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Last Updated: February 22, 2024

Cladribine - Generic Drug Details

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What are the generic drug sources for cladribine and what is the scope of freedom to operate?

Cladribine is the generic ingredient in three branded drugs marketed by Fresenius Kabi Usa, Hikma, Hisun Pharm Hangzhou, Mylan Labs Ltd, Janssen Pharms, and Emd Serono Inc, and is included in six NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cladribine has one hundred and fifty patent family members in thirty-five countries.

There are eight drug master file entries for cladribine. Four suppliers are listed for this compound.

Drug Prices for cladribine

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Recent Clinical Trials for cladribine

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University of FloridaPhase 2
Jining Medical UniversityN/A
Suzhou Hospital of Traditional Chinese MedicinePhase 2

See all cladribine clinical trials

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

US Patents and Regulatory Information for cladribine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Labs Ltd CLADRIBINE cladribine INJECTABLE;INJECTION 200510-001 Oct 6, 2011 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Fresenius Kabi Usa CLADRIBINE cladribine INJECTABLE;INJECTION 076571-001 Apr 22, 2004 AP RX No 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 Y ⤷  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 cladribine

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 cladribine

Country Patent Number Title Estimated Expiration
Denmark 1827461 ⤷  Try a Trial
Croatia P20050925 ORAL FORMULATIONS OF CLADRIBINE ⤷  Try a Trial
European Patent Office 2275110 Régime posologique de cladribine pour le traitement de la sclérose en plaques (Cladribine regimen for treating Multiple Sclerosis) ⤷  Try a Trial
Lithuania C2805723 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for cladribine

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1827461 2018C/010 Belgium ⤷  Try a Trial PRODUCT NAME: CLADRIBINE; AUTHORISATION NUMBER AND DATE: EU/1/17/1212 20170824
1827461 122018000021 Germany ⤷  Try a Trial PRODUCT NAME: CLADRIBIN; REGISTRATION NO/DATE: EU/1/17/1212 20170822
1827461 132018000000141 Italy ⤷  Try a Trial PRODUCT NAME: CLADRIBINA(MAVENCLAD); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1212, 20170824
2805723 PA2018503,C2805723 Lithuania ⤷  Try a Trial 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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