AVACOPAN - Generic Drug Details

What are the generic drug sources for avacopan and what is the scope of freedom to operate?

Avacopan is the generic ingredient in one branded drug marketed by Chemocentryx and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Avacopan has one hundred and eight patent family members in thirty-seven countries.

One supplier is listed for this compound.

Summary for AVACOPAN

International Patents:	108
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	27
Clinical Trials:	4
Patent Applications:	150
What excipients (inactive ingredients) are in AVACOPAN?	AVACOPAN excipients list
DailyMed Link:	AVACOPAN at DailyMed

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

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.

Recent Clinical Trials for AVACOPAN

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Amgen	Phase 4
Medpace, Inc.	Phase 2
ChemoCentryx	Phase 2

See all AVACOPAN clinical trials

Pharmacology for AVACOPAN

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

Anatomical Therapeutic Chemical (ATC) Classes for AVACOPAN

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 AVACOPAN

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

EU/EMA Drug Approvals for AVACOPAN

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 AVACOPAN

Country	Patent Number	Title	Estimated Expiration
Spain	2734746
Japan	6438086
Mexico	2022005406	FORMA AMORFA DE UN RECEPTOR DE COMPONENTE C5A DE COMPLEMENTO. (AMORPHOUS FORM OF A COMPLEMENT COMPONENT C5A RECEPTOR.)

Supplementary Protection Certificates for AVACOPAN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2381778	LUC00258	Luxembourg		PRODUCT NAME: AVACOPAN ET LES SELS PHARMACEUTIQUEMENT ACCEPTABLES QUI EN DERIVENT; AUTHORISATION NUMBER AND DATE: EU/1/21/1605 20220119
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	122022000029	Germany		PRODUCT NAME: AVACOPAN; REGISTRATION NO/DATE: EU/1/21/1605 20220111