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Generated: September 20, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022561

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NDA 022561 describes MAVENCLAD, which is a drug marketed by Emd Serono Inc and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the MAVENCLAD profile page.

The generic ingredient in MAVENCLAD is cladribine. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the cladribine profile page.
Summary for 022561
Tradename:MAVENCLAD
Applicant:Emd Serono Inc
Ingredient:cladribine
Patents:4
Formulation / Manufacturing:see details
Pharmacology for NDA: 022561
Medical Subject Heading (MeSH) Categories for 022561
Suppliers and Packaging for NDA: 022561
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MAVENCLAD cladribine TABLET;ORAL 022561 NDA EMD Serono, Inc. 44087-4000 44087-4000-0 5 BLISTER PACK in 1 CARTON (44087-4000-0) > 2 TABLET in 1 BLISTER PACK
MAVENCLAD cladribine TABLET;ORAL 022561 NDA EMD Serono, Inc. 44087-4000 44087-4000-4 4 BLISTER PACK in 1 CARTON (44087-4000-4) > 1 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Mar 29, 2019TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 29, 2022
Regulatory Exclusivity Use:NEW PRODUCT
Patent:  Try a Free TrialPatent Expiration:Oct 16, 2026Product Flag?Substance Flag?Delist Request?
Patented Use:TREATING MS WITH ORAL CLADRIBINE ACC. TO THE STEPS (I) INDUCTION PERIOD WITH ABOUT 1.7 MG/KG-3.5 MG/KG CLADRIBINE; (II) CLADRIBINE-FREE PERIOD OF ABOUT 8-10 MONTHS; (III) MAINTENANCE PERIOD WITH ABOUT 1.7 MG/KG CLADRIBINE; (IV) CLADRIBINE-FREE PERIOD
Patent:  Try a Free TrialPatent Expiration:Apr 11, 2024Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF MS WITH A TABLET WITH AN ADMIXTURE OF (A) AN AMORPHOUS INCLUSION COMPLEX OF CLADRIBINE AND HYDROXYPROPYL-B-CYCLODEXTRIN AND (B) AMORPHOUS FREE CLADRIBINE AND CYCLODEXTRIN AS A NON-INCLUSION COMPLEX, CLADRIBINE/CYCLODEXTRIN 1:10-1:16 W/W

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