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Last Updated: September 27, 2022

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 four patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in MAVENCLAD is cladribine. There are eight drug master file entries for this compound. Five 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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Summary for MAVENCLAD
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
University of LeedsPhase 2/Phase 3
The Leeds Teaching Hospitals NHS TrustPhase 2/Phase 3
Queen Mary University of LondonPhase 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 four US patents and one FDA Regulatory Exclusivity.

Patents protecting MAVENCLAD

Cladribine regimen for treating multiple sclerosis
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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

FDA Regulatory Exclusivity protecting MAVENCLAD

NEW PRODUCT
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Emd Serono Inc MAVENCLAD cladribine TABLET;ORAL 022561-001 Mar 29, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Emd Serono Inc MAVENCLAD cladribine TABLET;ORAL 022561-001 Mar 29, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Emd Serono Inc MAVENCLAD cladribine TABLET;ORAL 022561-001 Mar 29, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Emd Serono Inc MAVENCLAD cladribine TABLET;ORAL 022561-001 Mar 29, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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
Norway 20073813 See Plans and Pricing
Montenegro P34308 ORALNE FORMULACIJE KLADRIBINA (ORAL FORMULATIONS OF CLADRIBINE) See Plans and Pricing
European Patent Office 1827461 RÉGIME POSOLOGIQUE DE CLADRIBINE POUR LE TRAITEMENT DE LA SCLÉROSE EN PLAQUES (CLADRIBINE REGIMEN FOR TREATING MULTIPLE SCLEROSIS) See Plans and Pricing
Iceland 8051 Kladríbínefnablöndur til inngjafar um munn See Plans and Pricing
Denmark 1608344 See Plans and Pricing
Slovenia 2805723 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for MAVENCLAD

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2805723 PA2018503,C2805723 Lithuania See Plans and Pricing PRODUCT NAME: KLADRIBINAS; REGISTRATION NO/DATE: EU1/17/1212/001-006 20170822
1827461 300930 Netherlands See Plans and Pricing PRODUCT NAME: CLADRIBINE; REGISTRATION NO/DATE: EU/1/17/1212 20170824
1827461 132018000000141 Italy See Plans and Pricing PRODUCT NAME: CLADRIBINA(MAVENCLAD); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1212, 20170824
1608344 LUC00065 Luxembourg See Plans and Pricing PRODUCT NAME: CLADRIBINE; AUTHORISATION NUMBER AND DATE: EU/1/17/1212 20170824
1827461 9/2018 Austria See Plans and Pricing PRODUCT NAME: CLADRIBIN; REGISTRATION NO/DATE: EU/1/17/1212 20170824
1608344 PA2018502,C1608344 Lithuania See Plans and Pricing PRODUCT NAME: KLADRIBINAS; REGISTRATION NO/DATE: EU1/17/1212/001-006 20170822
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Johnson and Johnson
AstraZeneca
Mallinckrodt
McKinsey
Express Scripts

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.