FDA Orange Book · active-ingredient family
Pimavanserin tartrate
Pimavanserin tartrate is approved as 2 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:NUPLAZID · NDA 210793
2
Brand (NDA)
3
Generics (ANDA)
17
Listed patents
6
Exclusivity periods
Brand (NDA) products · capsule, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NUPLAZIDRLD | ACADIA PHARMS INC | NDA 210793 | — | Jun 28, 2018 | |
| NUPLAZIDRLD×2 | ACADIA PHARMS INC | NDA 207318 | — | Jun 28, 2018 |
Generic (ANDA) products (3)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PIMAVANSERIN | MSN | ANDA 214925 | — | Jan 16, 2024 | |
| PIMAVANSERIN | ZYDUS | ANDA 214493 | — | Jan 16, 2024 | |
| PIMAVANSERIN | ZYDUS | ANDA 214502 | — | Jan 16, 2024 |
Marketing exclusivity (6)
- M-14New use / labeling-change exclusivity (3 years)
Apr 27, 2029
in 2 yr 11 mo
- PEDPediatric exclusivity (adds 6 months)
Oct 27, 2029
in 3 yr 5 mo
- M-14New use / labeling-change exclusivity (3 years)
Apr 27, 2029
in 2 yr 11 mo
- PEDPediatric exclusivity (adds 6 months)
Oct 27, 2029
in 3 yr 5 mo
- M-14New use / labeling-change exclusivity (3 years)
Apr 27, 2029
in 2 yr 11 mo
- PEDPediatric exclusivity (adds 6 months)
Oct 27, 2029
in 3 yr 5 mo
Listed patents (17)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7659285 | Aug 24, 2026 | in 2 mo | U-1844 |
| 7732615 | Jun 03, 2028 | in 2 yr | SubstanceProduct |
| 7732615*PED | Dec 03, 2028 | in 2 yr 6 mo | |
| 7601740 | Apr 29, 2030 | in 3 yr 11 mo | SubstanceProduct |
| 7601740*PED | Oct 29, 2030 | in 4 yr 5 mo | |
| 10517860 | Mar 23, 2037 | in 10 yr 11 mo | U-1974 |
| 10953000 | Mar 23, 2037 | in 10 yr 11 mo | U-1974 |
| 10953000*PED | Sep 23, 2037 | in 11 yr 5 mo | |
| 10517860*PED | Sep 23, 2037 | in 11 yr 5 mo | |
| 10849891 | Aug 27, 2038 | in 12 yr 4 mo | ProductU-1974 |
| 11452721 | Aug 27, 2038 | in 12 yr 4 mo | Product |
| 10449185 | Aug 27, 2038 | in 12 yr 4 mo | Product |
| 10646480 | Aug 27, 2038 | in 12 yr 4 mo | Product |
| 10449185*PED | Feb 27, 2039 | in 12 yr 11 mo | |
| 10646480*PED | Feb 27, 2039 | in 12 yr 11 mo | |
| 10849891*PED | Feb 27, 2039 | in 12 yr 11 mo | |
| 11452721*PED | Feb 27, 2039 | in 12 yr 11 mo |
Pimavanserin tartrate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
