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UNASYN

NDA

AMPICILLIN SODIUM; SULBACTAM SODIUM | N050608 | PFIZER INC

4 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 Unasyn (2023)

Total Spending

$93K

Total Claims

507

Beneficiaries

131

Avg Cost/Unit

$2.47

Spending Trend

$212K(2019)→$116K(2020)→$139K(2021)→$91K(2022)→$93K(2023)

YoY Change:+0.8%

5yr CAGR:+4.6%

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

Approval Letters

11 letters from Drugs@FDA

Date	Submission	Document
Nov 6, 2025	SUPPL -58	View Letter (PDF)
Feb 6, 2025	SUPPL -56	View Letter (PDF)
May 2, 2024	SUPPL -53	View Letter (PDF)
Oct 14, 2020	SUPPL -47	View Letter (PDF)
Apr 23, 2018	SUPPL -46	View Letter (PDF)
Feb 14, 2017	SUPPL -44	View Letter (PDF)
Nov 19, 2014	SUPPL -42	View Letter (PDF)
Nov 19, 2014	SUPPL -41	View Letter (PDF)
Mar 13, 2012	SUPPL -40	View Letter (PDF)
Apr 16, 2008	SUPPL -29	View Letter (PDF)
Aug 25, 2004	SUPPL -26	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL

RLDAP

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Dec 31, 1986

No patent or exclusivity listings for this strength.

#002 — EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL

RLDAP

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Dec 31, 1986

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

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Dec 31, 1986

#005 — EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL

RLDAP

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Dec 10, 1993