Is there a generic for Avacopan?

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

What is the reference-listed drug for Avacopan?

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

What patents protect Avacopan?

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.

Does Avacopan have FDA marketing exclusivity?

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.

What dosage forms of Avacopan are approved?

Avacopan is approved in the following dosage form: capsule.

FDA Orange Book · active-ingredient family

Avacopan

Avacopan: 1 brand, 0 generics; first approved Oct 07, 2021; on patent until Feb 03, 2031.

On patent2 exclusivity periods

Generic status & protection

Protected until Feb 03, 2031 (earliest listed patent expiry).

Earliest patent expiry Feb 03, 2031Latest exclusivity ends Oct 07, 2028

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Feb 03, 2031

in 4 yr 8 mo

Originator applications

Brand (NDA) products

TAVNEOSRLDRS

CHEMOCENTRYXNDA 2144872021

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	CAPSULE	ORAL	Rx	—

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Hatch-Waxman

Marketing exclusivity

Marketing exclusivity (2)

NCENew chemical entity exclusivity (5 years)
Oct 07, 2026
in 3 mo
ODE-377Orphan-drug exclusivity (7 years)
Oct 07, 2028
in 2 yr 3 mo

Orange Book patent file

Listed patents

Listed patents (4)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8445515	Feb 03, 2031	in 4 yr 8 mo	SubstanceProduct
8906938	Jan 06, 2034	in 7 yr 7 mo	SubstanceProduct
11603356	Nov 27, 2039	in 13 yr 7 mo	SubstanceProductU-3558
11951214	Nov 27, 2039	in 13 yr 7 mo	Product

FDA approval span

Approval history

First approval

Oct 07, 2021

4 yr 10 mo ago

Most recent approval

Oct 07, 2021

4 yr 10 mo ago

All 1 application were approved in 2021.

Brand (NDA) 1100%

Generic (ANDA) 00%

Avacopan — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Related FDA reference tools

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo