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Last Updated: October 23, 2021

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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, Hisun Pharm Hangzhou, Mylan Labs Ltd, West-ward Pharms Int, Janssen Pharms, and Emd Serono Inc, and is included in six NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cladribine has one hundred and twenty-eight patent family members in thirty-three countries.

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

Summary for CLADRIBINE
Drug Prices for CLADRIBINE

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Recent Clinical Trials for CLADRIBINE

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

SponsorPhase
LanZhou UniversityN/A
KCRIPhase 2
Maria Sklodowska-Curie Institute - Oncology CenterPhase 2

See all CLADRIBINE clinical trials

Pharmacology for CLADRIBINE
Medical Subject Heading (MeSH) Categories for CLADRIBINE

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 it Free ⤷  Try it Free ⤷  Try it Free
Mylan Labs Ltd CLADRIBINE cladribine INJECTABLE;INJECTION 200510-001 Oct 6, 2011 AP RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Emd Serono Inc MAVENCLAD cladribine TABLET;ORAL 022561-001 Mar 29, 2019 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Janssen Pharms LEUSTATIN cladribine INJECTABLE;INJECTION 020229-001 Feb 26, 1993 DISCN Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
West-ward Pharms Int CLADRIBINE cladribine INJECTABLE;INJECTION 075405-001 Feb 28, 2000 AP RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for CLADRIBINE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1827461 C201830015 Spain ⤷  Try it Free PRODUCT NAME: CLADRIBINA; NATIONAL AUTHORISATION NUMBER: EU/1/17/1212; DATE OF AUTHORISATION: 20170822; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1212; DATE OF FIRST AUTHORISATION IN EEA: 20170822
1827461 CR 2018 00010 Denmark ⤷  Try it Free PRODUCT NAME: CLADRIBINE; REG. NO/DATE: EU/1/17/1212 20170824
2805723 C20180006 00238 Estonia ⤷  Try it Free PRODUCT NAME: KLADRIBIIN;REG NO/DATE: EU/1/17/1212 24.08.2017
1827461 18C1008 France ⤷  Try it Free PRODUCT NAME: CLADRIBINE; REGISTRATION NO/DATE: EU/1/17/1212 20170824
1827461 132018000000141 Italy ⤷  Try it Free PRODUCT NAME: CLADRIBINA(MAVENCLAD); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1212, 20170824
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
Mallinckrodt
Boehringer Ingelheim
AstraZeneca
Express Scripts
Medtronic

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