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LEVAQUIN

NDA

LEVOFLOXACIN | N021721 | JANSSEN PHARMACEUTICALS INC

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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

197 trials from ClinicalTrials.gov — 2 recruiting, 2 active, 135 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Efficacy and Tolerability of Bedaquiline, Delamanid, Levofloxacin, Linezolid, and Clofazimine to Treat MDR-TB NCT03828201	Phase 2	Active	Boston University	271	2022-06-07 → 2027-05
Optimizing the Antibiotic Treatment of Uncomplicated Acute Appendicitis NCT03236961	N/A	Active	Turku University Hospital	552	2017-04-03 → 2029-04-01
Antibiotics vs. Placebo in Acute Uncomplicated Appendicitis NCT03234296	N/A	By Invitation	Turku University Hospital	147	2017-08-09 → 2029-08-30
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia NCT02735707	Phase 3	Recruiting	UMC Utrecht	20,000	2016-04-11 → 2028-02
Study of the Safety and Efficacy of Cefdinir and Levofloxacin for the Treatment of Subjects With Acute Bacterial Sinusitis NCT00645073	Phase 4	Completed	Abbott	271	2003-11
Study of Antibiotic Prophylaxis for Endophthalmitis Following Cataract Surgery NCT00136344	N/A	Completed	City, University of London	35,000	2003-09 → 2006-05
Comparison of the Levofloxacin Sequential Therapy and Quadruple Therapy in Second Line Treatment for HP NCT03148366	Phase 3	Completed	National Taiwan University Hospital	560	2015-02 → 2020-12
Avelox for Treatment of Elderly Patients With Community Acquired Pneumonia NCT00665327	Phase 4	Completed	Bayer	401	2002-11 → 2004-04
Ceftidoren Versus Levofloxacin in the Treatment of Patients With Acute Exacerbations of Chronic Bronchitis (AECB)NCT01467297	Phase 4	Completed	University of Milan	40	2012-01 → 2012-06
Ciprofloxacin Versus Levofloxacin in Stem Cell Transplant NCT03850379	Phase 2	Completed	Henry Ford Health System	308	2018-03-14 → 2024-08-30

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

API Supply Chain23 active DMFs10 inactive

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

CIPLA LTDLEVOFLOXACIN HEMIHYDRATE USP

DMF 158642002

TEVA PHARMACEUTICAL INDUSTRIES LTDLEVOFLOXACIN

DMF 165212003

DR REDDYS LABORATORIES LTDLEVOFLOXACIN HEMIHYDRATE USP

DMF 166582003

CIPLA LTDLEVOFLOXACIN USP

DMF 169222003

MATRIX PHARMACORP PRIVATE LTDLEVOFLOXACIN USP (HEMIHYDRATE)

DMF 175322004

ITF CHEMICAL LTDALEVOFLOXACIN HEMIHYDRATE

DMF 175802004

ZYDUS LIFESCIENCES LTDLEVOFLOXACIN USP (HEMIHYDRATE)

DMF 181182005

HOLIDAY LABS MEXICO SA DE CVLEVOFLOXACIN HEMIHYDRATE

DMF 181592005

NEULAND LABORATORIES LTDLEVOFLOXACIN USP (HEMIHYDRATE)

DMF 188922005

APOTEX PHARMACHEM INDIA PVT LTDLEVOFLOXACIN USP

DMF 194582006

ZHEJIANG APELOA KANGYU PHARMACEUTICAL CO LTDLEVOFLOXACIN HEMIHYDRATE, USP

DMF 195112006

APITORIA PHARMA PRIVATE LTDLEVOFLOXACIN USP (NON-STERILE DRUG SUBSTANCE)

DMF 222652008

MACLEODS PHARMACEUTICALS LTDLEVOFLOXACIN HEMIHYDRATE

DMF 223752008

PH HEALTH LTDLEVOFLOXACIN HEMIHYDRATE (NON-STERILE BULK DRUG SUBSTANCE)

DMF 233822009

ORBION PHARMACEUTICALS PRIVATE LTDLEVOFLOXACIN (NON-STRILE BULK API)

