small molecule

EMPAVELI

PEGCETACOPLAN

Loss of exclusivityDecember 2038latest FDA-listed patent expiry
CompanyApellis PharmaceuticalsView the full company profile on CliffBio

Drug detail

Brand nameEMPAVELI
Active ingredientPEGCETACOPLAN
Strength1080MG/20ML (54MG/ML)
Dosage formSOLUTION
RouteSUBCUTANEOUS
ModalitySmall molecule
FDA approvalMay 2021
Marketing statusRX

Listed patents

PatentExpiresType
12290566December 2038product
11844841December 2038product
11040107April 2038product
10875893November 2033substance
11292815November 2033substance, product
10035822November 2033substance
10125171August 2033substance
11661441January 2033substance
7989589December 2027substance
7888323December 2027substance
9169307November 2027substance

Regulatory exclusivity

CodeExpires
ODE-533July 2032
ODE-539July 2032
I-972July 2028
ODE-351May 2028
NCEMay 2026
M-288February 2026

Source: FDA Orange Book, layered on the CliffBio company graph. Cliff dates are the latest FDA-listed patent expiry; estimates are projections, not legal advice.

EMPAVELI patent cliff — loss of exclusivity December 2038 | CliffBio