omeprazole · Dexcel Pharma · NDA 022032, 209400
Omeprazole
Earliest generic entry, as listed · earliest of 2 marketed strengths
31 Jan 2030
Other strengths are listed to 8 Dec 2036.
Blocked by patent: US 12599565.
Listed patents · 3 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10076494 | drug product | 8 Dec 2036 |
| US 10835488 | drug product | 8 Dec 2036 |
| US 12599565 | drug product · sets the listed date | 31 Jan 2030 |
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 |
|---|---|---|---|
| 022032 · 001 · RLD | tablet, delayed release, oral | 20MG | 31 Jan 2030 |
| 209400 · 001 · RLD | tablet, orally disintegrating, delayed release, oral | 20MG | 8 Dec 2036 |