pimavanserin tartrate · Acadia Pharms Inc · NDA 207318, 210793
Nuplazid
Earliest generic entry, as listed · earliest of 2 marketed strengths
23 Sep 2037
Other strengths are listed to 27 Feb 2039.
Blocked by patent: US 10517860, US 10953000.
Listed patents · 16 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10449185 | — | 27 Feb 2039 |
| US 10646480 | — | 27 Feb 2039 |
| US 10849891 | — | 27 Feb 2039 |
| US 11452721 | — | 27 Feb 2039 |
| US 10449185 | product | 27 Aug 2038 |
| US 10646480 | product | 27 Aug 2038 |
| US 10849891 | product, use U-1974 | 27 Aug 2038 |
| US 11452721 | product | 27 Aug 2038 |
| US 10517860 | — | 23 Sep 2037 |
| US 10953000 | — | 23 Sep 2037 |
| US 10517860 | use U-1974 | 23 Mar 2037 |
| US 10953000 | use U-1974 | 23 Mar 2037 |
| US 7601740 | — | 29 Oct 2030 |
| US 7601740 | substance, product | 29 Apr 2030 |
| US 7732615 | — | 3 Dec 2028 |
| US 7732615 | substance, product | 3 Jun 2028 |
Exclusivities · 2 unexpired
| PED | pediatric (6 months added) | 27 Oct 2029 |
| M-14 | miscellaneous (3 years) | 27 Apr 2029 |
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 tentatively approved · 210793-0012 Sep 2026
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 207318 · 001 · RLD · discontinued | tablet, oral | EQ 17MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 29 Oct 2030 |
| 207318 · 002 · RLD | tablet, oral | EQ 10MG BASE | 23 Sep 2037 |
| 210793 · 001 · RLD | capsule, oral | EQ 34MG BASE | 27 Feb 2039 |
Expired or delisted (1)
- US 7659285 · use U-1844 · 24 Aug 2026