memantine hydrochloride · Abbvie · NDA 022525
Namenda Xr
Earliest generic entry, as listed · earliest of 4 marketed strengths
24 Sep 2029
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 8039009.
Listed patents · 2 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8039009 | — | 24 Sep 2029 |
| US 8039009 | use U-539 | 24 Mar 2029 |
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 |
|---|---|---|---|
| 022525 · 001 · RLD · discontinued | capsule, extended release, oral | 7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 24 Sep 2029 |
| 022525 · 002 · RLD · discontinued | capsule, extended release, oral | 14MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 24 Sep 2029 |
| 022525 · 003 · RLD · discontinued | capsule, extended release, oral | 21MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 24 Sep 2029 |
| 022525 · 004 · RLD · discontinued | capsule, extended release, oral | 28MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 24 Sep 2029 |