levothyroxine sodium · Genus Lifesciences · NDA 021137
Levolet
Earliest generic entry, as listed · earliest of 12 marketed strengths
23 Mar 2038
2 of 12 marketed strengths have no unexpired patent or exclusivity listed; no marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 10231931, US 10406108.
Listed patents · 2 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10231931 | drug product · sets the listed date | 23 Mar 2038 |
| US 10406108 | drug product · sets the listed date | 23 Mar 2038 |
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 · 12
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 021137 · 001 | tablet, oral | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | open |
| 021137 · 002 | tablet, oral | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | open |
| 021137 · 003 | tablet, oral | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | 23 Mar 2038 |
| 021137 · 004 | tablet, oral | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | 23 Mar 2038 |
| 021137 · 005 | tablet, oral | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | 23 Mar 2038 |
| 021137 · 006 | tablet, oral | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | 23 Mar 2038 |
| 021137 · 007 | tablet, oral | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | 23 Mar 2038 |
| 021137 · 008 | tablet, oral | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | 23 Mar 2038 |
| 021137 · 009 | tablet, oral | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | 23 Mar 2038 |
| 021137 · 010 | tablet, oral | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | 23 Mar 2038 |
| 021137 · 011 | tablet, oral | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | 23 Mar 2038 |
| 021137 · 012 | tablet, oral | 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | 23 Mar 2038 |