FDA Orange Book
Is there a generic for Tirosint-sol?
Tirosint-sol 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
No. The Orange Book lists no active FDA-approved generic (ANDA) for Tirosint-sol (levothyroxine). The Orange Book shows its last listed patent expires September 26, 2044.
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Tirosint-sol products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, oral | 100MCG/ML | Marketed (Rx) | None | 0 | None |
| solution, oral | 112MCG/ML | Marketed (Rx) | None | 0 | None |
| solution, oral | 125MCG/ML | Marketed (Rx) | None | 0 | None |
| solution, oral | 137MCG/ML | Marketed (Rx) | None | 0 | None |
| solution, oral | 13MCG/ML | Marketed (Rx) | None | 0 | None |
| solution, oral | 150MCG/ML | Marketed (Rx) | None | 0 | None |
| solution, oral | 175MCG/ML | Marketed (Rx) | None | 0 | None |
| solution, oral | 200MCG/ML | Marketed (Rx) | None | 0 | None |
| solution, oral | 25MCG/ML | Marketed (Rx) | None | 0 | None |
| solution, oral | 37.5MCG/ML | Marketed (Rx) | None | 0 | None |
| solution, oral | 44MCG/ML | Marketed (Rx) | None | 0 | None |
| solution, oral | 50MCG/ML | Marketed (Rx) | None | 0 | None |
| solution, oral | 62.5MCG/ML | Marketed (Rx) | None | 0 | None |
| solution, oral | 75MCG/ML | Marketed (Rx) | None | 0 | None |
| solution, oral | 88MCG/ML | Marketed (Rx) | None | 0 | None |
NDA 206977, held by IBSA INSTITUT BIOCHIMIQUE SA. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Tirosint-sol patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11096913 | February 28, 2037 | Drug product | None | 206977 |
| 10537538 | February 28, 2037 | Drug product | None | 206977 |
| 11241382 | September 17, 2039 | Method of use | U-3757 | 206977 |
| 11241382 | September 17, 2039 | Method of use | U-3758 | 206977 |
| 12564565 | September 26, 2044 | Drug product | None | 206977 |
Tirosint-sol NDC codes
Questions
Is there a generic for Tirosint-sol?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Tirosint-sol (levothyroxine). The Orange Book shows its last listed patent expires September 26, 2044.
What is the generic name for Tirosint-sol?
The active ingredient in Tirosint-sol is levothyroxine, per the FDA Orange Book.
When does the Tirosint-sol patent expire?
The last patent listed for Tirosint-sol in the Orange Book expires September 26, 2044. 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.