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 five 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. Four 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:	5

Pharmacology for NDA: 022561

Medical Subject Heading (MeSH) Categories for 022561

Antineoplastic Agents
Immunosuppressive Agents

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:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Mar 29, 2019	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Nov 23, 2038	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATING NON-EARLY SPMS BY ADMINISTERING ORAL CLADRIBINE AT A FIXED DOSE PER PATIENT, PER BODY WEIGHT AND PER TREATMENT YEAR, WHICH FIXED DOSE IS 1.75 +/- 0.2 MG/KG, TO BE ADMINISTERED WITHIN MONTHS 1 AND 2 IN EACH OF 2 ADJACENT TREATMENT YEARS
Patent:	⤷ Sign Up	Patent Expiration:	Oct 16, 2026	Product 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:	⤷ Sign Up	Patent Expiration:	Apr 11, 2024	Product Flag?	Y	Substance 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

Expired US Patents for NDA 022561

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Emd Serono Inc	MAVENCLAD	cladribine	TABLET;ORAL	022561-001	Mar 29, 2019	⤷ Sign Up	⤷ Sign Up
Emd Serono Inc	MAVENCLAD	cladribine	TABLET;ORAL	022561-001	Mar 29, 2019	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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