FDA Orange Book · active-ingredient family
Paliperidone palmitate
Paliperidone palmitate is approved in 3 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:ERZOFRI · NDA 216352
3
Brand (NDA)
0
Generics (ANDA)
8
Listed patents
0
Exclusivity periods
Brand (NDA) products · suspension, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ERZOFRIRLD×6 | LUYE INNOMIND PHARMA | NDA 216352 | — | Jul 26, 2024 | |
| INVEGA HAFYERARLD×6 | JANSSEN PHARMS | NDA 207946 | — | Aug 30, 2021 | |
| INVEGA SUSTENNARLD×5 | JANSSEN PHARMS | NDA 022264 | — | Jul 31, 2009 |
Listed patents (8)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9439906 | Jan 26, 2031 | in 4 yr 8 mo | U-2758 |
| 10143693 | Apr 05, 2036 | in 9 yr 11 mo | U-2458 |
| 12128049 | Oct 26, 2038 | in 12 yr 6 mo | U-3968 |
| 11666573 | Sep 24, 2039 | in 13 yr 6 mo | U-3968 |
| 11324751 | May 07, 2041 | in 15 yr 1 mo | U-3359 |
| 11304951 | May 07, 2041 | in 15 yr 1 mo | U-3349 |
| 12208100 | May 07, 2041 | in 15 yr 1 mo | U-3359 |
| 11666697 | Nov 24, 2041 | in 15 yr 8 mo | U-3626 |
Paliperidone palmitate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
