levothyroxine sodium · Ibsa · NDA 206977
Tirosint-Sol
Earliest generic entry, as listed · earliest of 15 marketed strengths
26 Sep 2044
Blocked by patent: US 12564565.
Listed patents · 4 unexpired
5 Orange Book listing rows for 4 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 12564565 | drug product · sets the listed date | 26 Sep 2044 |
| US 11241382 | use U-3757, U-3758 | 17 Sep 2039 |
| US 11241382 listing row | use U-3757 | 17 Sep 2039 |
| US 11241382 listing row | use U-3758 | 17 Sep 2039 |
| US 10537538 | drug product | 28 Feb 2037 |
| US 11096913 | drug product | 28 Feb 2037 |
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 · 15
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 206977 · 001 · RLD | solution, oral | 13MCG/ML | 26 Sep 2044 |
| 206977 · 002 · RLD | solution, oral | 25MCG/ML | 26 Sep 2044 |
| 206977 · 003 · RLD | solution, oral | 50MCG/ML | 26 Sep 2044 |
| 206977 · 004 · RLD | solution, oral | 75MCG/ML | 26 Sep 2044 |
| 206977 · 005 · RLD | solution, oral | 88MCG/ML | 26 Sep 2044 |
| 206977 · 006 · RLD | solution, oral | 100MCG/ML | 26 Sep 2044 |
| 206977 · 007 · RLD | solution, oral | 112MCG/ML | 26 Sep 2044 |
| 206977 · 008 · RLD | solution, oral | 125MCG/ML | 26 Sep 2044 |
| 206977 · 009 · RLD | solution, oral | 137MCG/ML | 26 Sep 2044 |
| 206977 · 010 · RLD | solution, oral | 150MCG/ML | 26 Sep 2044 |
| 206977 · 011 · RLD | solution, oral | 175MCG/ML | 26 Sep 2044 |
| 206977 · 012 · RLD | solution, oral | 200MCG/ML | 26 Sep 2044 |
| 206977 · 013 · RLD | solution, oral | 37.5MCG/ML | 26 Sep 2044 |
| 206977 · 014 · RLD | solution, oral | 44MCG/ML | 26 Sep 2044 |
| 206977 · 015 · RLD | solution, oral | 62.5MCG/ML | 26 Sep 2044 |