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LEUSTATIN

NDA

CLADRIBINE | N020229 | 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

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
Efficacy and Safety of a New Formulation of Oral Cladribine Compared With Placebo in Participants With Generalized Myasthenia Gravis (MyClad)NCT06463587	Phase 3	Recruiting	Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany	264	2024-06-25 → 2030-11-12

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

API Supply Chain10 active DMFs3 inactive

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

RELIABLE BIOPHARMACEUTICAL LLCCLADRIBINE

DMF 130061998

ZHEJIANG HISUN PHARMACEUTICAL CO LTDCLADRIBINE USP

DMF 162052002

CILAG AGCLADRIBINE DRUG SUBSTANCE

DMF 176032004

SCINOPHARM TAIWAN LTDCLADRIBINE USP

DMF 245102010

GUANGZHOU HENOVCOM BIOSCIENCE CO LTDCLADRIBINE DRUG SUBSTANCE

DMF 315052017

MSN LABORATORIES PRIVATE LTDCLADRIBINE USP

DMF 358062021

BIOPHORE INDIA PHARMACEUTICALS PVT LTDCLADRIBINE HPßCD COMPLEX

DMF 362212021

BIOPHORE INDIA PHARMACEUTICALS PVT LTDCLADRIBINE

DMF 362222021

MSN LABORATORIES PRIVATE LTDCLADRIBINE CYCLODEXTRIN

DMF 363202021

HUBEI BIOCAUSE HEILEN PHARMACEUTICAL CO LTDCLADRIBINE DRUG SUBSTANCE

DMF 399252024

CILAG AGInactiveCLADRIBINE

DMF 122311996

AXITEC CO LTDInactiveCLADRIBINE

DMF 180722005

CHANGZHOU AHK TECH INCInactiveCLADRIBINE NON-STERILE BULK DRUG

DMF 232282009

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Aug 3, 2012	SUPPL -34	View Letter (PDF)
Jul 3, 2006	SUPPL -30	View Letter (PDF)
Aug 22, 2002	SUPPL -21	View Letter (PDF)
Aug 20, 2002	SUPPL -4	View Letter (PDF)
Aug 20, 2002	SUPPL -7	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Feb 26, 1993

No patent or exclusivity listings for this strength.