FDA Orange Book
Generic for Dymista
Dymista contains azelastine and fluticasone propionate. 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 Dymista is azelastine and fluticasone propionate. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Dymista products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| spray, metered, nasal | 0.137MG/SPRAY;0.05MG/SPRAY | Marketed (Rx) | AB | 3 | AB |
NDA 202236, held by MYLAN SPECIALTY LP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic azelastine and fluticasone propionate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| APOTEX INC | 207712 | AB (A-rated, therapeutically equivalent) | April 28, 2017 | 0.137MG/SPRAY;0.05MG/SPRAY |
| PADAGIS ISRAEL PHARMACEUTICALS LTD | 208111 | AB (A-rated, therapeutically equivalent) | February 18, 2021 | 0.137MG/SPRAY;0.05MG/SPRAY |
| TEVA PHARMACEUTICALS USA INC | 208436 | AB (A-rated, therapeutically equivalent) | April 8, 2025 | 0.137MG/SPRAY;0.05MG/SPRAY |
Dymista patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8168620 | February 24, 2026 | Drug product | None | 202236 |
| 8168620*PED | August 24, 2026 | Method of use | None | 202236 |
Dymista NDC codes
Questions
Is there a generic for Dymista?
Yes. The generic name for Dymista is azelastine and fluticasone propionate. 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 Dymista?
The active ingredient in Dymista is azelastine and fluticasone propionate, per the FDA Orange Book.
When does the Dymista patent expire?
The last patent listed for Dymista in the Orange Book expires August 24, 2026. 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.