Orange Book product · Brand (NDA)
EMPAVELI
PEGCETACOPLAN
At a glance
May 14, 2021
Approved
Brand (NDA)
Application
Not listed
TE code
27
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 14, 2021
5 yr 2 mo ago
Exclusivity ends · M-288
New use / labeling-change exclusivity (3 years)
Feb 08, 2026
4 mo ago
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
May 14, 2026
1 mo ago
Today
Patent 9169307 expires
Listed drug substance patent expiration.
Nov 18, 2027
in 1 yr 5 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
Exclusivity ends · ODE-351
Orphan-drug exclusivity (7 years)
May 14, 2028
in 1 yr 11 mo
Exclusivity ends · I-972
New indication exclusivity (3 years)
Jul 28, 2028
in 2 yr 2 mo
Exclusivity ends · ODE-533
Orphan-drug exclusivity (7 years)
Jul 28, 2032
in 6 yr 2 mo
Exclusivity ends · ODE-539
Orphan-drug exclusivity (7 years)
Jul 28, 2032
in 6 yr 2 mo
Patent 11661441 expires
Listed drug substance patent expiration.
Jan 13, 2033
in 6 yr 8 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 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 11292815 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 11292815 expires
Listed drug substance patent expiration.
Nov 15, 2033
in 7 yr 6 mo
Patent 11040107 expires
Listed drug product patent expiration.
Apr 09, 2038
in 12 yr
Patent 11040107 expires
Listed drug product patent expiration.
Apr 09, 2038
in 12 yr
Patent 11040107 expires
Listed drug product patent expiration.
Apr 09, 2038
in 12 yr
Patent 11040107 expires
Listed drug product patent expiration.
Apr 09, 2038
in 12 yr
Patent 11844841 expires
Listed drug product patent expiration.
Dec 09, 2038
in 12 yr 8 mo
Patent 11844841 expires
Listed drug product patent expiration.
Dec 09, 2038
in 12 yr 8 mo
Patent 11844841 expires
Listed drug product patent expiration.
Dec 09, 2038
in 12 yr 8 mo
Patent 11844841 expires
Listed drug product patent expiration.
Dec 09, 2038
in 12 yr 8 mo
Patent 12290566 expires
Listed drug product patent expiration.
Dec 14, 2038
in 12 yr 8 mo
Patent 12290566 expires
Listed drug product patent expiration.
Dec 14, 2038
in 12 yr 8 mo
Patent 12290566 expires
Listed drug product patent expiration.
Dec 14, 2038
in 12 yr 8 mo
Patent 12290566 expires
Listed drug product patent expiration.
Dec 14, 2038
in 12 yr 8 mo
Patent 12290566 expires
Listed drug product patent expiration.
Dec 14, 2038
in 12 yr 8 mo
Pharmaceutical detail
Active ingredient
PEGCETACOPLAN
Strength
1080MG/20ML (54MG/ML)
Dosage form
SOLUTION
Route
SUBCUTANEOUS
TE code
Not listed
Application
NDA 215014
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 (6)
- 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
- I-972New indication exclusivity (3 years)
Jul 28, 2028
in 2 yr 2 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 (27)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9169307 | Nov 18, 2027 | in 1 yr 5 mo | SubstanceU-4244 |
| 9169307 | Nov 18, 2027 | in 1 yr 5 mo | SubstanceU-3123 |
| 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-4242 |
| 11661441 | Jan 13, 2033 | in 6 yr 8 mo | SubstanceU-3124 |
| 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-4242 |
| 10875893 | Nov 15, 2033 | in 7 yr 6 mo | SubstanceU-3124 |
| 11292815 | Nov 15, 2033 | in 7 yr 6 mo | SubstanceProductU-3124 |
| 11292815 | Nov 15, 2033 | in 7 yr 6 mo | SubstanceProductU-3354 |
| 11292815 | Nov 15, 2033 | in 7 yr 6 mo | SubstanceProductU-4242 |
| 11292815 | Nov 15, 2033 | in 7 yr 6 mo | SubstanceProductU-4243 |
| 11040107 | Apr 09, 2038 | in 12 yr | ProductU-3172 |
| 11040107 | Apr 09, 2038 | in 12 yr | ProductU-3174 |
| 11040107 | Apr 09, 2038 | in 12 yr | ProductU-3173 |
| 11040107 | Apr 09, 2038 | in 12 yr | ProductU-4241 |
| 11844841 | Dec 09, 2038 | in 12 yr 8 mo | ProductU-4241 |
| 11844841 | Dec 09, 2038 | in 12 yr 8 mo | ProductU-3172 |
| 11844841 | Dec 09, 2038 | in 12 yr 8 mo | ProductU-3174 |
| 11844841 | Dec 09, 2038 | in 12 yr 8 mo | ProductU-3173 |
| 12290566 | Dec 14, 2038 | in 12 yr 8 mo | ProductU-4174 |
| 12290566 | Dec 14, 2038 | in 12 yr 8 mo | ProductU-4175 |
| 12290566 | Dec 14, 2038 | in 12 yr 8 mo | ProductU-4239 |
| 12290566 | Dec 14, 2038 | in 12 yr 8 mo | ProductU-4238 |
| 12290566 | Dec 14, 2038 | in 12 yr 8 mo | ProductU-4240 |