DMF 236392010

HETERO DRUGS LTDLEVOFLOXACIN HEMIHYDRATE, USP

DMF 238652010

HEC PHARM CO LTDLEVOFLOXACIN NON-STERILE BULK DRUG SUBSTANCE

DMF 262952012

ZHEJIANG LANGHUA PHARMACEUTICAL CO LTDLEVOFLOXACIN

DMF 267122012

QUIMICA SINTETICA SALEVOFLOXACIN

DMF 289202014

ZHEJIANG MEDICINE CO LTDLEVOFLOXACIN

DMF 319982017

MSN LIFE SCIENCES PRIVATE LTDLEVOFLOXACIN HEMIHYDRATE USP

DMF 326632018

TURTLE PHARMA PRIVATE LTDLEVOFLOXACIN HEMIHYDRATE USP

DMF 332442018

CHROMO LABORATORIES INDIA PRIVATE LTDLEVOFLOXACIN HEMIHYDRATE USP

DMF 384492024

DAIICHI SANKYO CO LTDInactiveLEVOFLOXACIN DRUG SUBSTANCE

DMF 101021993

QUIMICA SINTETICA SAInactiveLEVOFLOXACIN

DMF 156722001

YUHAN CHEMICAL INCInactiveLEVOFLOXACIN HEMIHYDRATE

DMF 166162003

NEULAND LABORATORIES LTDInactiveLEVOFLOXACIN

DMF 167912003

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveLEVOFLOXACIN USP

DMF 169082003

QUIMICA SINTETICA SAInactiveLEVOFLOXACIN

DMF 194872006

ZHEJIANG JINGXIN PHARMACEUTICAL CO LTDInactiveLEVOFLOXACIN HEMIHYDRATE

DMF 202252007

LUPIN LTDInactiveLEVOFLOXACIN HEMIHYDRATE USP

DMF 229902009

ZHEJIANG MEDICINE CO LTD XINCHANG PHARMACEUTICAL FACTORYInactiveLEVOFLOXACIN DS

DMF 246602011

SHAOXING JINGXIN PHARMACEUTICALS CO LTDInactiveLEVOFLOXACIN HEMIHYDATE

DMF 392122023

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

Approval Letters

27 letters from Drugs@FDA

Date	Submission	Document
Feb 9, 2017	SUPPL -35	View Letter (PDF)
Jul 26, 2016	SUPPL -34	View Letter (PDF)
May 28, 2014	SUPPL -33	View Letter (PDF)
Aug 16, 2013	SUPPL -32	View Letter (PDF)
May 1, 2012	SUPPL -28	View Letter (PDF)
Oct 13, 2011	SUPPL -31	View Letter (PDF)
Oct 13, 2011	SUPPL -29	View Letter (PDF)
Jun 14, 2011	SUPPL -26	View Letter (PDF)
Mar 3, 2011	SUPPL -25	View Letter (PDF)
May 5, 2009	SUPPL -21	View Letter (PDF)
Mar 13, 2009	SUPPL -22	View Letter (PDF)
Oct 7, 2008	SUPPL -20	View Letter (PDF)
May 8, 2008	SUPPL -15	View Letter (PDF)
Apr 18, 2008	SUPPL -19	View Letter (PDF)
Jan 9, 2008	SUPPL -18	View Letter (PDF)
Nov 19, 2007	SUPPL -17	View Letter (PDF)
Nov 19, 2007	SUPPL -16	View Letter (PDF)
Sep 25, 2007	SUPPL -9	View Letter (PDF)
Sep 25, 2007	SUPPL -11	View Letter (PDF)
Jul 5, 2007	SUPPL -13	View Letter (PDF)
Jun 4, 2007	SUPPL -10	View Letter (PDF)
May 16, 2007	SUPPL -12	View Letter (PDF)
Jun 28, 2006	SUPPL -7	View Letter (PDF)
Jan 30, 2006	SUPPL -6	View Letter (PDF)
Aug 8, 2005	SUPPL -2	View Letter (PDF)
Dec 2, 2004	SUPPL -3	View Letter (PDF)
Oct 29, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 250MG/10ML

RLD

0 patents0 exclusivities▴

SOLUTION;ORAL | Approved: Oct 21, 2004

No patent or exclusivity listings for this strength.