testosterone undecanoate · Verity · NDA 208088
Tlando
Earliest generic entry, as listed
28 Apr 2041
Blocked by patent: US 11464735, US 12691057.
Listed patents · 15 unexpired
16 Orange Book listing rows for 15 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 11464735 | drug product, use U-1500 · sets the listed date | 28 Apr 2041 |
| US 12691057 | drug product, use U-4194 · sets the listed date | 28 Apr 2041 |
| US 12011503 | drug product, use U-3964, U-3965 | 16 Oct 2040 |
| US 12011503 listing row | drug product, use U-3964 | 16 Oct 2040 |
| US 12011503 listing row | drug product, use U-3965 | 16 Oct 2040 |
| US 12310978 | use U-4194 | 21 Feb 2039 |
| US 11559530 | use U-1500 | 28 Nov 2037 |
| US 10226473 | use U-1500 | 30 Nov 2030 |
| US 10716794 | use U-1500 | 30 Nov 2030 |
| US 11311555 | use U-1500 | 30 Nov 2030 |
| US 11364249 | use U-1500 | 30 Nov 2030 |
| US 11433083 | use U-1500 | 30 Nov 2030 |
| US 9943527 | use U-1500 | 30 Nov 2030 |
| US 9949985 | use U-1500 | 30 Nov 2030 |
| US 11304960 | drug product, use U-1500 | 8 Jan 2029 |
| US 8778922 | drug product, use U-1500 | 8 Jan 2029 |
| US 8865695 | use U-1500 | 8 Jan 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 |
|---|---|---|---|
| 208088 · 001 · RLD | capsule, oral | 112.5MG | 28 Apr 2041 |