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.
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 |
| Formulation / Manufacturing: | see details |
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 | |||||
| Regulatory Exclusivity Expiration: | Mar 29, 2022 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | See Plans and Pricing | 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: | See Plans and Pricing | 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 | ||||||||
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