Orange Book product · Brand (NDA)
SYFOVRE
PEGCETACOPLAN
At a glance
Feb 17, 2023
Approved
Brand (NDA)
Application
Not listed
TE code
16
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 17, 2023
3 yr 5 mo ago
Exclusivity ends · NP
New product exclusivity (3 years)
Feb 22, 2026
4 mo ago
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
May 14, 2026
1 mo ago
Today
Patent 9056076 expires
Listed method-of-use patent (U-3540) expiration.
Oct 25, 2026
in 4 mo
Patent 8168584 expires
Listed method-of-use patent (U-3540) expiration.
Apr 07, 2027
in 10 mo
Patent 8168584 expires
Listed method-of-use patent (U-3542) expiration.
Apr 07, 2027
in 10 mo
Patent 9169307 expires
Listed drug substance patent expiration.
Nov 18, 2027
in 1 yr 5 mo
Patent 7888323 expires
Listed drug substance patent expiration.
Dec 04, 2027
in 1 yr 6 mo
Patent 7989589 expires
Listed drug substance patent expiration.
Dec 04, 2027
in 1 yr 6 mo
Patent 11661441 expires
Listed drug substance patent expiration.
Jan 13, 2033
in 6 yr 8 mo
Patent 10125171 expires
Listed drug substance patent expiration.
Aug 02, 2033
in 7 yr 3 mo
Patent 10035822 expires
Listed drug substance patent expiration.
Nov 15, 2033
in 7 yr 6 mo
Patent 10875893 expires
Listed drug substance patent expiration.
Nov 15, 2033
in 7 yr 6 mo
Patent 11292815 expires
Listed drug substance patent expiration.
Nov 15, 2033
in 7 yr 6 mo
Patent 12528836 expires
Listed method-of-use patent (U-4394) expiration.
Oct 07, 2036
in 10 yr 5 mo
Patent 11903994 expires
Listed method-of-use patent (U-3826) expiration.
Feb 22, 2037
in 10 yr 10 mo
Patent 11903994 expires
Listed method-of-use patent (U-3827) expiration.
Feb 22, 2037
in 10 yr 10 mo
Patent 11903994 expires
Listed method-of-use patent (U-3828) expiration.
Feb 22, 2037
in 10 yr 10 mo
Patent 12458695 expires
Listed drug product patent expiration.
Dec 14, 2038
in 12 yr 8 mo
Pharmaceutical detail
Active ingredient
PEGCETACOPLAN
Strength
15MG/0.1ML (15MG/0.1ML)
Dosage form
SOLUTION
Route
INTRAVITREAL
TE code
Not listed
Application
NDA 217171
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (2)
- NPNew product exclusivity (3 years)
Feb 22, 2026
4 mo ago
- NCENew chemical entity exclusivity (5 years)
May 14, 2026
1 mo ago
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 |
| 8168584 | Apr 07, 2027 | in 10 mo | U-3542 |
| 9169307 | Nov 18, 2027 | in 1 yr 5 mo | SubstanceU-3541 |
| 7888323 | Dec 04, 2027 | in 1 yr 6 mo | Substance |
| 7989589 | 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 |
| 10035822 | Nov 15, 2033 | in 7 yr 6 mo | Substance |
| 10875893 | Nov 15, 2033 | in 7 yr 6 mo | SubstanceU-3540 |
| 11292815 | Nov 15, 2033 | in 7 yr 6 mo | SubstanceProductU-3540 |
| 12528836 | Oct 07, 2036 | in 10 yr 5 mo | U-4394 |
| 11903994 | Feb 22, 2037 | in 10 yr 10 mo | U-3826 |
| 11903994 | Feb 22, 2037 | in 10 yr 10 mo | U-3827 |
| 11903994 | Feb 22, 2037 | in 10 yr 10 mo | U-3828 |
| 12458695 | Dec 14, 2038 | in 12 yr 8 mo | Product |
