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TAVNEOS Drug Patent Profile

Which patents cover Tavneos, and when can generic versions of Tavneos launch?

Tavneos is a drug marketed by Chemocentryx and is included in one NDA. There are three patents protecting this drug.

This drug has seventy-seven patent family members in thirty-five countries.

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

DrugPatentWatch^® Generic Entry Outlook for Tavneos

Tavneos will be eligible for patent challenges on October 7, 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 February 3, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for TAVNEOS

International Patents:	77
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	27
Patent Applications:	86
Drug Prices:	Drug price information for TAVNEOS
What excipients (inactive ingredients) are in TAVNEOS?	TAVNEOS excipients list
DailyMed Link:	TAVNEOS at DailyMed

See drug prices for TAVNEOS

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

NDA:

214487

Dosage:

CAPSULE;ORAL

^*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 TAVNEOS

Drug Class	Complement 5a Receptor Antagonist
Mechanism of Action	Complement 5a Receptor Antagonists Cytochrome P450 3A4 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for TAVNEOS

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

L04AJ	Complement inhibitors
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for TAVNEOS

TAVNEOS is protected by three 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 TAVNEOS

FDA Regulatory Exclusivity protecting TAVNEOS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chemocentryx	TAVNEOS	avacopan	CAPSULE;ORAL	214487-001	Oct 7, 2021		RX	Yes	Yes			Y	Y
Chemocentryx	TAVNEOS	avacopan	CAPSULE;ORAL	214487-001	Oct 7, 2021		RX	Yes	Yes
Chemocentryx	TAVNEOS	avacopan	CAPSULE;ORAL	214487-001	Oct 7, 2021		RX	Yes	Yes			Y	Y
Chemocentryx	TAVNEOS	avacopan	CAPSULE;ORAL	214487-001	Oct 7, 2021		RX	Yes	Yes			Y	Y
Chemocentryx	TAVNEOS	avacopan	CAPSULE;ORAL	214487-001	Oct 7, 2021		RX	Yes	Yes

EU/EMA Drug Approvals for TAVNEOS

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Vifor Fresenius Medical Care Renal Pharma France	Tavneos	avacopan	EMEA/H/C/005523 Tavneos, in combination with a rituximab or cyclophosphamide regimen, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA).	Authorised	no	no	yes	2022-01-11

International Patents for TAVNEOS

When does loss-of-exclusivity occur for TAVNEOS?

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

Argentina

Australia

Brazil

Canada

China

Colombia

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

France

Hong Kong

Hungary

Israel

Japan

Jordan

Lithuania

Mexico

Morocco

Netherlands

New Zealand

Norway

Poland

Portugal

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

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 TAVNEOS around the world.

Country	Patent Number	Title	Estimated Expiration
Colombia	6400172	C5AR ANTAGONISTAS
Brazil	PI0923384	composto, composição farmacêutica, e, métodos para tratar um mamífero, e para inibir quimiotaxia celular
South Korea	20220098754	보체 성분 C5a 수용체의 비정질 형태
Eurasian Patent Organization	201101009	АНТАГОНИСТЫ C5aR
South Korea	101680818

Supplementary Protection Certificates for TAVNEOS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2381778	22C1020	France		PRODUCT NAME: AVACOPAN ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/21/1605 20220119
2381778	C02381778/01	Switzerland		FORMER OWNER: CHEMOCENTRYX, INC., US
2381778	C202230016	Spain		PRODUCT NAME: AVACOPAN Y SALES FARMACEUTICAMENTE ACEPTABLES DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/21/1605; DATE OF AUTHORISATION: 20220111; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1605; DATE OF FIRST AUTHORISATION IN EEA: 20220111
2381778	301166	Netherlands		PRODUCT NAME: AVACOPAN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/21/1605 20220119
2381778	CA 2022 00022	Denmark		PRODUCT NAME: AVACOPAN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REG. NO/DATE: EU/1/21/1605 20220119