dienogest; estradiol valerate · Bayer Hlthcare · NDA 022252
Natazia
Earliest generic entry, as listed
30 Jan 2028
Blocked by patent: US 8153616. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8153616 | use U-1240 | 30 Jan 2028 |
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 |
|---|---|---|---|
| 022252 · 001 · RLD | tablet, oral | N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A | 30 Jan 2028 |
Expired or delisted (1)
- US 8071577 · product, use U-1 · 13 May 2026