Viewing data from:

LAMPRENE

NDA

CLOFAZIMINE | N019500 | NOVARTIS PHARMACEUTICALS CORP

2 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

1 trial from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Study of Mycobacterial Infections NCT00018044	—	Recruiting	National Institute of Allergy and Infectious Diseases (NIAID)	1,000	2001-01-01

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

API Supply Chain6 active DMFs1 inactive

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

SANDOZ PRIVATE LTDCLOFAZIMINE

DMF 166682003

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDCLOFAZIMINE USP

DMF 312562016

OLON SPACLOFAZIMINE

DMF 331572018

MIDAS PHARMA GMBHCLOFAZIMINE

DMF 342542019

OLON SPACLOFAZIMINE ORTHORHOMBIC

DMF 380352023

HARMAN FINOCHEM LTDCLOFAZIMINE

DMF 399722024

SANGROSE LABORATORIES PVT LTDInactiveCLOFAZIMINE

DMF 253262011

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

Approval Letters

3 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 100MG

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Dec 15, 1986

No patent or exclusivity listings for this strength.

#002 — 50MG

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Dec 15, 1986