FDA Orange Book
Is there a generic for AirDuo RespiClick?
AirDuo RespiClick contains fluticasone propionate and salmeterol. 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 AirDuo RespiClick (fluticasone propionate and salmeterol). The Orange Book shows its last listed patent expires February 20, 2040.
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AirDuo RespiClick products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, inhalation | 0.055MG/INH;EQ 0.014MG BASE/INH | Marketed (Rx) | None | 0 | None |
| powder, inhalation | 0.113MG/INH;EQ 0.014MG BASE/INH | Marketed (Rx) | None | 0 | None |
| powder, inhalation | 0.232MG/INH;EQ 0.014MG BASE/INH | Marketed (Rx) | None | 0 | None |
NDA 208799, held by TEVA PHARMACEUTICAL INDUSTRIES LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
AirDuo RespiClick patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10195375 | February 14, 2031 | Drug product | None | 208799 |
| 10195375*PED | August 14, 2031 | Method of use | None | 208799 |
| 9415008 | October 6, 2034 | Drug product | U-645 | 208799 |
| 9066957 | October 6, 2034 | Drug product | U-645 | 208799 |
| 9415008*PED | April 6, 2035 | Method of use | None | 208799 |
| 9066957*PED | April 6, 2035 | Method of use | None | 208799 |
| 11969544 | August 20, 2039 | Drug product | None | 208799 |
| 11969544*PED | February 20, 2040 | Method of use | None | 208799 |
AirDuo RespiClick NDC codes
Questions
Is there a generic for AirDuo RespiClick?
No. The Orange Book lists no active FDA-approved generic (ANDA) for AirDuo RespiClick (fluticasone propionate and salmeterol). The Orange Book shows its last listed patent expires February 20, 2040.
What is the generic name for AirDuo RespiClick?
The active ingredient in AirDuo RespiClick is fluticasone propionate and salmeterol, per the FDA Orange Book.
When does the AirDuo RespiClick patent expire?
The last patent listed for AirDuo RespiClick in the Orange Book expires February 20, 2040. 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.
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