fluticasone propionate; salmeterol xinafoate · Teva Pharm · NDA 208799
Airduo Digihaler
Earliest generic entry, as listed · earliest of 3 marketed strengths
6 Jan 2041
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 11173259.
Listed patents · 14 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11173259 | — | 6 Jan 2041 |
| US 11173259 | product | 6 Jul 2040 |
| US 11344685 | — | 26 Mar 2040 |
| US 11969544 | — | 20 Feb 2040 |
| US 11344685 | product | 26 Sep 2039 |
| US 11969544 | product | 20 Aug 2039 |
| US 10918816 | — | 14 Jun 2036 |
| US 10918816 | product | 14 Dec 2035 |
| US 9066957 | — | 6 Apr 2035 |
| US 9415008 | — | 6 Apr 2035 |
| US 9066957 | product, use U-645 | 6 Oct 2034 |
| US 9415008 | product, use U-645 | 6 Oct 2034 |
| US 10195375 | — | 14 Aug 2031 |
| US 10195375 | product | 14 Feb 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
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 208799 · 004 · RLD · discontinued | powder, inhalation | 0.055MG/INH;EQ 0.014MG BASE/INH | 6 Jan 2041 |
| 208799 · 005 · RLD · discontinued | powder, inhalation | 0.113MG/INH;EQ 0.014MG BASE/INH | 6 Jan 2041 |
| 208799 · 006 · RLD · discontinued | powder, inhalation | 0.232MG/INH;EQ 0.014MG BASE/INH | 6 Jan 2041 |