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Last Updated: October 31, 2024

MAVENCLAD Drug Patent Profile


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Which patents cover Mavenclad, and what generic alternatives are available?

Mavenclad is a drug marketed by Emd Serono Inc and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and fifty-three patent family members in thirty-five countries.

The generic ingredient in MAVENCLAD is cladribine. There are eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the cladribine profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Mavenclad

A generic version of MAVENCLAD was approved as cladribine by HIKMA on February 28th, 2000.

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Drug patent expirations by year for MAVENCLAD
Drug Prices for MAVENCLAD

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Recent Clinical Trials for MAVENCLAD

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
The Leeds Teaching Hospitals NHS TrustPhase 2/Phase 3
Queen Mary University of LondonPhase 2/Phase 3
University of EdinburghPhase 2/Phase 3

See all MAVENCLAD clinical trials

Pharmacology for MAVENCLAD
Paragraph IV (Patent) Challenges for MAVENCLAD
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
MAVENCLAD Tablets cladribine 10 mg 022561 1 2022-04-07

US Patents and Regulatory Information for MAVENCLAD

MAVENCLAD is protected by five US patents.

Patents protecting MAVENCLAD

Cladribine regimen for treating progressive forms of multiple sclerosis
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATING NON-EARLY SPMS BY ADMINISTERING ORAL CLADRIBINE AT A FIXED DOSE PER PATIENT, PER BODY WEIGHT AND PER TREATMENT YEAR, WHICH FIXED DOSE IS 1.75 +/- 0.2 MG/KG, TO BE ADMINISTERED WITHIN MONTHS 1 AND 2 IN EACH OF 2 ADJACENT TREATMENT YEARS

Cladribine regimen for treating multiple sclerosis
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Patented Use: TREATING MS WITH ORAL CLADRIBINE ACC. TO THE STEPS (I) INDUCTION PERIOD WITH ABOUT 1.7 MG/KG-3.5 MG/KG CLADRIBINE; (II) CLADRIBINE-FREE PERIOD OF ABOUT 8-10 MONTHS; (III) MAINTENANCE PERIOD WITH ABOUT 1.7 MG/KG CLADRIBINE; (IV) CLADRIBINE-FREE PERIOD

Oral formulations of cladribine
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Patented Use: TREATMENT OF MS WITH A TABLET WITH AN ADMIXTURE OF (A) AN AMORPHOUS INCLUSION COMPLEX OF CLADRIBINE AND HYDROXYPROPYL-B-CYCLODEXTRIN AND (B) AMORPHOUS FREE CLADRIBINE AND CYCLODEXTRIN AS A NON-INCLUSION COMPLEX, CLADRIBINE/CYCLODEXTRIN 1:10-1:16 W/W

Cladribine regimen for treating multiple sclerosis
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Patented Use: TREATING RRMS OR SPMS WITH ORAL CLADRIBINE: (I) 2-4 MONTHS INDUCTION WITH 1.7 MG/KG - 3.5 MG/KG CLADRIBINE; (II) CLADRIBINE-FREE PERIOD OF ABOUT 8-10 MONTHS; (III) 2-4 MONTHS MAINTENANCE WITH ABOUT 1.7 MG/KG CLADRIBINE; (IV) CLADRIBINE-FREE PERIOD

Oral formulations of cladribine
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Patented Use: TREATMENT OF MS WITH AN ADMIXTURE OF (A) AN AMORPHOUS INCLUSION COMPLEX OF CLADRIBINE (2CDA) AND CYCLODEXTRIN AND (B) AMORPHOUS FREE 2CDA AND CYCLODEXTRIN AS A NON-INCLUSION COMPLEX, FORMULATED AS A SOLID ORAL FORM, W/O SIGN. AMOUNTS OF CRYST. 2CDA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Emd Serono Inc MAVENCLAD cladribine TABLET;ORAL 022561-001 Mar 29, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Emd Serono Inc MAVENCLAD cladribine TABLET;ORAL 022561-001 Mar 29, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Emd Serono Inc MAVENCLAD cladribine TABLET;ORAL 022561-001 Mar 29, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Emd Serono Inc MAVENCLAD cladribine TABLET;ORAL 022561-001 Mar 29, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Emd Serono Inc MAVENCLAD cladribine TABLET;ORAL 022561-001 Mar 29, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for MAVENCLAD

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Merck Europe B.V. Mavenclad cladribine EMEA/H/C/004230
Treatment of adult patients with highly active relapsing multiple sclerosis (MS) as defined by clinical or imaging features.
Authorised no no no 2017-08-22
Lipomed GmbH Litak cladribine EMEA/H/C/000504
Litak is indicated for the treatment of hairy-cell leukaemia.
Authorised no no no 2004-04-14
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for MAVENCLAD

See the table below for patents covering MAVENCLAD around the world.

Country Patent Number Title Estimated Expiration
Australia 2010214777 Oral formulations of cladribine ⤷  Sign Up
South Korea 20200090824 진행 형태의 다발성 경화증의 치료에서 사용을 위한 클라드리빈 용법 ⤷  Sign Up
European Patent Office 4070800 POSOLOGIE DE LA CLADRIBINE POUR LE TRAITEMENT DE LA SCLÉROSE EN PLAQUES (CLADRIBINE REGIMEN FOR TREATING MULTIPLE SCLEROSIS) ⤷  Sign Up
Brazil 122018068797 composições farmacêuticas de complexo de ciclodextrina-cladribina complexo, usos do referido complexo, bem como processos para a sua preparação ⤷  Sign Up
Spain 2428741 ⤷  Sign Up
Norway 20054945 ⤷  Sign Up
Argentina 106246 FORMULACIÓN FARMACÉUTICA DE CLADRIBINA PARA TRATAMIENTO DE ESCLEROSIS MÚLTIPLE Y USO ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for MAVENCLAD

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2805723 C20180006 00238 Estonia ⤷  Sign Up PRODUCT NAME: KLADRIBIIN;REG NO/DATE: EU/1/17/1212 24.08.2017
1608344 C 2018 009 Romania ⤷  Sign Up PRODUCT NAME: CLADRIBINA; NATIONAL AUTHORISATION NUMBER: EU/1/17/1212; DATE OF NATIONAL AUTHORISATION: 20170822; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1212; DATE OF FIRST AUTHORISATION IN EEA: 20170822
1608344 PA2018502 Lithuania ⤷  Sign Up PRODUCT NAME: KLADRIBINAS; REGISTRATION NO/DATE: EU1/17/1212/001-006 20170822
2805723 324 6-2018 Slovakia ⤷  Sign Up PRODUCT NAME: KLADRIBIN; REGISTRATION NO/DATE: EU/1/17/1212 20170824
1827461 122018000021 Germany ⤷  Sign Up PRODUCT NAME: CLADRIBIN; REGISTRATION NO/DATE: EU/1/17/1212 20170822
1827461 1890010-0 Sweden ⤷  Sign Up PRODUCT NAME: CLADRIBINE; REG. NO/DATE: EU/1/17/1212 20170824
1608344 C 2018 010 Romania ⤷  Sign Up PRODUCT NAME: CLADRIBINA; NATIONAL AUTHORISATION NUMBER: EU/1/17/1212; DATE OF NATIONAL AUTHORISATION: 20170822; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1212; DATE OF FIRST AUTHORISATION IN EEA: 20170822
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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