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Last Updated: December 2, 2020

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MAVENCLAD Drug Profile

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Which patents cover Mavenclad, and when can generic versions of Mavenclad launch?

Mavenclad is a drug marketed by Emd Serono Inc and is included in one NDA. There are four patents protecting this drug.

This drug has one hundred and twenty-six patent family members in thirty-three countries.

The generic ingredient in MAVENCLAD is cladribine. There are eight drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the cladribine profile page.

US ANDA Litigation and Generic Entry Outlook for Mavenclad

A generic version of MAVENCLAD was approved as cladribine by WEST-WARD PHARMS INT on February 28th, 2000.

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Drug patent expirations by year for MAVENCLAD
Drug Prices for MAVENCLAD

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Recent Clinical Trials for MAVENCLAD

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

Keith Edwards, M.D.Phase 4
EMD SeronoPhase 4
University of Texas Southwestern Medical CenterPhase 4

See all MAVENCLAD clinical trials

Pharmacology for MAVENCLAD

US Patents and Regulatory Information for MAVENCLAD

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   Start Trial   Start Trial Y   Start Trial
Emd Serono Inc MAVENCLAD cladribine TABLET;ORAL 022561-001 Mar 29, 2019 RX Yes Yes   Start Trial   Start Trial Y   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 MAVENCLAD

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1827461 1890010-0 Sweden   Start Trial PRODUCT NAME: CLADRIBINE; REG. NO/DATE: EU/1/17/1212 20170824
1827461 C01827461/01 Switzerland   Start Trial PRODUCT NAME: CLADRIBIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66831 19.03.2019
1827461 132018000000141 Italy   Start Trial 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:

Johnson and Johnson
Express Scripts

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