testosterone undecanoate · Marius · NDA 213953
Kyzatrex
Earliest generic entry, as listed · earliest of 3 marketed strengths
29 Mar 2041
1 of 3 marketed strengths has no unexpired patent or exclusivity listed.
Blocked by patent: US 12403146.
Listed patents · 6 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12403146 | drug product, use U-2506 · sets the listed date | 29 Mar 2041 |
| US 11617758 | drug product, use U-2506 | 15 Mar 2033 |
| US 12357643 | drug product, use U-2506 | 15 Mar 2033 |
| US 10576089 | drug product, use U-2506 | 31 Dec 2030 |
| US 10576090 | drug product | 31 Dec 2030 |
| US 11590146 | drug product | 31 Dec 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 · 4
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 213953 · 001 · RLD · discontinued | capsule, oral | 100MG | 29 Mar 2041 |
| 213953 · 002 · RLD | capsule, oral | 150MG | 29 Mar 2041 |
| 213953 · 003 · RLD | capsule, oral | 200MG | 29 Mar 2041 |
| 213953 · 004 · RLD | capsule, oral | 50MG | open |