FDA Orange Book
Generic for Levolet
Levolet contains levothyroxine. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Levolet is levothyroxine. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1,AB2,AB3, AB1,AB2,AB3,AB4, AB2, AB4.
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Levolet products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Marketed (Rx) | AB1,AB2,AB3,AB4 | 7 | AB1,AB2,AB3,AB4, AB1,AB2,AB3, AB4, AB2 |
| tablet, oral | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Marketed (Rx) | AB1,AB2,AB3,AB4 | 7 | AB1,AB2,AB3,AB4, AB1,AB2,AB3, AB4, AB2 |
| tablet, oral | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Marketed (Rx) | AB1,AB2,AB3,AB4 | 7 | AB1,AB2,AB3,AB4, AB1,AB2,AB3, AB4, AB2 |
| tablet, oral | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Marketed (Rx) | AB1,AB2,AB3,AB4 | 7 | AB1,AB2,AB3,AB4, AB1,AB2,AB3, AB4, AB2 |
| tablet, oral | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Marketed (Rx) | AB1,AB2,AB3,AB4 | 7 | AB1,AB2,AB3,AB4, AB1,AB2,AB3, AB4, AB2 |
| tablet, oral | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Marketed (Rx) | AB1,AB2,AB3,AB4 | 7 | AB1,AB2,AB3,AB4, AB1,AB2,AB3, AB4, AB2 |
| tablet, oral | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Marketed (Rx) | AB1,AB2,AB3,AB4 | 7 | AB1,AB2,AB3,AB4, AB1,AB2,AB3, AB4, AB2 |
| tablet, oral | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Marketed (Rx) | AB1,AB2,AB3,AB4 | 7 | AB1,AB2,AB3,AB4, AB1,AB2,AB3, AB4, AB2 |
| tablet, oral | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Marketed (Rx) | AB1,AB2,AB3,AB4 | 7 | AB1,AB2,AB3,AB4, AB1,AB2,AB3, AB4, AB2 |
| tablet, oral | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Marketed (Rx) | AB1,AB2,AB3,AB4 | 7 | AB1,AB2,AB3,AB4, AB1,AB2,AB3, AB4, AB2 |
| tablet, oral | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Marketed (Rx) | AB1,AB2,AB3,AB4 | 7 | AB1,AB2,AB3,AB4, AB1,AB2,AB3, AB4, AB2 |
| tablet, oral | 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Marketed (Rx) | AB1,AB2,AB3,AB4 | 7 | AB1,AB2,AB3,AB4, AB1,AB2,AB3, AB4, AB2 |
NDA 021137, held by GENUS LIFE SCIENCES INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic levothyroxine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| MYLAN PHARMACEUTICALS INC | 076187 | AB1,AB2,AB3,AB4 (A-rated, therapeutically equivalent) | June 5, 2002 | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium |
| LUPIN INC | 209713 | AB1,AB2,AB3 (A-rated, therapeutically equivalent) | January 18, 2019 | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium |
| ACCORD HEALTHCARE INC | 212399 | AB1,AB2,AB3,AB4 (A-rated, therapeutically equivalent) | October 19, 2020 | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium |
| WATSON LABORATORIES INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC | 207588 | AB1,AB2,AB3,AB4 (A-rated, therapeutically equivalent) | May 10, 2022 | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium |
| MACLEODS PHARMACEUTICALS LTD | 211417 | AB1,AB2,AB3,AB4 (A-rated, therapeutically equivalent) | December 21, 2022 | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium |
| ASCENT PHARMACEUTICALS INC | 215259 | AB4 (A-rated, therapeutically equivalent) | January 18, 2023 | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium |
| ALEMBIC PHARMACEUTICALS LTD | 216370 | AB2 (A-rated, therapeutically equivalent) | May 20, 2026 | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium |
Levolet patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10406108 | March 23, 2038 | Drug product | None | 021137 |
| 10231931 | March 23, 2038 | Drug product | None | 021137 |
Questions
Is there a generic for Levolet?
Yes. The generic name for Levolet is levothyroxine. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1,AB2,AB3, AB1,AB2,AB3,AB4, AB2, AB4.
What is the generic name for Levolet?
The active ingredient in Levolet is levothyroxine, per the FDA Orange Book.
When does the Levolet patent expire?
The last patent listed for Levolet in the Orange Book expires March 23, 2038. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.