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CLADRIBINE

ANDA

CLADRIBINE | A215547 | HOPEWELL PHARMA VENTURES INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: MAVENCLAD(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Merck KGaA et al v. Hopewell Pharma Ventures, Inc., et al. 1:2022cv01365 3 patentsANDA 215547cladribine	D. Del.	2022-10-17	Terminated 2026-01-29	—

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

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.

Products (1)

#001 — 10MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Mar 27, 2026

No patent or exclusivity listings for this strength.