FDA Orange Book · active-ingredient family
Pegcetacoplan
Pegcetacoplan is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:SYFOVRE · NDA 217171
2
Brand (NDA)
0
Generics (ANDA)
16
Listed patents
8
Exclusivity periods
Brand (NDA) products · solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SYFOVRERLD | APELLIS PHARMS | NDA 217171 | — | Feb 17, 2023 | |
| EMPAVELIRLD | APELLIS PHARMS | NDA 215014 | — | May 14, 2021 |
Marketing exclusivity (8)
- NCENew chemical entity exclusivity (5 years)
May 14, 2026
1 mo ago
- NPNew product exclusivity (3 years)
Feb 22, 2026
4 mo ago
- I-972New indication exclusivity (3 years)
Jul 28, 2028
in 2 yr 2 mo
- M-288New use / labeling-change exclusivity (3 years)
Feb 08, 2026
4 mo ago
- NCENew chemical entity exclusivity (5 years)
May 14, 2026
1 mo ago
- ODE-351Orphan-drug exclusivity (7 years)
May 14, 2028
in 1 yr 11 mo
- ODE-533Orphan-drug exclusivity (7 years)
Jul 28, 2032
in 6 yr 2 mo
- ODE-539Orphan-drug exclusivity (7 years)
Jul 28, 2032
in 6 yr 2 mo
Listed patents (16)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9056076 | Oct 25, 2026 | in 4 mo | U-3540 |
| 8168584 | Apr 07, 2027 | in 10 mo | U-3540 |
| 9169307 | Nov 18, 2027 | in 1 yr 5 mo | SubstanceU-3541 |
| 7989589 | Dec 04, 2027 | in 1 yr 6 mo | Substance |
| 7888323 | Dec 04, 2027 | in 1 yr 6 mo | Substance |
| 11661441 | Jan 13, 2033 | in 6 yr 8 mo | SubstanceU-3540 |
| 10125171 | Aug 02, 2033 | in 7 yr 3 mo | Substance |
| 11292815 | Nov 15, 2033 | in 7 yr 6 mo | SubstanceProductU-3540 |
| 10875893 | Nov 15, 2033 | in 7 yr 6 mo | SubstanceU-3540 |
| 10035822 | Nov 15, 2033 | in 7 yr 6 mo | Substance |
| 12528836 | Oct 07, 2036 | in 10 yr 5 mo | U-4394 |
| 11903994 | Feb 22, 2037 | in 10 yr 10 mo | U-3826 |
| 11040107 | Apr 09, 2038 | in 12 yr | ProductU-3172 |
| 11844841 | Dec 09, 2038 | in 12 yr 8 mo | ProductU-4241 |
| 12458695 | Dec 14, 2038 | in 12 yr 8 mo | Product |
| 12290566 | Dec 14, 2038 | in 12 yr 8 mo | ProductU-4174 |
Pegcetacoplan — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
