FDA Orange Book
Is there a generic for Emcitate?
Emcitate contains tiratricol. 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 Emcitate (tiratricol).
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Emcitate products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, for suspension, oral | 350MCG | Marketed (Rx) | None | 0 | None |
NDA 220963, held by RARE THYROID THERAPEUTICS INTERNATIONAL AB. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Questions
Is there a generic for Emcitate?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Emcitate (tiratricol).
What is the generic name for Emcitate?
The active ingredient in Emcitate is tiratricol, per the FDA Orange Book.
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.