Last Updated: October 26, 2026

Pegcetacoplan - Generic Drug Details

Name: pegcetacoplan Generic Launch, Drug Patent, and Exclusivity Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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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 sixteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for pegcetacoplan

International Patents:	225
US Patents:	16
Tradenames:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Clinical Trials:	24
What excipients (inactive ingredients) are in pegcetacoplan?	pegcetacoplan excipients list
DailyMed Link:	pegcetacoplan at DailyMed

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

Generic Entry Dates for pegcetacoplan^: ⤷ Start Trial* Constraining patent/regulatory exclusivity: 10,035,822 Dosage: SOLUTION;SUBCUTANEOUS
Generic Entry Dates for pegcetacoplan^: ⤷ Start Trial* Constraining patent/regulatory exclusivity: 10,035,822 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
Roswell Park Cancer Institute	PHASE1
Apellis Pharmaceuticals, Inc.	PHASE3
Apellis Pharmaceuticals, Inc.	PHASE2

See all pegcetacoplan clinical trials

Pharmacology for pegcetacoplan

Drug Class	Complement Inhibitor
Mechanism of Action	Complement Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for pegcetacoplan

US Patents and Regulatory Information for pegcetacoplan

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Glossary

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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	11,661,441	⤷ Start Trial		Y		⤷ Start Trial
Apellis Pharms	EMPAVELI	pegcetacoplan	SOLUTION;SUBCUTANEOUS	215014-001	May 14, 2021		RX	Yes	Yes	11,292,815	⤷ Start Trial	Y	Y		⤷ Start Trial
Apellis Pharms	SYFOVRE	pegcetacoplan	SOLUTION;INTRAVITREAL	217171-001	Feb 17, 2023		RX	Yes	Yes	10,035,822	⤷ Start Trial		Y		⤷ Start Trial
Apellis Pharms	SYFOVRE	pegcetacoplan	SOLUTION;INTRAVITREAL	217171-001	Feb 17, 2023		RX	Yes	Yes	7,989,589	⤷ Start Trial		Y		⤷ Start Trial
Apellis Pharms	SYFOVRE	pegcetacoplan	SOLUTION;INTRAVITREAL	217171-001	Feb 17, 2023		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Apellis Pharms	SYFOVRE	pegcetacoplan	SOLUTION;INTRAVITREAL	217171-001	Feb 17, 2023		RX	Yes	Yes	11,292,815	⤷ Start Trial	Y	Y		⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for pegcetacoplan

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apellis Pharms	SYFOVRE	pegcetacoplan	SOLUTION;INTRAVITREAL	217171-001	Feb 17, 2023	9,056,076	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for pegcetacoplan

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Swedish Orphan Biovitrum AB (publ)	Aspaveli	pegcetacoplan	EMEA/H/C/005553Aspaveli 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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for pegcetacoplan

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Country	Patent Number	Title	Estimated Expiration
Australia	2013344462		⤷ Start Trial
Australia	2018247243		⤷ Start Trial
Australia	2020260435		⤷ Start Trial
Australia	2023200929		⤷ Start Trial
Australia	2025201748		⤷ Start Trial
Brazil	112015011244		⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for pegcetacoplan

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3660033	CR 2022 00023	Denmark	⤷ Start Trial	PRODUCT NAME: PEGCETACOPLAN; REG. NO/DATE: EU/1/21/1595 20211214
3660033	PA2022010,C3660033	Lithuania	⤷ Start Trial	PRODUCT NAME: PEGCETACOPLANAS ; REGISTRATION NO/DATE: EU/1/21/1595 20211213
3660033	202240020	Slovenia	⤷ Start Trial	PRODUCT NAME: PEGCETACOPLAN; NATIONAL AUTHORISATION NUMBER: EU/1/21/1595; DATE OF NATIONAL AUTHORISATION: 20211213; AUTHORITY FOR NATIONAL AUTHORISATION: EU
3660033	PA2022010	Lithuania	⤷ Start Trial	PRODUCT NAME: PEGCETACOPLANAS ; REGISTRATION NO/DATE: EU/1/21/1595 20211213
3660033	LUC00265	Luxembourg	⤷ Start Trial	PRODUCT NAME: PEGCETACOPLAN; AUTHORISATION NUMBER AND DATE: EU/1/21/1595 20211214
3660033	2022017	Norway	⤷ Start Trial	PRODUCT NAME: PEGCETACOPLAN; REG. NO/DATE: EU/1/21/1595 20211216
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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