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Last Updated: April 22, 2024

MAVENCLAD Drug Patent Profile


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Which patents cover Mavenclad, and when can generic versions of Mavenclad launch?

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-one 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
Queen Mary University of LondonPhase 2/Phase 3
University of EdinburghPhase 2/Phase 3
University of PlymouthPhase 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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Emd Serono Inc MAVENCLAD cladribine TABLET;ORAL 022561-001 Mar 29, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Emd Serono Inc MAVENCLAD cladribine TABLET;ORAL 022561-001 Mar 29, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Emd Serono Inc MAVENCLAD cladribine TABLET;ORAL 022561-001 Mar 29, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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
South Korea 20070091662 CLADRIBINE REGIMEN FOR TREATING MULTIPLE SCLEROSIS ⤷  Try a Trial
Germany 602004028448 ⤷  Try a Trial
European Patent Office 1608344 FORMULATIONS DE LA CLADRIBINE A ADMINISTRATION PAR VOIE ORALE (ORAL FORMULATIONS OF CLADRIBINE) ⤷  Try a Trial
Austria 476177 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for MAVENCLAD

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2805723 PA2018503 Lithuania ⤷  Try a Trial PRODUCT NAME: KLADRIBINAS; REGISTRATION NO/DATE: EU1/17/1212/001-006 20170822
1608344 PA2018502,C1608344 Lithuania ⤷  Try a Trial PRODUCT NAME: KLADRIBINAS; REGISTRATION NO/DATE: EU1/17/1212/001-006 20170822
1827461 122018000021 Germany ⤷  Try a Trial PRODUCT NAME: CLADRIBIN; REGISTRATION NO/DATE: EU/1/17/1212 20170822
1827461 1890010-0 Sweden ⤷  Try a Trial PRODUCT NAME: CLADRIBINE; REG. NO/DATE: EU/1/17/1212 20170824
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.