Pegcetacoplan - Generic Drug Details

What are the generic sources for pegcetacoplan and what is the scope of patent protection?

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

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

One supplier is listed for this compound.

Summary for pegcetacoplan

International Patents:	190
US Patents:	13
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	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			Y	Y
Apellis Pharms	SYFOVRE	pegcetacoplan	SOLUTION;INTRAVITREAL	217171-001	Feb 17, 2023		RX	Yes	Yes
Apellis Pharms	SYFOVRE	pegcetacoplan	SOLUTION;INTRAVITREAL	217171-001	Feb 17, 2023		RX	Yes	Yes
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

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
European Patent Office	4105224	ANALOGUES DE LA COMPSTATINE À LONGUE DURÉE D'ACTION ET LEURS UTILISATIONS (LONG-ACTING COMPSTATIN ANALOGS AND USES THEREOF)
Japan	2009511496
China	110831544	给药方案以及相关组合物和方法 (DOSING REGIMENS AND RELATED COMPOSITIONS AND METHODS)
Israel	269844	משטרי מינון ותכשירים קשורים ושיטות (Dosing regimens 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)
Japan	2013531030
European Patent Office	3359555	RÉGIMES POSOLOGIQUES (DOSING REGIMENS)

Supplementary Protection Certificates for pegcetacoplan

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3660033	122022000034	Germany		PRODUCT NAME: PEGCETACOPLAN; REGISTRATION NO/DATE: EU/1/21/1595 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
3660033	CA 2022 00023	Denmark		PRODUCT NAME: PEGCETACOPLAN; REG. NO/DATE: EU/1/21/1595 20211214
3660033	PA2022010	Lithuania		PRODUCT NAME: PEGCETACOPLANAS ; REGISTRATION NO/DATE: EU/1/21/1595 20211213
3660033	2022C/522	Belgium		PRODUCT NAME: PEGCETACOPLAN; AUTHORISATION NUMBER AND DATE: EU/1/21/1595 20211214
3660033	2022017	Norway		PRODUCT NAME: PEGCETACOPLAN; REG. NO/DATE: EU/1/21/1595 20211216