FDA Orange Book
Generic for Optivar
Optivar contains azelastine. 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 Optivar is azelastine. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT.
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Optivar products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution/drops, ophthalmic | 0.05% | Discontinued | None | 5 | AT |
NDA 021127, held by RISING PHARMA HOLDINGS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic azelastine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| APOTEX INC | 078621 | AT (A-rated, therapeutically equivalent) | August 3, 2009 | 0.05% |
| SANDOZ INC | 202305 | AT (A-rated, therapeutically equivalent) | May 31, 2012 | 0.05% |
| ALEMBIC PHARMACEUTICALS LTD | 209620 | AT (A-rated, therapeutically equivalent) | March 20, 2019 | 0.05% |
| SOMERSET THERAPEUTICS LLC | 207411 | AT (A-rated, therapeutically equivalent) | March 29, 2019 | 0.05% |
| GLAND PHARMA LTD | 210092 | AT (A-rated, therapeutically equivalent) | February 25, 2020 | 0.05% |
Questions
Is there a generic for Optivar?
Yes. The generic name for Optivar is azelastine. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT.
What is the generic name for Optivar?
The active ingredient in Optivar is azelastine, 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.