Viewing data from:

BICILLIN L-A

NDA

PENICILLIN G BENZATHINE | N050141 | KING PHARMACEUTICALS LLC

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 B Spending

CMS physician-administered drug spending for Bicillin L-A (2023)

Total Spending

$2.5M

Total Claims

7,621

Beneficiaries

5,040

ASP Price

—

HCPCS: J0561 — Injection, penicillin g benzathine, 100,000 units

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

API Supply Chain3 active DMFs4 inactive

3 active API suppliers hold Drug Master Files for this ingredient.

SANDOZ GMBHPENICILLIN G BENZATHINE (STERILE)

DMF 132941998

FRESENIUS KABI IPSUM SRLPENICILLIN G BENZATHINE LECITHIN COATED STERILE

DMF 402972025

APITORIA PHARMA PRIVATE LTDPENICILLIN G BENZATHINE (LECITHIN COATED) STERILE

DMF 406772025

PFIZER INCInactivePENICILLIN G BENZATHINE

DMF 133181998

WYETH-AYERST LABORATORIESInactivePENICILLIN G BENZATHINE

DMF 133281998

BRISTOL EUROPE SPAInactivePENICILLIN G BENZATHINE

DMF 136551998

GIST-BROCADES NV PHARMACEUTICALSInactivePENICILLIN G BENZATHINE

DMF 137321998

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

16 letters from Drugs@FDA

Date	Submission	Document
Jun 29, 2026	SUPPL -242	View Letter (PDF)
Jun 29, 2026	SUPPL -243	View Letter (PDF)
May 17, 2021	SUPPL -240	View Letter (PDF)
Dec 14, 2020	SUPPL -238	View Letter (PDF)
Dec 9, 2020	SUPPL -239	View Letter (PDF)
Apr 30, 2019	SUPPL -237	View Letter (PDF)
Nov 15, 2018	SUPPL -236	View Letter (PDF)
Dec 12, 2017	SUPPL -235	View Letter (PDF)
Oct 14, 2015	SUPPL -233	View Letter (PDF)
Apr 29, 2014	SUPPL -232	View Letter (PDF)
Sep 7, 2012	SUPPL -231	View Letter (PDF)
Dec 31, 2009	SUPPL -226	View Letter (PDF)
Nov 18, 2005	SUPPL -224	View Letter (PDF)
Apr 29, 2002	SUPPL -218	View Letter (PDF)
Apr 29, 2002	SUPPL -219	View Letter (PDF)
Mar 1, 2002	SUPPL -215	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 600,000 UNITS/ML

RLDBC

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#003 — 300,000 UNITS/ML

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982