esomeprazole magnesium · Astrazeneca · NDA 021153, 021957, 022101
Nexium
Earliest generic entry, as listed · earliest of 7 marketed strengths
Open now
No unexpired patents or exclusivities are listed for this product.
Listed patents · 0 unexpired
No unexpired patents listed.
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 · 022101-00125 Sep 2026
- 25 Oct 2026Generic approved · 021957-00125 Sep 2026
Products covered · 7
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 021153 · 001 · RLD | capsule, delayed rel pellets, oral | EQ 20MG BASE | open |
| 021153 · 002 · RLD | capsule, delayed rel pellets, oral | EQ 40MG BASE | open |
| 021957 · 001 · RLD | for suspension, delayed release, oral | EQ 20MG BASE/PACKET | open |
| 021957 · 002 · RLD | for suspension, delayed release, oral | EQ 40MG BASE/PACKET | open |
| 021957 · 003 · RLD | for suspension, delayed release, oral | EQ 2.5MG BASE/PACKET | open |
| 021957 · 004 · RLD | for suspension, delayed release, oral | EQ 5MG BASE/PACKET | open |
| 022101 · 001 · RLD | for suspension, delayed release, oral | EQ 10MG BASE/PACKET | open |