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

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 Recarbrio (2023)

Total Spending

$1.1M

Total Claims

181

Beneficiaries

Avg Cost/Unit

$118.43

Spending Trend

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

YoY Change:+372.4%

5yr CAGR:+165.8%

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

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

1 patent3 exclusivities▴

POWDER;INTRAVENOUS | Approved: Jul 16, 2019

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
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