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Last Updated: July 10, 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 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-five 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

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SponsorPhase
EMD SeronoPhase 4
University of Texas Southwestern Medical CenterPhase 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
West-ward Pharms Int CLADRIBINE cladribine INJECTABLE;INJECTION 075405-001 Feb 28, 2000 AP RX No 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
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
1827461 2018C/010 Belgium   Start Trial PRODUCT NAME: CLADRIBINE; AUTHORISATION NUMBER AND DATE: EU/1/17/1212 20170824
1608344 PA2018502,C1608344 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Baxter
Mallinckrodt
Boehringer Ingelheim
AstraZeneca
Express Scripts
Medtronic

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