FDA Orange Book
Generic for Patanase
Patanase contains olopatadine. 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 Patanase is olopatadine. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Patanase products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| spray, metered, nasal | 0.665MG/SPRAY | Discontinued | None | 3 | AB |
NDA 021861, held by NOVARTIS PHARMACEUTICALS CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic olopatadine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| APOTEX INC | 091572 | AB (A-rated, therapeutically equivalent) | October 8, 2014 | 0.665MG/SPRAY |
| PADAGIS ISRAEL PHARMACEUTICALS LTD | 202853 | AB (A-rated, therapeutically equivalent) | January 31, 2017 | 0.665MG/SPRAY |
| AMNEAL PHARMACEUTICALS LLC | 210901 | AB (A-rated, therapeutically equivalent) | January 28, 2020 | 0.665MG/SPRAY |
Questions
Is there a generic for Patanase?
Yes. The generic name for Patanase is olopatadine. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Patanase?
The active ingredient in Patanase is olopatadine, 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.