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AVYCAZ

NDA

AVIBACTAM SODIUM; CEFTAZIDIME | N206494 | ABBVIE INC

1 strength7 unique patents1 unique exclusivity

Patent Timeline

7 unique patents, 1 exclusivity by expiration date

Expired (1)Expiring < 1yr (1)Active (5)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

Today

Jan. 7, 2026

Nov. 12, 2026

Aug. 12, 2031

Oct. 8, 2030

Jun. 15, 2032

Jun. 15, 2032

Jun. 15, 2032

NPP

Jan. 26, 2027

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

1 case on OB patents (1 active) from PACER

Case	Court	Filed	Status	Judge
AbbVie Inc. et al v. Fresenius Kabi USA, LLC et al 3:2025cv01595 7 patentsANDA 219325ceftazidime and avibactam	D.N.J.	2025-03-03	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

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$2995.67

Highest Price

$3965.80

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00456-2700-10AVYCAZ INJ	$3965.80	FSS	Abbvie US LLC	07/31/2030
00456-2700-10AVYCAZ INJ	$2995.67	Big4	Abbvie US LLC	07/31/2030

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Avycaz (2024)

Total Spending

$19.5M

Total Claims

4,263

Beneficiaries

1,123

Avg Cost/Unit

$64.78

Spending Trend

$8.1M(2019)→$6.5M(2020)→$15.5M(2021)→$12.7M(2022)→$15.6M(2023)→$19.5M(2024)

YoY Change:+22.9%

5yr CAGR:+21.3%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

Medicare Part B Spending

CMS physician-administered drug spending for Avycaz (2024)

Total Spending

$303K

Total Claims

351

Beneficiaries

ASP Price

$97.92

Spending Trend

$800K(2019)→$745K(2020)→$1.4M(2021)→$499K(2022)→$255K(2023)→$303K(2024)

YoY Change:+7.5%

5yr CAGR:+4.0%

HCPCS: J0714 — Injection, ceftazidime and avibactam, 0.5 g/0.125 g

Source: CMS Medicare Part B Spending by Drug (2024). Shows physician-administered drug costs.

Approval Letters

12 letters from Drugs@FDA

Date	Submission	Document
May 5, 2025	SUPPL -14	View Letter (PDF)
Mar 4, 2025	SUPPL -13	View Letter (PDF)
Jan 29, 2024	SUPPL -12	View Letter (PDF)
Dec 22, 2022	SUPPL -11	View Letter (PDF)
Dec 9, 2020	SUPPL -7	View Letter (PDF)
Mar 15, 2019	SUPPL -6	View Letter (PDF)
Mar 15, 2019	SUPPL -5	View Letter (PDF)
Feb 2, 2018	SUPPL -4	View Letter (PDF)
Jan 30, 2017	SUPPL -3	View Letter (PDF)
Jun 23, 2016	SUPPL -2	View Letter (PDF)
Sep 4, 2015	SUPPL -1	View Letter (PDF)
Feb 27, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 0.5GM BASE;2GM/VIAL

RLD

7 patents1 exclusivity▴

POWDER;INTRAVENOUS | Approved: Feb 25, 2015

Patents (7) · 4 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7112592	Jan 7, 2026	—	Yes	Yes		—
7612087	Nov 12, 2026	—	—	Yes	—	—
8471025	Aug 12, 2031	—	Yes	—	—	—
8835455	Oct 8, 2030	—	—	Yes	—	—
8969566	Jun 15, 2032	—	Yes	—	—	—
9284314	Jun 15, 2032	—	Yes	—	—	—
9695122	Jun 15, 2032	—	Yes	—	—	—

Exclusivities (1)

Code	Date	Status
NPP	Jan 26, 2027	< 1 year