tiotropium bromide · Boehringer Ingelheim · NDA 021936
Spiriva Respimat
Earliest generic entry, as listed · earliest of 2 marketed strengths
16 Apr 2031
1 of 2 marketed strengths has no unexpired patent or exclusivity listed.
Blocked by patent: US 8733341.
Listed patents · 4 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8733341 | — | 16 Apr 2031 |
| US 7837235 | — | 13 Sep 2028 |
| US 9027967 | — | 30 Sep 2027 |
| US 7396341 | — | 10 Apr 2027 |
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 · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 021936 · 001 · RLD | spray, metered, inhalation | EQ 0.0025MG BASE/INH | 16 Apr 2031 |
| 021936 · 002 · RLD | spray, metered, inhalation | EQ 0.00125MG BASE/INH | open |
Expired or delisted (4)
- US 8733341 · product · 16 Oct 2030 · delisted
- US 7837235 · product · 13 Mar 2028 · delisted
- US 9027967 · product · 31 Mar 2027 · delisted
- US 7396341 · product · 10 Oct 2026 · delisted