fluticasone propionate; salmeterol xinafoate · Teva Pharm · NDA 208799
Airduo Respiclick
Blocked by patent: US 11969544 (pediatric extension).
FDA has approved 2 generic applications (ANDAs) for Airduo Respiclick, though its earliest generic-entry date is 20 Feb 2040 as listed. A generic can be approved before that date when it leaves out a patented use (a section viii carve-out), challenges a patent, or settles with the brand company. An approval is not a launch: cliffwatch does not track launches. Approval is not launch
Listed patents · 4 unexpired
8 Orange Book listing rows for 4 patents, including 4 pediatric extensions. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 11969544 | drug product | 20 Feb 2040 |
| US 11969544 listing row | drug product | 20 Aug 2039 |
| US 11969544 listing row | pediatric extension · sets the listed date | 20 Feb 2040 |
| US 9066957 | drug product, use U-645 | 6 Apr 2035 |
| US 9066957 listing row | drug product, use U-645 | 6 Oct 2034 |
| US 9066957 listing row | pediatric extension | 6 Apr 2035 |
| US 9415008 | drug product, use U-645 | 6 Apr 2035 |
| US 9415008 listing row | drug product, use U-645 | 6 Oct 2034 |
| US 9415008 listing row | pediatric extension | 6 Apr 2035 |
| US 10195375 | drug product | 14 Aug 2031 |
| US 10195375 listing row | drug product | 14 Feb 2031 |
| US 10195375 listing row | pediatric extension | 14 Aug 2031 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
- Generic approved · ANDA 213087, Cipla · 208799-001Approved 27 Jul 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 214464, Respirent Pharms · 208799-001Approved 12 Jan 2026Detected 25 Oct 2026Historical import
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 208799 · 001 · RLD | powder, inhalation | 0.055MG/INH;EQ 0.014MG BASE/INH | 20 Feb 2040 |
| 208799 · 002 · RLD | powder, inhalation | 0.113MG/INH;EQ 0.014MG BASE/INH | 20 Feb 2040 |
| 208799 · 003 · RLD | powder, inhalation | 0.232MG/INH;EQ 0.014MG BASE/INH | 20 Feb 2040 |