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FLOXIN

NDA

OFLOXACIN | N019735 | JANSSEN PHARMACEUTICALS INC

3 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

2 trials from ClinicalTrials.gov — 1 recruiting, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Evaluation of Antibiotic Prophylaxis in Myelodysplastic Syndromes and Acute Myeloid Leukemia (MYELO-CAN:ABX)NCT07528417	Phase 2	Not Yet Recruiting	University of Manitoba	75	2026-09-01 → 2028-04-30
Serum and Bronchoalveolar Inflammatory Parameters in Patients With Severe Adult Respiratory Distress Syndrome NCT03641690	—	Completed	Centre Hospitalier Universitaire, Amiens	97	2013-09-01 → 2017-12-01

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

Medicare Part D Spending

CMS annual spending data for Ofloxacin* (2023)

Total Spending

$32.3M

Total Claims

1,359,598

Beneficiaries

1,021,068

Avg Cost/Unit

$3.59

Spending Trend

$31.6M(2019)→$25.8M(2020)→$28.1M(2021)→$32.2M(2022)→$32.3M(2023)

YoY Change:-2.7%

5yr CAGR:-0.6%

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

API Supply Chain5 active DMFs5 inactive

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

QUIMICA SINTETICA SAOFLOXACIN

DMF 147672000

CAMBREX CHARLES CITY INCOFLOXACIN USP

DMF 149282000

NEULAND LABORATORIES LTDOFLOXACIN USP

DMF 154332001

MAHIMA LIFE SCIENCES PRIVATE LTDOFLOXACIN USP

DMF 278872013

TURTLE PHARMA PRIVATE LTDOFLOXACIN USP

DMF 332502018

DAIICHI SANKYO PROPHARMA CO LTDInactiveOFLOXACIN BULK PRODUCT

DMF 63511986

NORAMCO INCInactiveOFLOXACIN

DMF 109221994

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveOFLOXACIN USP

DMF 142401999

CIPLA LTDInactiveOFLOXACIN USP

DMF 167532003

KUNSHAN DOUBLE CRANE PHARMACEUTICAL CO LTDInactiveOFLOXACIN

DMF 173082004

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

Approval Letters

11 letters from Drugs@FDA

Date	Submission	Document
Mar 3, 2011	SUPPL -61	View Letter (PDF)
Feb 13, 2009	SUPPL -60	View Letter (PDF)
Oct 7, 2008	SUPPL -59	View Letter (PDF)
Jan 9, 2008	SUPPL -58	View Letter (PDF)
Jul 5, 2007	SUPPL -57	View Letter (PDF)
May 29, 2007	SUPPL -56	View Letter (PDF)
Jun 20, 2006	SUPPL -55	View Letter (PDF)
Jan 30, 2006	SUPPL -54	View Letter (PDF)
Sep 17, 2004	SUPPL -52	View Letter (PDF)
Sep 17, 2004	SUPPL -53	View Letter (PDF)
Mar 10, 2004	SUPPL -51	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Dec 28, 1990

No patent or exclusivity listings for this strength.

#002 — 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Dec 28, 1990

#003 — 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Dec 28, 1990