FDA Orange Book
Generic for Alinia
Alinia contains nitazoxanide. 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 Alinia is nitazoxanide. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 Alinia products the Orange Book lists.
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Alinia products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| for suspension, oral | 100MG/5ML | Discontinued | None | 0 | None |
| tablet, oral | 500MG | Discontinued | None | 3 | AB |
NDA 021498, 021497, held by ROMARK LABORATORIES. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic nitazoxanide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| RISING PHARMA HOLDINGS INC | 213820 | AB (A-rated, therapeutically equivalent) | November 27, 2020 | 500MG |
| ANI PHARMACEUTICALS INC | 214844 | AB (A-rated, therapeutically equivalent) | February 3, 2025 | 500MG |
| ANNORA PHARMA PRIVATE LTD | 218701 | AB (A-rated, therapeutically equivalent) | April 15, 2025 | 500MG |
Questions
Is there a generic for Alinia?
Yes. The generic name for Alinia is nitazoxanide. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 Alinia products the Orange Book lists.
What is the generic name for Alinia?
The active ingredient in Alinia is nitazoxanide, 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.