FDA Orange Book
Is there a generic for Tirosint?
Tirosint 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 (levothyroxine). The Orange Book shows its last listed patent expires September 26, 2044.
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Tirosint products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 0.013MG | Marketed (Rx) | None | 0 | None |
| capsule, oral | 0.025MG | Marketed (Rx) | None | 0 | None |
| capsule, oral | 0.0375MG | Marketed (Rx) | None | 0 | None |
| capsule, oral | 0.044MG | Marketed (Rx) | None | 0 | None |
| capsule, oral | 0.05MG | Marketed (Rx) | None | 0 | None |
| capsule, oral | 0.0625MG | Marketed (Rx) | None | 0 | None |
| capsule, oral | 0.075MG | Marketed (Rx) | None | 0 | None |
| capsule, oral | 0.088MG | Marketed (Rx) | None | 0 | None |
| capsule, oral | 0.112MG | Marketed (Rx) | None | 0 | None |
| capsule, oral | 0.125MG | Marketed (Rx) | None | 0 | None |
| capsule, oral | 0.137MG | Marketed (Rx) | None | 0 | None |
| capsule, oral | 0.15MG | Marketed (Rx) | None | 0 | None |
| capsule, oral | 0.175MG | Marketed (Rx) | None | 0 | None |
| capsule, oral | 0.1MG | Marketed (Rx) | None | 0 | None |
| capsule, oral | 0.2MG | Marketed (Rx) | None | 0 | None |
NDA 021924, 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 patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12564565 | September 26, 2044 | Drug product | None | 021924 |
Tirosint NDC codes
Questions
Is there a generic for Tirosint?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Tirosint (levothyroxine). The Orange Book shows its last listed patent expires September 26, 2044.
What is the generic name for Tirosint?
The active ingredient in Tirosint is levothyroxine, per the FDA Orange Book.
When does the Tirosint patent expire?
The last patent listed for Tirosint 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.
More on Tirosint and Levothyroxine
- What is Tirosint used for?FDA label uses
- Is Tirosint a controlled substance?Federal schedule
- What is Levothyroxine used for?FDA label uses
- Is Levothyroxine a controlled substance?Federal schedule
- Generic for ThyquidityFDA Orange Book
- Generic for Tirosint-solFDA Orange Book
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- Generic for Thyro-tabsFDA Orange Book
- Generic for UnithroidFDA Orange Book
- L-Thyroxines listFDA drug class
- Tirosint Medicare Part D coverageBy plan and state
- NDC 71858-0005Tirosint NDC record
- NDC 71858-0010Tirosint NDC record