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PRIMAXIN

NDA

CILASTATIN SODIUM; IMIPENEM | N050587 | MERCK AND CO INC

2 strengths0 unique patents0 unique exclusivities

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 Primaxin (2023)

Total Spending

$22K

Total Claims

Beneficiaries

Avg Cost/Unit

$5.28

Spending Trend

$17K(2019)→$45K(2020)→$53K(2021)→$41K(2022)→$22K(2023)

YoY Change:+46.7%

5yr CAGR:+19.0%

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

Approval Letters

13 letters from Drugs@FDA

Date	Submission	Document
Jan 31, 2022	SUPPL -83	View Letter (PDF)
Dec 21, 2018	SUPPL -81	View Letter (PDF)
Dec 21, 2016	SUPPL -74	View Letter (PDF)
Dec 17, 2014	SUPPL -76	View Letter (PDF)
Apr 18, 2012	SUPPL -73	View Letter (PDF)
Nov 20, 2009	SUPPL -72	View Letter (PDF)
Dec 19, 2008	SUPPL -70	View Letter (PDF)
Apr 2, 2008	SUPPL -65	View Letter (PDF)
Aug 7, 2006	SUPPL -64	View Letter (PDF)
May 26, 2004	SUPPL -61	View Letter (PDF)
Mar 10, 2003	SUPPL -58	View Letter (PDF)
Nov 30, 2001	SUPPL -53	View Letter (PDF)
Apr 8, 1998	SUPPL -48	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 250MG BASE/VIAL;250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

POWDER;INTRAVENOUS | Approved: Nov 26, 1985

No patent or exclusivity listings for this strength.

#002 — EQ 500MG BASE/VIAL;500MG/VIAL

RLDAP

0 patents0 exclusivities▾

POWDER;INTRAVENOUS | Approved: Nov 26, 1985