Viewing data from:

KEFLET

NDA

CEPHALEXIN | N050440 | ELI LILLY AND CO

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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Lachman Consultant Services, Inc. - Citizen Petition FDA-2009-P-0256 · 8 docket documents Lachman Consultant Services, Inc. filed this petition on behalf of a client requesting that the FDA determine whether Keflex (cephalexin) Capsules, 333 mg (NDA 50-405) held by Lex Pharms was voluntarily withdrawn or withheld from sale for reasons of safety or efficacy under 21 CFR 314.162, as this d	505(q)	2009-06-04	Denied	—

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

Clinical Trials

42 trials from ClinicalTrials.gov — 3 recruiting, 29 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Antibiotic Prophylaxis in High-Risk Arthroplasty Patients NCT04297592	Phase 4	By Invitation	Mayo Clinic	4,618	2020-06-11 → 2026-06
Antibiotic Prophylaxis in Rhinoplasty NCT04194216	Phase 3	By Invitation	Stanford University	864	2020-05-20 → 2027-04-20
Effects of Treatments on Atopic Dermatitis NCT01631617	Phase 2	Recruiting	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	130	2012-09-18 → 2027-01-01
Cross-over Study to Prove Bioequivalence Between Two Brands of Cefalexin Suspension NCT01073540	Phase 1	Completed	Bayer	26	2009-09 → 2009-09
Comparing Healthcare Utilization Between Adenotonsillectomy Patients With and Without Postoperative Antibiotic Use NCT01561703	N/A	Completed	University of Missouri-Columbia	58	2012-03 → 2015-06
A Study of Cephalexin Liquid in Healthy Participants NCT02490670	Phase 1	Completed	Eli Lilly and Company	28	2015-07 → 2015-07
Prophylactic Antibiotics After Cesarean NCT03187106	Phase 1	Completed	The University of Texas Medical Branch, Galveston	321	2017-08-01 → 2023-07-21
Perioperative Antibiotic Therapy to Prevent Cardiac Implantable Electronic Device Infections.NCT02809131	Phase 3	Completed	Vanderbilt University Medical Center	1,010	2016-04-01 → 2021-09-30
Comparison of Cephalexin Versus Clindamycin for Suspected CA-MRSA Skin Infections NCT00352612	Phase 4	Completed	Aaron Chen	200	2006-09 → 2009-08
Study of New Antibiotic Regimen for the Treatment of Uncomplicated Cellulitis in Emergency Department Patients NCT00676130	N/A	Completed	Brigham and Women's Hospital	153	2007-05 → 2012-05

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

API Supply Chain8 active DMFs21 inactive

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

CENTRIENT PHARMACEUTICALS NETHERLANDS BVCEPHALEXIN MONOHYDRATE

DMF 132101998

ANTIBIOTICOS SACEPHALEXIN MONOHYDRATE

DMF 135881998

ACS DOBFAR SPACEPHALEXIN MONOHYDRATE

DMF 136121998

ORCHID PHARMA LTDCEPHALEXIN USP

DMF 151062000

LUPIN LTDCEPHALEXIN USP

DMF 172772004

APITORIA PHARMA PRIVATE LTDCEPHALEXIN USP

DMF 176042004

APITORIA PHARMA PRIVATE LTDCEPHALEXIN USP (ENZYMATIC ROUTE)

DMF 329302019

LUPIN LTDCEPHALEXIN USP (ENZYMATIC)

DMF 413572025

GLAXO LABORATORIES SAInactiveCEPHALEXIN

DMF 18201971

ELANCO QUIMICA LIMITADAInactiveCEPHALEXIN DISOLVATE

DMF 98891992

LILLY RESEARCH LABORATORIESInactiveCEPHALEXIN MONOHYDRATE

DMF 133851998

LARKInactiveCEPHALEXIN MONOHYDRATE

DMF 135191998

ISFInactiveCEPHALEXIN MONOHYDRATE

DMF 135341998

ANTIBIOTICOSInactiveCEPHALEXIN MONOHYDRATE

DMF 135641998

DISTA PRODUCTS CO DIV ELI LILLY AND COInactiveCEPHALEXIN

DMF 136101998

YOSHITOMI PHARMACEUTICAL INDUSTRIES LTDInactiveCEPHALEXIN

DMF 137151998

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveCEPHALEXIN

DMF 137191998

SQUIBB GInactiveCEPHALEXIN

DMF 137201998

BRISTOL MYERS SQUIBB COInactiveCEPHALEXIN

DMF 137231998

BENZEX LABORATORIES LTDInactiveCEPHALEXIN

DMF 137331998

BIOCHEMIE SAInactiveCEPHALEXIN

DMF 137471998

LUPIN LTDInactiveCEPHALEXIN

DMF 137521998

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveCEPHALEXIN USP

DMF 137591998

TAIWAN BIOTECH CO LTDInactiveCEPHALEXIN

DMF 137811998

JK DRUGS AND PHARMACEUTICALS LTDInactiveCEPHALEXIN USP

DMF 142661999

LILLY RESEARCH LABORATORIES DIV ELI LILLY AND COInactiveCEPHALEXIN MONOHYDRATE BULK

DMF 149202000

UNIMARK REMEDIES LTDInactiveCEPHALEXIN USP

DMF 183612005

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveCEPHALEXIN USP (COMPACTED)

DMF 191622006

YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTDInactiveCEPHALEXIN USP "YUNG SHIN"

DMF 238722010

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

Products (3)

Sort:

#001 — EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.

#002 — EQ 1GM BASE

0 patents0 exclusivities▾

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

#003 — EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Feb 26, 1987