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Last Updated: October 25, 2020

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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-six patent family members in thirty-three countries.

There are eight drug master file entries for cladribine. Five 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 Texas Southwestern Medical CenterPhase 4
EMD SeronoPhase 4
University of WashingtonPhase 1

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
Hisun Pharm Hangzhou CLADRIBINE cladribine INJECTABLE;INJECTION 210856-001 Nov 25, 2019 AP RX No No   Start Trial   Start Trial   Start Trial
Janssen Pharms LEUSTATIN cladribine INJECTABLE;INJECTION 020229-001 Feb 26, 1993 DISCN Yes No   Start Trial   Start Trial   Start Trial
Emd Serono Inc MAVENCLAD cladribine TABLET;ORAL 022561-001 Mar 29, 2019 RX Yes Yes   Start Trial   Start Trial   Start 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
1608344 PA2018502 Lithuania   Start Trial PRODUCT NAME: KLADRIBINAS; REGISTRATION NO/DATE: EU1/17/1212/001-006 20170822
1608344 LUC00065 Luxembourg   Start Trial PRODUCT NAME: CLADRIBINE; AUTHORISATION NUMBER AND DATE: EU/1/17/1212 20170824
1827461 C01827461/01 Switzerland   Start Trial PRODUCT NAME: CLADRIBIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66831 19.03.2019
>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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