Question 1

Is there a generic for Avacopan?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Avacopan. It is available as 1 brand (NDA) application.

Question 2

What is the reference-listed drug for Avacopan?

Accepted Answer

TAVNEOS (NDA 214487, CHEMOCENTRYX) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Avacopan?

Accepted Answer

The Orange Book lists 4 patents against Avacopan products, with the earliest listed expiry in 2031. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

Does Avacopan have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 2 marketing-exclusivity periods for Avacopan. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

Question 5

What dosage forms of Avacopan are approved?

Accepted Answer

Avacopan is approved in the following dosage form: capsule.

Patent	Expires	In	Type
8445515	Feb 03, 2031	in 4 yr 8 mo	SubstanceProduct
8906938	Jan 06, 2034	in 7 yr 8 mo	SubstanceProduct
11603356	Nov 27, 2039	in 13 yr 8 mo	SubstanceProductU-3558
11951214	Nov 27, 2039	in 13 yr 8 mo	Product

Avacopan

Brand (NDA) products · capsule

Marketing exclusivity (2)

Listed patents (4)

Avacopan — frequently asked questions

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