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. Six 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. Six 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 |
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: | AB | RLD: | Yes | ||||
| Patent: | ⤷ Get Started Free | 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: | ⤷ Get Started Free | Patent Expiration: | Sep 10, 2041 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS IN ADULTS BY ADMINISTERING 2 YEARLY TREATMENT COURSES WHEREIN PATIENTS WHO ARE SEROPOSITIVE TO VZV ARE VACCINATED WITH ZOSTER VACCINE RECOMBINANT, ADJUVANTED BETWEEN THE 1ST AND 2ND TREATMENT COURSE | ||||||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Sep 10, 2041 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF RELAPSING FORMS OF MS IN ADULTS BY ADMINISTERING 2 YEARLY TREATMENT COURSES WHEREIN PATIENTS WHO ARE SEROPOSITIVE TO VZV ARE VACCINATED WITH ZOSTER VACCINE RECOMBINANT, ADJUVANTED WITHIN ABOUT 4 WEEKS PRIOR TO THE 1ST TREATMENT COURSE | ||||||||
Expired US Patents for NDA 022561
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Emd Serono Inc | MAVENCLAD | cladribine | TABLET;ORAL | 022561-001 | Mar 29, 2019 | ⤷ Get Started Free | ⤷ Get Started Free |
| Emd Serono Inc | MAVENCLAD | cladribine | TABLET;ORAL | 022561-001 | Mar 29, 2019 | ⤷ Get Started Free | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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