elinzanetant · Bayer Hlthcare · NDA 219469
Lynkuet
Earliest generic entry, as listed
14 May 2045
Blocked by patent: US 12533358. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 6 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12533358 | use U-4402 · sets the listed date | 14 May 2045 |
| US 10774091 | drug product | 13 Mar 2039 |
| US 11787820 | use U-3622 | 13 Mar 2039 |
| US 12264164 | use U-3622 | 13 Mar 2039 |
| US 10195205 | use U-3622 | 18 May 2036 |
| US 7683056 | drug substance, drug product | 15 Sep 2027 |
Exclusivities · 1 unexpired
| NCE | new chemical entity (5 years) | 24 Oct 2030 |
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 |
|---|---|---|---|
| 219469 · 001 · RLD | capsule, oral | 60MG | 14 May 2045 |