drospirenone; ethinyl estradiol; levomefolate calcium · Bayer Hlthcare · NDA 022532
Beyaz
Earliest generic entry, as listed
17 Jul 2030
Blocked by patent: US 11617751.
Listed patents · 2 unexpired
5 Orange Book listing rows for 2 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 11617751 | drug product, use U-1, U-3572, U-3573, U-3574 | 17 Jul 2030 |
| US 11617751 listing row | drug product, use U-1 · sets the listed date | 17 Jul 2030 |
| US 11617751 listing row | drug product, use U-3572 · sets the listed date | 17 Jul 2030 |
| US 11617751 listing row | drug product, use U-3573 · sets the listed date | 17 Jul 2030 |
| US 11617751 listing row | drug product, use U-3574 · sets the listed date | 17 Jul 2030 |
| US 8617597 | drug product | 8 Feb 2030 |
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 |
|---|---|---|---|
| 022532 · 001 · RLD | tablet, oral | 3MG,N/A;0.02MG,N/A;0.451MG,0.451MG | 17 Jul 2030 |