fluticasone propionate · Teva Pharm · NDA 208798
Armonair Digihaler
Earliest generic entry, as listed · earliest of 4 marketed strengths
6 Jan 2041
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 11173259 (pediatric extension).
Listed patents · 5 unexpired
10 Orange Book listing rows for 5 patents, including 5 pediatric extensions. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 11173259 | drug product | 6 Jan 2041 |
| US 11173259 listing row | drug product | 6 Jul 2040 |
| US 11173259 listing row | pediatric extension · sets the listed date | 6 Jan 2041 |
| US 11344685 | drug product | 26 Mar 2040 |
| US 11344685 listing row | drug product | 26 Sep 2039 |
| US 11344685 listing row | pediatric extension | 26 Mar 2040 |
| US 11969544 | drug product | 20 Feb 2040 |
| US 11969544 listing row | drug product | 20 Aug 2039 |
| US 11969544 listing row | pediatric extension | 20 Feb 2040 |
| US 10918816 | drug product | 14 Jun 2036 |
| US 10918816 listing row | drug product | 14 Dec 2035 |
| US 10918816 listing row | pediatric extension | 14 Jun 2036 |
| 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
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 4
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 208798 · 004 · RLD · discontinued | powder, inhalation | 0.055MG/INH | 6 Jan 2041 |
| 208798 · 005 · RLD · discontinued | powder, inhalation | 0.113MG/INH | 6 Jan 2041 |
| 208798 · 006 · RLD · discontinued | powder, inhalation | 0.232MG/INH | 6 Jan 2041 |
| 208798 · 008 · RLD · discontinued | powder, inhalation | 0.03MG/INH | 6 Jan 2041 |