Details for New Drug Application (NDA): 209884
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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 26, 2024 | ||||||||
Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
Regulatory Exclusivity Expiration: | Mar 1, 2025 | ||||||||
Regulatory Exclusivity Use: | REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY CBAF312A2130 | ||||||||
Patent: | ⤷ Try a Trial | Patent Expiration: | Aug 27, 2028 | Product Flag? | Y | Substance Flag? | Y | Delist Request? |
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