Viewing data from:

MAVENCLAD

NDA

CLADRIBINE | N022561 | EMD SERONO INC

1 strength3 unique patents0 unique exclusivities

Patent Timeline

3 unique patents by expiration date

Active (3)TodayIPRPTAB Challenge

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Today

10849919

Nov. 23, 2038IPR

12533408

Sep. 10, 2041

12539329

Sep. 10, 2041

PTAB Proceedings

1 challenge on OB patents at the Patent Trial and Appeal Board

Trial #	Patent	Type	Petitioner	Status	Filed	Decision
IPR2023-00482	10849919	IPR	Hopewell Pharma Ventures, Inc. et al.	Terminated-Settled	2023-02-10	2023-08-16

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
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).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Mavenclad (2023)

Total Spending

$156.3M

Total Claims

2,078

Beneficiaries

1,130

Avg Cost/Unit

$10204.59

Spending Trend

$34.8M(2019)→$110.8M(2020)→$144.6M(2021)→$126.8M(2022)→$156.3M(2023)

YoY Change:+7.7%

5yr CAGR:+7.7%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

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

6 letters from Drugs@FDA

Date	Submission	Document
May 18, 2026	SUPPL -13	View Letter (PDF)
May 13, 2024	SUPPL -11	View Letter (PDF)
Feb 15, 2024	SUPPL -9	View Letter (PDF)
Dec 7, 2023	SUPPL -7	View Letter (PDF)
Sep 20, 2022	SUPPL -6	View Letter (PDF)
Apr 4, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10MG

RLDAB

3 patents0 exclusivities▴

TABLET;ORAL | Approved: Mar 29, 2019

Patents (3)

Patent #	Expiration	PED	Drug Substance	Drug Product	Delist
10849919	Nov 23, 2038	—	—	—	—
12533408	Sep 10, 2041	—	—	—	—
12539329	Sep 10, 2041	—	—	—	—