PEGCETACOPLAN - Generic Drug Details

What are the generic drug 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 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	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	SYFOVRE	pegcetacoplan	SOLUTION;INTRAVITREAL	217171-001	Feb 17, 2023		RX	Yes	Yes				Y
Apellis Pharms	EMPAVELI	pegcetacoplan	SOLUTION;SUBCUTANEOUS	215014-001	May 14, 2021		RX	Yes	Yes			Y
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

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
Canada	3059304	SCHEMAS POSOLOGIQUES ET COMPOSITIONS ET PROCEDES ASSOCIES (DOSING REGIMENS AND RELATED COMPOSITIONS AND METHODS)
Portugal	1960422
Japan	2013177403	STRONG COMPSTATIN ANALOG
Cyprus	1113441
Canada	2502690	ANALOGUES DE COMPSTATINE A ACTIVITE AMELIOREE (COMPSTATIN ANALOGS WITH IMPROVED ACTIVITY)
Canada	2631443	ANALOGUES PUISSANTS DE LA COMPSTATINE (POTENT COMPSTATIN ANALOGS)

Supplementary Protection Certificates for PEGCETACOPLAN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3660033	2022017	Norway		PRODUCT NAME: PEGCETACOPLAN; REG. NO/DATE: EU/1/21/1595 20211216
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	22C1025	France		PRODUCT NAME: PEGCETACOPLAN; REGISTRATION NO/DATE: EU/1/21/1595 20211214
3660033	301178	Netherlands		PRODUCT NAME: PEGCETACOPLAN; REGISTRATION NO/DATE: EU/1/21/1595 20211214
3660033	LUC00265	Luxembourg		PRODUCT NAME: PEGCETACOPLAN; AUTHORISATION NUMBER AND DATE: EU/1/21/1595 20211214