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Last Updated: November 4, 2024

CLADRIBINE Drug Patent Profile


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DrugPatentWatch® Litigation and Generic Entry Outlook for Cladribine

A generic version of CLADRIBINE was approved as cladribine by HIKMA on February 28th, 2000.

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Drug patent expirations by year for CLADRIBINE
Drug Prices for CLADRIBINE

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Recent Clinical Trials for CLADRIBINE

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SponsorPhase
Institute of Hematology & Blood Diseases Hospital, ChinaPhase 2
University of FloridaPhase 2
The First Affiliated Hospital of Soochow UniversityN/A

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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
Fresenius Kabi Usa CLADRIBINE cladribine INJECTABLE;INJECTION 076571-001 Apr 22, 2004 AP RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Norvium Bioscience CLADRIBINE cladribine INJECTABLE;INJECTION 200510-001 Oct 6, 2011 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hikma CLADRIBINE cladribine INJECTABLE;INJECTION 075405-001 Feb 28, 2000 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hisun Pharm Hangzhou CLADRIBINE cladribine INJECTABLE;INJECTION 210856-001 Nov 25, 2019 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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

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