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Last Updated: March 29, 2024

CLADRIBINE - Generic Drug Details


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What are the generic drug sources for cladribine and what is the scope of patent protection?

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

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

SponsorPhase
University of FloridaPhase 2
Affiliated Hospital of Nantong UniversityPhase 2
Northern Jiangsu Province People's HospitalN/A

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
Emd Serono Inc MAVENCLAD cladribine TABLET;ORAL 022561-001 Mar 29, 2019 RX Yes Yes ⤷  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
World Intellectual Property Organization (WIPO) 2019101960 ⤷  Try a Trial
Denmark 2805723 ⤷  Try a Trial
Russian Federation 2005133196 ПЕРОРАЛЬНЫЕ ПРЕПАРАТИВНЫЕ ФОРМЫ КЛАДРИБИНА ⤷  Try a Trial
Iceland 8051 Kladríbínefnablöndur til inngjafar um munn ⤷  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
1608344 PA2018502,C1608344 Lithuania ⤷  Try a Trial PRODUCT NAME: KLADRIBINAS; REGISTRATION NO/DATE: EU1/17/1212/001-006 20170822
1608344 C 2018 010 Romania ⤷  Try a Trial 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
2805723 C20180006 00238 Estonia ⤷  Try a Trial PRODUCT NAME: KLADRIBIIN;REG NO/DATE: EU/1/17/1212 24.08.2017
2805723 PA2018503 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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