EMPAVELI Drug Patent Profile

When do Empaveli patents expire, and when can generic versions of Empaveli launch?

Empaveli is a drug marketed by Apellis Pharms and is included in one NDA. There are eight patents protecting this drug.

This drug has one hundred and thirty-six patent family members in twenty-four countries.

The generic ingredient in EMPAVELI is pegcetacoplan. One supplier is listed for this compound. Additional details are available on the pegcetacoplan profile page.

DrugPatentWatch^® Generic Entry Outlook for Empaveli

Empaveli will be eligible for patent challenges on May 14, 2025. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 9, 2038. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for EMPAVELI

International Patents:	136
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for EMPAVELI
What excipients (inactive ingredients) are in EMPAVELI?	EMPAVELI excipients list
DailyMed Link:	EMPAVELI at DailyMed

See drug prices for EMPAVELI

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

NDA:

215014

Dosage:

SOLUTION;SUBCUTANEOUS

^*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.

Pharmacology for EMPAVELI

Drug Class	Complement Inhibitor
Mechanism of Action	Complement Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for EMPAVELI

L04AA	Selective immunosuppressants
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for EMPAVELI

EMPAVELI is protected by eleven US patents and two FDA Regulatory Exclusivities.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting EMPAVELI

FDA Regulatory Exclusivity protecting EMPAVELI

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
Apellis Pharms	EMPAVELI	pegcetacoplan	SOLUTION;SUBCUTANEOUS	215014-001	May 14, 2021		RX	Yes	Yes			Y	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
Apellis Pharms	EMPAVELI	pegcetacoplan	SOLUTION;SUBCUTANEOUS	215014-001	May 14, 2021		RX	Yes	Yes				Y

EU/EMA Drug Approvals for EMPAVELI

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 EMPAVELI

When does loss-of-exclusivity occur for EMPAVELI?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

European Patent Office

Israel

Japan

Mexico

Russian Federation

South Korea

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering EMPAVELI around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2377877	Analogues puissants de la compstatine (Potent compstatin analogs)
World Intellectual Property Organization (WIPO)	2018187813
Russian Federation	2474586	ЭФФЕКТИВНЫЕ АНАЛОГИ КОМПСТАТИНА (EFFICIENT COMPSTATIN ANALOGUES)
Brazil	112015011244	ANÁLOGOS DE COMPSTATINA DE AÇÃO PROLONGADA, MÉTODO DE FABRICAÇÃO E USO DOS MESMOS, BEM COMO COMPOSIÇÃO DE QUALIDADE FARMACÊUTICA
Poland	2920201
Japan	2006505254

Supplementary Protection Certificates for EMPAVELI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3660033	CA 2022 00023	Denmark		PRODUCT NAME: PEGCETACOPLAN; REG. NO/DATE: EU/1/21/1595 20211214
3660033	2290021-1	Sweden		PRODUCT NAME: PEGCETAKOPLAN; REG. 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
3660033	122022000034	Germany		PRODUCT NAME: PEGCETACOPLAN; REGISTRATION NO/DATE: EU/1/21/1595 20211213
3660033	2022C/522	Belgium		PRODUCT NAME: PEGCETACOPLAN; AUTHORISATION NUMBER AND DATE: EU/1/21/1595 20211214