 11850182 | product, use U-3819 | 14 Sep 2029 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 021225 · 001 · RLD | system, intrauterine | 52MG | 16 Sep 2029 |