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TAVNEOS

NDA

AVACOPAN | N214487 | CHEMOCENTRYX INC

1 strength4 unique patents2 unique exclusivities

Patent Timeline

4 unique patents, 2 exclusivities by expiration date

Active (4)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

Today

Feb. 3, 2031

Jan. 6, 2034

Nov. 27, 2039

Nov. 27, 2039

NCE

Oct. 7, 2026

ODE-377

Oct. 7, 2028

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

2 cases on OB patents (2 active) from PACER

Case	Court	Filed	Status	Judge
CHEMOCENTRYX, INC. v. ANNORA PHARMA PRIVATE LIMITED et al 2:2026cv01279 2 patentsANDA 220814avacopan	D.N.J.	2026-02-09	Active	—
CHEMOCENTRYX, INC. v. ZYDUS PHARMACEUTICALS (USA) INC. et al 2:2026cv00556 2 patentsANDA 221070avacopan	D.N.J.	2026-01-16	Active	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Tavneos (2023)

Total Spending

$34.0M

Total Claims

2,233

Beneficiaries

420

Avg Cost/Unit

$85.80

Spending Trend

$196K(2021)→$11.7M(2022)→$34.0M(2023)

YoY Change:+4.8%

5yr CAGR:+1.3%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain3 active DMFs

3 active API suppliers hold Drug Master Files for this ingredient.

MAITHRI DRUGS PRIVATE LTDAVACOPAN

DMF 401592024

STHREE CHEMICALS PRIVATE LTDAVACOPAN

DMF 418072025

HETERO LABS LTDAVACOPAN

DMF 420582025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Jul 2, 2024	SUPPL -4	View Letter (PDF)
Jul 7, 2022	SUPPL -1	View Letter (PDF)
Oct 12, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10MG

RLD

4 patents2 exclusivities▴

CAPSULE;ORAL | Approved: Oct 7, 2021

Patents (4)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8445515	Feb 3, 2031	—	Yes	Yes	—	—
8906938	Jan 6, 2034	—	Yes	Yes	—	—
11603356	Nov 27, 2039	—	Yes	Yes		—
11951214	Nov 27, 2039	—	—	Yes	—	—

Exclusivities (2)

Code	Date	Status
NCE	Oct 7, 2026	< 1 year
ODE-377	Oct 7, 2028	Active