Viewing data from:

ZERBAXA

NDA

CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM | N206829 | CUBIST PHARMACEUTICALS LLC

1 strength12 unique patents2 unique exclusivities

Patent Timeline

12 unique patents, 1 exclusivity by expiration date

Active (12)TodayPED (+6 mo)Exclusivity

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

Today

Nov. 15, 2028

Nov. 28, 2034

Sep. 14, 2034

Sep. 14, 2034

Mar. 7, 2033

Sep. 14, 2034

Mar. 7, 2033

Feb. 14, 2036

Mar. 9, 2035

Sep. 14, 2034

Mar. 9, 2035

Sep. 14, 2034

NPP

Nov. 12, 2029

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

No ANDA patent litigation cases (NOS 835) matched from PACER

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

$1138.44

Highest Price

$1594.60

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
67919-0030-01ZERBAXA 1.5GM INJ	$1594.60	FSS	Merck Sharp & Dohme LLC	05/31/2030
67919-0030-01ZERBAXA 1.5GM INJ	$1138.44	Big4	Merck Sharp & Dohme LLC	05/31/2030

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

Medicare Part D Spending

CMS annual spending data for Zerbaxa (2024)

Total Spending

$18.0M

Total Claims

5,087

Beneficiaries

1,128

Avg Cost/Unit

$24.65

Spending Trend

$4.9M(2019)→$8.3M(2020)→$52K(2021)→$7.2M(2022)→$12.8M(2023)→$18.0M(2024)

YoY Change:+22.5%

5yr CAGR:+23.7%

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 Zerbaxa (2024)

Total Spending

$280K

Total Claims

499

Beneficiaries

126

ASP Price

$7.78

Spending Trend

$470K(2019)→$693K(2020)→$8K(2021)→$401K(2022)→$214K(2023)→$280K(2024)

YoY Change:+5.4%

5yr CAGR:+8.0%

HCPCS: J0695 — Injection, ceftolozane 50 mg and tazobactam 25 mg

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

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
May 13, 2026	SUPPL -23	View Letter (PDF)
Apr 22, 2022	SUPPL -12	View Letter (PDF)
Apr 22, 2022	SUPPL -11	View Letter (PDF)
Dec 17, 2019	SUPPL -9	View Letter (PDF)
Jun 5, 2019	SUPPL -8	View Letter (PDF)
Oct 28, 2016	SUPPL -3	View Letter (PDF)
Sep 6, 2016	SUPPL -2	View Letter (PDF)
May 22, 2015	SUPPL -1	View Letter (PDF)
Dec 23, 2014	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL

RLD

12 patents2 exclusivities▴

POWDER;INTRAVENOUS | Approved: Dec 19, 2014

Patents (12) · 40 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7129232Newly listed — daily FDA feed, not yet in monthly Orange Book edition	May 15, 2028PED: Nov 15, 2028	PED	Yes	Yes		—
8906898	May 28, 2034PED: Nov 28, 2034	PED	Yes	Yes	—	—
8968753Newly listed — daily FDA feed, not yet in monthly Orange Book edition	Mar 14, 2034PED: Sep 14, 2034	PED	—	—		—
9320740	Mar 14, 2034PED: Sep 14, 2034	PED	—	Yes	—	—
9724353Newly listed — daily FDA feed, not yet in monthly Orange Book edition	Sep 7, 2032PED: Mar 7, 2033	PED	—	—		—
9872906	Mar 14, 2034PED: Sep 14, 2034	PED	—	Yes	—	—
10028963Newly listed — daily FDA feed, not yet in monthly Orange Book edition	Sep 7, 2032PED: Mar 7, 2033	PED	—	—		—
10125149	Aug 14, 2035PED: Feb 14, 2036	PED	—	Yes	—	—
10376496Newly listed — daily FDA feed, not yet in monthly Orange Book edition	Sep 9, 2034PED: Mar 9, 2035	PED	—	—		—
10420841Newly listed — daily FDA feed, not yet in monthly Orange Book edition	Mar 14, 2034PED: Sep 14, 2034	PED	—	—		—
10933053Newly listed — daily FDA feed, not yet in monthly Orange Book edition	Sep 9, 2034PED: Mar 9, 2035	PED	—	—		—
11278622Newly listed — daily FDA feed, not yet in monthly Orange Book edition	Mar 14, 2034PED: Sep 14, 2034	PED	—	—		—

Exclusivities (2)

Code	Date	Status
NPPNewly listed — daily FDA feed, not yet in monthly Orange Book edition	May 12, 2029	Active
NPP*PEDNewly listed — daily FDA feed, not yet in monthly Orange Book edition	Nov 12, 2029	Active

Change History (2)

Recent changes detected for this application.

ADDED7/14/2026

Zerbaxa (ceftolozane sulfate; tazobactam sodium) gained pediatric exclusivity protection expiring Nov 2029.

New: ZERBAXA (CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM) — exclusivity NPP*PED exp 11/12/2029

ADDED7/14/2026

Zerbaxa (ceftolozane sulfate; tazobactam sodium) gained nonpriority new chemical entity exclusivity expiring May 2029.

New: ZERBAXA (CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM) — exclusivity NPP exp 05/12/2029