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BICILLIN

NDA

PENICILLIN G BENZATHINE | N050126 | WYETH AYERST LABORATORIES

1 strength0 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

1 trial from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Non-Inferiority Trial of Stopping Penicillin in Early Rheumatic Heart Disease: GOAL-Stop NCT07146048	Phase 3	Recruiting	Children's Hospital Medical Center, Cincinnati	922	2026-03-23 → 2029-12-31

Source: ClinicalTrials.gov. Trials matched by ingredient name.

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.

Products (1)

#002 — 300,000 UNITS/5ML

0 patents0 exclusivities▴

SUSPENSION;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.