Viewing data from:

GARAMYCIN

NDA

GENTAMICIN SULFATE | N050039 | SCHERING CORP SUB SCHERING PLOUGH CORP

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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Gentamicin Sulfate* (2023)

Total Spending

$13.1M

Total Claims

390,442

Beneficiaries

255,052

Avg Cost/Unit

$1.62

Spending Trend

$19.3M(2019)→$24.9M(2020)→$13.8M(2021)→$13.5M(2022)→$13.1M(2023)

YoY Change:-7.8%

5yr CAGR:-2.7%

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

API Supply Chain4 active DMFs9 inactive

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

FUJIAN FUKANG PHARMACEUTICAL CO LTDGENTAMICIN SULFATE

DMF 120481996

LEK PHARMACEUTICALS DDGENTAMICIN SULFATE

DMF 137041998

ACS DOBFAR SPAGENTAMICIN SULFATE

DMF 241982010

LIVZON GROUP FUZHOU FUXING PHARMACEUTICAL CO LTDGENTAMICIN SULFATE

DMF 306932016

SCHERING PHARMACEUTICAL CORPInactiveGENTAMICIN SULFATE

DMF 134371998

GIST-BROCADES NV PHARMACEUTICALSInactiveGENTAMICIN SULFATE

DMF 136201998

PHARMACHIM ECONOMIC CORPInactiveGENTAMICIN SULFATE

DMF 136251998

SHANGHAI ASIA PIONEER PHARMACEUTICALS CO LTDInactiveGENTAMICIN SULFATE

DMF 136301998

SICHUAN LONG MARCH PHARMACEUTICAL CO LTDInactiveGENTAMICIN SULFATE

DMF 136371998

MEIJI SEIKA KAISHA LTDInactiveGENTAMICIN SULFATE

DMF 136581998

ANSA ANTIBIOTIK VE ILAC HAMMADDERI SANAYI A SInactiveGENTAMICIN SULFATE

DMF 136711998

YANTAI NO 2 PHARMACEUTICAL FACTORYInactiveGENTAMICIN SULFATE

DMF 148662000

HENAN KAIFENG PHARMACEUTICAL FACTORYInactiveGENTAMICIN SULFATE

DMF 199162006

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

Products (1)

#002 — EQ 0.3% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.