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PENBRITIN-S

NDA

AMPICILLIN SODIUM | N050072 | WYETH AYERST LABORATORIES

6 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 Ampicillin Sodium* (2023)

Total Spending

$4.7M

Total Claims

20,847

Beneficiaries

3,864

Avg Cost/Unit

$3.73

Spending Trend

$3.3M(2019)→$3.7M(2020)→$4.1M(2021)→$4.3M(2022)→$4.7M(2023)

YoY Change:-13.1%

5yr CAGR:+0.3%

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

Medicare Part B Spending

CMS physician-administered drug spending for Ampicillin Sodium (J2543) (2023)

Total Spending

$55K

Total Claims

3,554

Beneficiaries

1,098

ASP Price

$1.28

Spending Trend

$55K(2023)→$9K(2023)

YoY Change:-8.4%

5yr CAGR:-12.1%

HCPCS: J2543 — Injection, piperacillin sodium/tazobactam sodium, 1 gram/0.125 grams (1.125 grams)

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

API Supply Chain18 active DMFs39 inactive

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

SANDOZ INDUSTRIAL PRODUCTS SAAMPICILLIN ANHYDROUS

DMF 132121998

FERSINSA GB SA DE CVAMPICILLIN TRIHYDRATE

DMF 134261998

ANTIBIOTICOS SAAMPICILLIN TRIHYDRATE

DMF 134401998

ACS DOBFAR SPAAMPICILLIN SODIUM (STERILE BULK)

DMF 136611998

ISTITUTO BIOCHIMICO ITALIANO GIOVANNI LORENZINI SPAAMPICILLIN SODIUM STERILE CRYSTALLINE (BULK)

DMF 137421998

SANDOZ GMBHAMPICILLIN SODIUM (STERILE)

DMF 137541998

SANDOZ INDUSTRIAL PRODUCTS SAAMPICILLIN TRIHYDRATE

DMF 137651998

FERSINSA GB SA DE CVAMPICILLIN ANHYDROUS

DMF 137771998

APITORIA PHARMA PRIVATE LTDAMPICILLIN SODIUM USP (STERILE) BULK

DMF 202112007

ZHUHAI UNITED LABORATORIES CO LTDAMPICILLIN TRIHYDRATE

DMF 228572009

FRESENIUS KABI IPSUM SRLAMPICILLIN SODIUM STERILE

DMF 232872009

STERILE INDIA PVT LTDAMPICILLIN SODIUM USP (STERILE)

DMF 299842018

ADL BIOPHARMA SLUAMPICILLIN TRIHYDRATE

DMF 308152016

INNER MONGOLIA CHANGSHENG PHARMACEUTICAL CO LTDAMPICILLIN TRIHYDRATE

DMF 357352021

APITORIA PHARMA PRIVATE LTDAMPICILLIN TRIHYDRATE USP (ENZYME ROUTE)

DMF 379142023

SINOPHARM WEIQIDA PHARMACEUTICAL CO LTDAMPICILLIN TRIHYDRATE (POWDER)

DMF 380562023

INNER MONGOLIA CHANGSHENG PHARMACEUTICAL CO LTDAMPICILLIN ANHYDROUS

DMF 397282024

INNER MONGOLIA CHANGSHENG PHARMACEUTICAL CO LTDAMPICILLIN TRIHYDRATE (COMPACTED)

