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CLOLAR

NDA

CLOFARABINE | N021673 | GENZYME CORP

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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
GENZYME CORPORATION et al v. HERITAGE PHARMA LABS, INC. et al 1:2014cv05975 1 patentANDA 206972clofarabine	D.N.J.	2014-09-24	Terminated 2015-08-11	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov, 1 active

Trial	Phase	Status	Sponsor	Enrollment	Dates
Study of Clofarabine in Patients With Recurrent or Refractory Langerhans Cell Histiocytosis and LCH-related Disorders NCT02425904	Phase 2	Active	Dana-Farber Cancer Institute	25	2015-05 → 2026-12-31

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

API Supply Chain10 active DMFs2 inactive

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

MATRIX PHARMACORP PRIVATE LTDCLOFARABINE

DMF 256332012

OLON SPACLOFARABINE

DMF 266352012

SCINOPHARM TAIWAN LTDCLOFARABINE

DMF 275662014

EMCURE PHARMACEUTICALS LTDCLOFARABINE

DMF 277972013

MSN LABORATORIES PRIVATE LTDCLOFARABINE [ROUTE CODE "CF"]

DMF 278622014

BIOPHORE INDIA PHARMACEUTICALS PVT LTDCLOFARABINE

DMF 279012014

SUN PHARMACEUTICAL INDUSTRIES LTDCLOFARABINE

DMF 293182015

GUANGZHOU HENOVCOM BIOSCIENCE CO LTDCLOFARABINE

DMF 297062015

SHILPA PHARMA LIFESCIENCES LTDCLOFARABINE

DMF 298062015

ALEMBIC PHARMACEUTICALS LTDCLOFARABINE

DMF 350332020

SYNBIAS PHARMA AGInactiveCLOFARABINE

DMF 293722015

QILU PHARMACEUTICAL CO LTDInactiveCLOFARABINE

DMF 297692015

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

Approval Letters

10 letters from Drugs@FDA

Date	Submission	Document
Jul 19, 2022	SUPPL -27	View Letter (PDF)
Dec 26, 2019	SUPPL -26	View Letter (PDF)
Oct 31, 2016	SUPPL -25	View Letter (PDF)
Dec 18, 2015	SUPPL -24	View Letter (PDF)
Sep 17, 2014	SUPPL -23	View Letter (PDF)
Jan 14, 2013	SUPPL -22	View Letter (PDF)
Jun 15, 2011	SUPPL -10	View Letter (PDF)
Oct 23, 2008	SUPPL -7	View Letter (PDF)
Oct 23, 2008	SUPPL -5	View Letter (PDF)
Dec 29, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 20MG/20ML (1MG/ML)

RLD

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Dec 28, 2004

No patent or exclusivity listings for this strength.