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Last Updated: January 30, 2023

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-one patent family members in thirty-four 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
Affiliated Hospital of Nantong UniversityN/A
Jining Medical UniversityPhase 2
The Second People's Hospital of Huai'anN/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
Hisun Pharm Hangzhou CLADRIBINE cladribine INJECTABLE;INJECTION 210856-001 Nov 25, 2019 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Fresenius Kabi Usa CLADRIBINE cladribine INJECTABLE;INJECTION 076571-001 Apr 22, 2004 AP RX No 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 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

Supplementary Protection Certificates for cladribine

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1608344 C 2018 009 Romania See Plans and Pricing 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 LUC00065 Luxembourg See Plans and Pricing PRODUCT NAME: CLADRIBINE; AUTHORISATION NUMBER AND DATE: EU/1/17/1212 20170824
1827461 CR 2018 00010 Denmark See Plans and Pricing 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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