Details for New Drug Application (NDA): 209884
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NDA 209884 describes MAYZENT, which is a drug marketed by Novartis 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 MAYZENT profile page.
The generic ingredient in MAYZENT is siponimod. One supplier is listed for this compound. Additional details are available on the siponimod profile page.
The generic ingredient in MAYZENT is siponimod. One supplier is listed for this compound. Additional details are available on the siponimod profile page.
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 209884
Generic Entry Date for 209884*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 209884
| Mechanism of Action | Sphingosine 1-Phosphate Receptor Modulators |
Suppliers and Packaging for NDA: 209884
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MAYZENT | siponimod | TABLET;ORAL | 209884 | NDA | Novartis Pharmaceuticals Corporation | 0078-0979 | 0078-0979-12 | 12 TABLET, FILM COATED in 1 BLISTER PACK (0078-0979-12) |
| MAYZENT | siponimod | TABLET;ORAL | 209884 | NDA | Novartis Pharmaceuticals Corporation | 0078-0979 | 0078-0979-50 | 28 TABLET, FILM COATED in 1 BOTTLE (0078-0979-50) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 0.25MG BASE | ||||
| Approval Date: | Mar 26, 2019 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Mar 1, 2025 | ||||||||
| Regulatory Exclusivity Use: | REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY CBAF312A2130 | ||||||||
| Patent: | 11,944,602 | Patent Expiration: | Apr 23, 2036 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS RECEIVING OR WHO MAY RECEIVE A BETA-BLOCKER TREATMENT | ||||||||
| Patent: | 12,071,402 | Patent Expiration: | Jan 5, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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