Pharsight

Empaveli is owned by Apellis Pharms.

Empaveli contains Pegcetacoplan.

Empaveli has a total of 8 drug patents out of which 0 drug patents have expired.

Empaveli was authorised for market use on 14 May, 2021.

Empaveli is available in solution;subcutaneous dosage forms.

Empaveli can be used as treatment of adult patients with paroxysmal nocturnal hemoglobinuria (pnh) by administration of 1080 mg of pegcetacoplan; treatment of adult patients with paroxysmal nocturnal hemoglobinuria (pnh) by administration of 1080 mg of pegcetacoplan every three days; treatment of adult patients with paroxysmal nocturnal hemoglobinuria (pnh) by administration of 1080 mg of pegcetacoplan twice weekly, treatment of adult patients with paroxysmal nocturnal hemoglobinuria (pnh) by administration of pegcetacoplan, treatment of adult patients with paroxysmal nocturnal hemoglobinuria (pnh) by administration of pegcetacoplan; treatment of adult patients with paroxysmal nocturnal hemoglobinuria (pnh) by administration of pegcetacoplan so as to reduce the sensitivity of cells to complement-dependent damage, treatment of adult patients with paroxysmal nocturnal hemoglobinuria (pnh) by administration of complement inhibitor pegcetacoplan.

Drug patent challenges can be filed against Empaveli from May, 2025.

The generics of Empaveli are possible to be released after 09 April, 2038.

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US9169307	APELLIS PHARMS	Potent compstatin analogs	Nov, 2027 (4 years from now)
US7888323	APELLIS PHARMS	Potent compstatin analogs	Dec, 2027 (4 years from now)
US7989589	APELLIS PHARMS	Compstatin analogs with improved activity	Dec, 2027 (4 years from now)
US10125171	APELLIS PHARMS	Cell-reactive, long-acting, or targeted compstatin analogs and uses thereof	Aug, 2033 (10 years from now)
US11292815	APELLIS PHARMS	Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods	Nov, 2033 (10 years from now)
US10875893	APELLIS PHARMS	Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods	Nov, 2033 (10 years from now)
US10035822	APELLIS PHARMS	Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods	Nov, 2033 (10 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11040107	APELLIS PHARMS	Dosing regimens and related compositions and methods	Apr, 2038 (15 years from now)

Exclusivity	Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	May 14, 2026
Orphan Drug Exclusivity (ODE)	May 14, 2028

Drugs and Companies using PEGCETACOPLAN ingredient

NCE-1 date: May, 2025

Market Authorisation Date: 14 May, 2021

Treatment: Treatment of adult patients with paroxysmal nocturnal hemoglobinuria (pnh) by administration of 1080 mg of pegcetacoplan; Treatment of adult patients with paroxysmal nocturnal hemoglobinuria (pnh) by administration of 1080 mg of pegcetacoplan every three days; Treatment of adult patients with paroxysmal nocturnal hemoglobinuria (pnh) by administration of 1080 mg of pegcetacoplan twice weekly; Treatment of adult patients with paroxysmal nocturnal hemoglobinuria (pnh) by administration of complement inhibitor pegcetacoplan; Treatment of adult patients with paroxysmal nocturnal hemoglobinuria (pnh) by administration of pegcetacoplan; Treatment of adult patients with paroxysmal nocturnal hemoglobinuria (pnh) by administration of pegcetacoplan so as to reduce the sensitivity of cells to complement-dependent damage

Dosage: SOLUTION;SUBCUTANEOUS