lubiprostone · Sucampo Pharma Llc · NDA 021908
Amitiza
Earliest generic entry, as listed · earliest of 2 marketed strengths
25 Oct 2027
Blocked by patent: US 8026393.
Listed patents · 3 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8026393 | product | 25 Oct 2027 |
| US 8338639 | product | 23 Jan 2027 |
| US 8779187 | product | 23 Jan 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
- 25 Oct 2026Generic approved · 021908-00114 Oct 2026
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 021908 · 001 · RLD | capsule, oral | 24MCG | 25 Oct 2027 |
| 021908 · 002 · RLD | capsule, oral | 8MCG | 25 Oct 2027 |