PEGCETACOPLAN - Generic Drug Details

What are the generic drug sources for pegcetacoplan and what is the scope of freedom to operate?

Pegcetacoplan is the generic ingredient in two branded drugs marketed by Apellis Pharms and is included in two NDAs. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Pegcetacoplan has one hundred and seventy-three patent family members in twenty-five countries.

One supplier is listed for this compound.

Summary for PEGCETACOPLAN

International Patents:	173
US Patents:	12
Tradenames:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Clinical Trials:	19
What excipients (inactive ingredients) are in PEGCETACOPLAN?	PEGCETACOPLAN excipients list
DailyMed Link:	PEGCETACOPLAN at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for PEGCETACOPLAN

Dosage:

SOLUTION;SUBCUTANEOUS

Dosage:

SOLUTION;INTRAVITREAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for PEGCETACOPLAN

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Swedish Orphan Biovitrum	Phase 2
Swedish Orphan Biovitrum	Phase 3
Roswell Park Cancer Institute	Phase 2

See all PEGCETACOPLAN clinical trials

Pharmacology for PEGCETACOPLAN

Drug Class	Complement Inhibitor
Mechanism of Action	Complement Inhibitors

US Patents and Regulatory Information for PEGCETACOPLAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apellis Pharms	SYFOVRE	pegcetacoplan	SOLUTION;INTRAVITREAL	217171-001	Feb 17, 2023		RX	Yes	Yes				Y
Apellis Pharms	SYFOVRE	pegcetacoplan	SOLUTION;INTRAVITREAL	217171-001	Feb 17, 2023		RX	Yes	Yes
Apellis Pharms	EMPAVELI	pegcetacoplan	SOLUTION;SUBCUTANEOUS	215014-001	May 14, 2021		RX	Yes	Yes
Apellis Pharms	EMPAVELI	pegcetacoplan	SOLUTION;SUBCUTANEOUS	215014-001	May 14, 2021		RX	Yes	Yes				Y
Apellis Pharms	EMPAVELI	pegcetacoplan	SOLUTION;SUBCUTANEOUS	215014-001	May 14, 2021		RX	Yes	Yes
Apellis Pharms	EMPAVELI	pegcetacoplan	SOLUTION;SUBCUTANEOUS	215014-001	May 14, 2021		RX	Yes	Yes				Y

EU/EMA Drug Approvals for PEGCETACOPLAN

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Swedish Orphan Biovitrum AB (publ)	Aspaveli	pegcetacoplan	EMEA/H/C/005553 Aspaveli is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who are anaemic after treatment with a C5 inhibitor for at least 3 months.	Authorised	no	no	yes	2021-12-13

International Patents for PEGCETACOPLAN

Country	Patent Number	Title	Estimated Expiration
Japan	2016028081	眼の障害のための注射可能複合療法 (INJECTABLE COMBINATION THERAPY FOR EYE DISORDERS)
Australia	2018247243	Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods
Canada	2625206	COMPSTATINE ET ANALOGUES DE CELLE-CI POUR DES TROUBLES DE LA VUE (COMPSTATIN AND ANALOGS THEREOF FOR EYE DISORDERS)
Australia	2020260435	Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods
Norway	2022017
Poland	1993673

Supplementary Protection Certificates for PEGCETACOPLAN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3660033	2022C/522	Belgium		PRODUCT NAME: PEGCETACOPLAN; AUTHORISATION NUMBER AND DATE: EU/1/21/1595 20211214
3660033	LUC00265	Luxembourg		PRODUCT NAME: PEGCETACOPLAN; AUTHORISATION NUMBER AND DATE: EU/1/21/1595 20211214
3660033	PA2022010	Lithuania		PRODUCT NAME: PEGCETACOPLANAS ; REGISTRATION NO/DATE: EU/1/21/1595 20211213
3660033	C202230025	Spain		PRODUCT NAME: PEGCETACOPLAN; NATIONAL AUTHORISATION NUMBER: EU/1/21/1595; DATE OF AUTHORISATION: 20211213; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1595; DATE OF FIRST AUTHORISATION IN EEA: 20211213
3660033	C03660033/01	Switzerland		PRODUCT NAME: PEGCETACOPLAN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68674 23.03.2023
3660033	2290021-1	Sweden		PRODUCT NAME: PEGCETAKOPLAN; REG. NO/DATE: EU/1/21/1595 20211214