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NDA

NEOMYCIN SULFATE | N050285 | PHARMACIA AND UPJOHN CO

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

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Fermenta Animal Health FDA-1992-P-0497 · 7 docket documents Fermenta Animal Health Company submitted a suitability petition under Section 512(n)(3) of the Federal Food, Drug and Cosmetic Act requesting permission to file an abbreviated new animal drug application (ANADA) for NEOVET (Neomycin Sulfate) Bolus, an oral solid dosage form for cattle, swine, sheep	Other	2017-04-03	Granted	Fermenta Animal Health
Citizen Petition from Sparhawk Laboratories, Inc FDA-2006-P-0332 · 4 docket documents Sparhawk Laboratories, Inc. filed this petition on June 19, 2006, to change the dosage form of Neomycin from soluble powder to liquid under NADA 11-315, with supporting data submitted as Neomycin Liquid under ANADA 200-379, and requested categorical exclusion from environmental assessment requiremen	Other	2009-03-30	Granted	Sparhawk Laboratories, Inc

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

Clinical Trials

26 trials from ClinicalTrials.gov, 2 active, 14 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Comparing No Mechanical Bowel Preparation With Oral Antibiotics Alone in Patients Undergoing Elective Colon Surgery NCT03663504	Phase 4	Active	Ottawa Hospital Research Institute	630	2018-10-23 → 2026-10
CARNIVAL Study: Gut Flora Dependent Metabolism of Dietary CARNItine and Phosphatidylcholine and cardioVAscuLar Disease NCT01731236	Early Phase 1	Active	The Cleveland Clinic	100	2011-02-11 → 2029-12
Responses to Rabies Vaccine in Adults With or Without Antibiotics NCT03557008	Phase 4	Completed	Emory University	37	2018-07-05 → 2022-06-02
Use of Probiotics to Prevent Cholangitis in Children With Biliary Atresia After the Kasai Portoenterostomy NCT00166868	N/A	Completed	National Taiwan University Hospital	30	2003-12 → 2012-07
Effect of Neomycin on the Pharmacokinetics of Regorafenib NCT02001909	Phase 1	Completed	Bayer	27	2013-12 → 2014-04
Prophylatic Effect Preoperative Antibiotics With Mechanical Bowel Preparation in SSIs NCT03856671	N/A	Completed	Third Affiliated Hospital, Sun Yat-Sen University	309	2019-01-17 → 2023-03-31
Systems Biology of Flu Vaccine in Healthy Adults With and Without the Use of Antibiotics NCT02154061	N/A	Completed	Emory University	33	2015-04 → 2017-05-26
Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease NCT02765256	Phase 2	Completed	University of Pennsylvania	8	2016-08 → 2018-12
Open Study of the Efficacy of the Local Treatment With Polygynax of Bacterial and/or Mycotic Vaginitis NCT02444481	Phase 4	Completed	Laboratoire Innotech International	169	2009-04 → 2009-11
Neomycin and Rifaximin Plus Neomycin in Treating Methane Positive Constipation Predominant Irritable Bowel Syndrome NCT00945334	N/A	Completed	Mark Pimentel, MD	37	2009-08 → 2013-06

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

Medicare Part D Spending

CMS annual spending data for Neomycin Sulfate (2024)

Total Spending

$954K

Total Claims

89,388

Beneficiaries

80,548

Avg Cost/Unit

$0.88

Spending Trend

$1.0M(2019)→$955K(2020)→$1.0M(2021)→$712K(2022)→$737K(2023)→$954K(2024)

YoY Change:-10.4%

5yr CAGR:-1.2%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain3 active DMFs10 inactive

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

PHARMACIA AND UPJOHN CO WHOLLY OWNED SUB PFIZER INCNEOMYCIN SULFATE USP

DMF 133781998

HUASHU PHARMACEUTICAL CORPNEOMYCIN SULFATE

DMF 173822004

YICHANG SANXIA PHARMACEUTICAL CO LTDNEOMYCIN SULFATE AND NEOMYCIN SULFATE MICRONIZED

DMF 320912017

SB PENICK AND COInactiveNEOMYCIN SULFATE USP

DMF 1101953

PFIZER INCInactiveNEOMYCIN SULFATE CAPS (THIS D CHANGED TO NDA 9-579)

DMF 1241953

APOTHEKERNES LABORATORIUM ASInactiveNEOMYCIN SULFATE

DMF 2421940

UPJOHN COInactiveNEOMYCIN SULFATE 0.5GM, COMMERICIAL GRADE, NOT USP

DMF 2621940

CHAS PFIZER AND CO INCInactiveNEOMYCIN SULFATE (VET MED)

DMF 2701940

MERCK AND CO INCInactiveNEOMYCIN SULFATE

DMF 2711940

PENICK CORPInactiveNEOMYCIN SULFATE

DMF 132861998

APOTHEKERNES LABORATORIUM ASInactiveNEOMYCIN SULFATE

DMF 135281998

APOTHEKERNES LABORATORIUM ASInactiveNEOMYCIN SULFATE

DMF 136091998

ROUSSELL UCLAFInactiveNEOMYCIN SULFATE

DMF 136151998

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

Products (1)

#001 — EQ 87.5MG BASE/5ML

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.