donepezil hydrochloride; memantine hydrochloride · Abbvie · NDA 206439
Namzaric
Blocked by patent: US 8058291. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
FDA has approved 1 generic application (ANDA) for Namzaric, though its earliest generic-entry date is 5 Dec 2029 as listed. A generic can be approved before that date when it leaves out a patented use (a section viii carve-out), challenges a patent, or settles with the brand company. An approval is not a launch: cliffwatch does not track launches. Approval is not launch
Listed patents · 2 unexpired
3 Orange Book listing rows for 2 patents, including 1 pediatric extension. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 8058291 | use U-1641 · sets the listed date | 5 Dec 2029 |
| US 8039009 | use U-1641 | 24 Sep 2029 |
| US 8039009 listing row | use U-1641 | 24 Mar 2029 |
| US 8039009 listing row | pediatric extension | 24 Sep 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
- 25 Oct 2026Generic approved · 206439-00113 Oct 2026
Products covered · 4
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 206439 · 001 · RLD | capsule, extended release, oral | 10MG;14MG | 5 Dec 2029 |
| 206439 · 002 · RLD | capsule, extended release, oral | 10MG;28MG | 5 Dec 2029 |
| 206439 · 003 · RLD | capsule, extended release, oral | 10MG;7MG | 5 Dec 2029 |
| 206439 · 004 · RLD | capsule, extended release, oral | 10MG;21MG | 5 Dec 2029 |