levothyroxine sodium · Fresenius Kabi Usa · NDA 202231, 210632, 214253
Levothyroxine Sodium
Earliest generic entry, as listed · earliest of 6 marketed strengths
3 Oct 2032
Other strengths are listed to 1 Dec 2036.
Blocked by patent: US 9006289.
Listed patents · 8 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10398669 | drug product | 1 Dec 2036 |
| US 11135190 | drug product | 1 Dec 2036 |
| US 12636270 | drug product | 1 Dec 2036 |
| US 9782376 | drug product | 1 Dec 2036 |
| US 11154498 | drug product | 20 Jul 2036 |
| US 9006289 | drug product · sets the listed date | 3 Oct 2032 |
| US 9168238 | drug product | 29 Aug 2032 |
| US 9168239 | drug product | 29 Aug 2032 |
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 · 7
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 202231 · 001 · RLD | powder, intravenous | 100MCG/VIAL | 3 Oct 2032 |
| 202231 · 002 · RLD | powder, intravenous | 200MCG/VIAL | 3 Oct 2032 |
| 202231 · 003 · RLD | powder, intravenous | 500MCG/VIAL | 3 Oct 2032 |
| 210632 · 001 · RLD | solution, intravenous | 100MCG/5ML (20MCG/ML) | 1 Dec 2036 |
| 210632 · 002 · RLD | solution, intravenous | 200MCG/5ML (40MCG/ML) | 1 Dec 2036 |
| 210632 · 003 · RLD | solution, intravenous | 500MCG/5ML (100MCG/ML) | 1 Dec 2036 |
| 214253 · 001 · RLD · discontinued | solution, intravenous | 100MCG/ML | 20 Jul 2036 |