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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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Altaire Pharmaceuticals, Inc. - Citizen Petition FDA-2013-P-0670 · 3 docket documents Altaire Pharmaceuticals, Inc. filed this citizen petition on June 4, 2013, under Section 505(j) of the Federal Food, Drug and Cosmetic Act requesting that the FDA amend the Orange Book to designate Gentak® Gentamicin Sulfate Ophthalmic Solution, EQ 0.3% base, ANDA 064163 held by Akorn Inc. as a refe	505(q)	2013-06-18	Granted	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

74 trials from ClinicalTrials.gov — 2 recruiting, 48 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Gentamicin for Junctional Epidermolysis Bullosa NCT03526159	Phase 1/2	Recruiting	University of Southern California	6	2018-06-01 → 2020-08-31
Antibiotic Irrigations for Intra-Abdominal Drains NCT03476941	Phase 2	Recruiting	Paolo Goffredo	50	2019-04-01 → 2021-09-01
Effectiveness of Polymyxin B Sulphate + Prednisolone + Benzocaine + Clioquinol in Acute and Sub-acute Dermatitis Eczematous NCT01429701	Phase 3	Completed	EMS	76	2012-05 → 2012-08
Swiss PACK-CXL Multicenter Trial for the Treatment of Infectious Keratitis NCT02717871	Phase 3	Completed	University Hospital, Geneva	35	2016-03 → 2020-10
Effect of Lactobacillus Reuteri DSM17938 in Neonates Treated With Antibiotics NCT02865564	N/A	Completed	University Medical Centre Ljubljana	98	2016-11 → 2020-03
Simplified Antibiotic Therapy for Sepsis in Young Infants NCT01027429	Phase 3	Completed	Aga Khan University	2,543	2009-12 → 2013-12
Infant Severe Sepsis and Bacterial Meningitis in Malawi NCT01247909	Phase 4	Completed	Kamuzu University of Health Sciences	351	2010-04 → 2015-04
Impact of 30 mg/kg Amikacin and 8 mg/kg Gentamicin on Serum Concentrations in Critically Ill Patients With Severe Sepsis NCT02898961	Phase 4	Completed	Centre Hospitalier Universitaire de Nīmes	63	2014-10 → 2016-12-31
Antibiotic "Dysbiosis" in Preterm Infants NCT02784821	Phase 2	Completed	University of Florida	98	2017-01-16 → 2019-09-11
A Randomized Trial of Preoperative Prophylactic Antibiotics Prior to Kidney Stone Surgery (Percutaneous Nephrolithotomy [PCNL])NCT02384200	Phase 4	Completed	University of California, San Diego	86	2015-03 → 2019-06-01

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

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.