DMF 412932025

BAYER AGInactiveAMPICILLIN SODIUM STERILE

DMF 81091989

KOPRAN LTDInactiveAMPICILLIN TRIHYDRATE

DMF 88431990

SMITHKLINE BEECHAM PHARMACEUTICALSInactiveAMPICILLIN TRIHYDRATE

DMF 132961998

SMITHKLINE BEECHAM PHARMACEUTICALSInactiveAMPICILLIN

DMF 132971998

GLAXOCHEM LTDInactiveAMPICILLIN TRIHYDRATE

DMF 132991998

FERMENTA PRODUCTS INCInactiveAMPICILLIN

DMF 133291998

PIERREL AMERICA INCInactiveAMPICILLIN TRIHYDRATE

DMF 133641998

WYETH-AYERST LABORATORIESInactiveAMPICILLIN SODIUM

DMF 133791998

COMPANHIA INDUSTRIAL PRODUTORA DE ANTIBIOTICOS SARLInactiveAMPICILLIN TRIHYDRATE

DMF 133821998

BARCELONETA INC DIV BRISTOL MYERSInactiveAMPICILLIN TRIHYDRATE

DMF 134081998

TEVA PHARMACEUTICALS INDUSTRIES LTDInactiveAMPICILLIN TRIHYDRATE

DMF 134231998

PHARMACIA AND UPJOHNInactiveAMPICILLIN SODIUM

DMF 134251998

CORDEN PHARMA LATINA SPAInactiveAMPICILLIN

DMF 134351998

BRISTOL MYERS SQUIBB COInactiveAMPICILLIN TRIHYDRATE

DMF 134381998

GIST-BROCADES NV PHARMACEUTICALSInactiveAMPICILLIN

DMF 134481998

SMITHKLINE BEECHAM PHARMACEUTICALSInactiveAMPICILLIN TRIHYDRATE

DMF 134791998

SMITHKLINE BEECHAM PHARMACEUTICALSInactiveAMPICILLIN SODIUM

DMF 134801998

PFIZER INCInactiveAMPICILLIN TRIHYDRATE

DMF 134931998

SQUIBBInactiveAMPICILLIN TRIHYDRATE

DMF 135141998

ANKERFARM SPAInactiveAMPICILLIN

DMF 135161998

ER SQUIBB AND SONS INCInactiveAMPICILLIN SODIUM

DMF 135321998

CANADA PACKERS INC FINE CHEMICALS DIVInactiveAMPICILLIN TRIHYDRATE

DMF 135401998

GIST-BROCADES NV PHARMACEUTICALSInactiveAMPICILLIN TRIHYDRATE

DMF 135671998

GIST-BROCADES NV PHARMACEUTICALSInactiveAMPICILLIN SODIUM

DMF 135691998

FERMENTACIONES Y SINTESIS SA DE CVInactiveAMPICILLIN TRIHYDRATE

DMF 135971998

PLANTEX USA INCInactiveAMPICILLIN TRIHYDRATE

DMF 136111998

CONSOLIDATED PHARMACEUTICAL GROUP INCInactiveAMPICILLIN TRIHYDRATE

DMF 136231998

BAYER AGInactiveAMPICILLIN TRIHYDRATE

DMF 136271998

CONSOLIDATED PHARMACEUTICAL GROUP INCInactiveAMPICILLIN

DMF 136451998

PRO CHIM RE SPAInactiveAMPICILLIN TRIHYDRATE

DMF 136781998

PRO CHIM RE SPAInactiveAMPICILLIN

DMF 136791998

FERMENTA PRODUCTS INCInactiveAMPICILLIN TRIHYDRATE

DMF 136811998

BAYER AGInactiveAMPICILLIN

DMF 136881998

RANBAXY LABORATORIES LTDInactiveAMPICILLIN TRIHYDRATE

DMF 137121998

BRISTOL MYERSInactiveAMPICILLIN

DMF 137791998

GLAXO PHARMACEUTICALS LTDInactiveAMPICILLIN TRIHYDRATE

DMF 142121980

NORTH CHINA PHARMACEUTICAL GROUP SEMISYNTECH CO LTDInactiveAMPICILLIN TRIHYDRATE

DMF 247132011

CSPC ZHONGNUO PHARMACEUTICAL SHIJIAZHUANG CO LTDInactiveAMPICILLIN TRIHYDRATE

DMF 250352011

CENTRIENT PHARMACEUTICALS NETHERLANDS BVInactiveAMPICILLIN TRIHYDRATE (PURICILLIN)

DMF 265052012

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

Products (6)

Sort:

#001 — EQ 125MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

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