Viewing data from:

RECARBRIO

NDA

CILASTATIN SODIUM; IMIPENEM; RELEBACTAM | N212819 | MERCK SHARP AND DOHME CORP A SUB OF MERCK AND CO INC

1 strength1 unique patent3 unique exclusivities

Patent Timeline

1 unique patent, 3 exclusivities by expiration date

Active (1)TodayExclusivity

2025

2026

2027

2028

2029

2030

2031

2032

2033

Today

8487093

Mar. 21, 2033

NCE

Jul. 16, 2024

NPP

Dec. 9, 2028

GAIN

Jul. 16, 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

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Peter Doshi FDA-2025-P-1575 Peter Doshi filed this citizen petition requesting that the FDA withdraw approval of Recarbrio (imipenem-cilastatin-relebactam) under NDA 212819 and 21 CFR § 314.150, arguing that the pivotal clinical trials submitted by Merck did not meet the legal requirement of substantial evidence from adequate	Other	2025-06-05	Open	Peter Doshi

Source: Regulations.gov. FDA citizen petitions matched by application number.

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

$5640.94

Highest Price

$7228.28

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00006-3856-02RECARBRIO	$5640.94	Big4	Merck Sharp & Dohme LLC	05/31/2030
00006-3856-02RECARBRIO	$7228.28	FSS	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 Recarbrio (2024)

Total Spending

$1.2M

Total Claims

178

Beneficiaries

Avg Cost/Unit

$163.65

Spending Trend

$180K(2020)→$942K(2021)→$1.1M(2022)→$1.1M(2023)→$1.2M(2024)

YoY Change:+38.2%

5yr CAGR:+125.7%

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 Recarbrio (2024)

Total Spending

$2K

Total Claims

331

Beneficiaries

—

ASP Price

$2.48

Spending Trend

$51K(2020)→$36K(2021)→$2K(2024)

5yr CAGR:+14.7%

HCPCS: J0742 — Injection, imipenem 4 mg, cilastatin 4 mg and relebactam 2 mg

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Dec 10, 2025	SUPPL -8	View Letter (PDF)
Jun 8, 2020	SUPPL -2	View Letter (PDF)
Jul 31, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL

RLD

3 patents3 exclusivities▴

POWDER;INTRAVENOUS | Approved: Jul 16, 2019

Patents (3)

Patent #	Expiration	PED	Drug Substance	Drug Product	Delist
8487093	Mar 21, 2033	—	Yes	Yes	—
8487093	Mar 21, 2033	—	Yes	Yes	—
8487093	Mar 21, 2033	—	Yes	Yes	—

Exclusivities (3)

Code	Date	Status
GAIN	Jul 16, 2029	Active
NCE	Jul 16, 2024	Expired
NPP	Dec 9, 2028	Active