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Last Updated: October 24, 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 freedom to operate?

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 ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Emd Serono Inc MAVENCLAD cladribine TABLET;ORAL 022561-001 Mar 29, 2019 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Fresenius Kabi Usa CLADRIBINE cladribine INJECTABLE;INJECTION 076571-001 Apr 22, 2004 AP RX No Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
West-ward Pharms Int CLADRIBINE cladribine INJECTABLE;INJECTION 075405-001 Feb 28, 2000 AP RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Emd Serono Inc MAVENCLAD cladribine TABLET;ORAL 022561-001 Mar 29, 2019 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
>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 18C1008 France ⤷  Free Forever Trial PRODUCT NAME: CLADRIBINE; REGISTRATION NO/DATE: EU/1/17/1212 20170824
1608344 C 2018 010 Romania ⤷  Free Forever 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 PA2018503 Lithuania ⤷  Free Forever Trial PRODUCT NAME: KLADRIBINAS; REGISTRATION NO/DATE: EU1/17/1212/001-006 20170822
1608344 C 2018 009 Romania ⤷  Free Forever 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
1827461 122018000021 Germany ⤷  Free Forever Trial PRODUCT NAME: CLADRIBIN; REGISTRATION NO/DATE: EU/1/17/1212 20170822
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
McKesson
Johnson and Johnson
Harvard Business School
Baxter
Merck

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