➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

AstraZeneca
McKinsey
Merck
Colorcon
Mallinckrodt
Express Scripts

Last Updated: July 7, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 209884


Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

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 two patents protecting this drug. Additional details are available on the MAYZENT profile page.

The generic ingredient in MAYZENT is siponimod fumaric acid. One supplier is listed for this compound. Additional details are available on the siponimod fumaric acid profile page.
Summary for 209884
Tradename:MAYZENT
Applicant:Novartis
Ingredient:siponimod fumaric acid
Patents:2
Generic Entry Opportunity 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.

Suppliers and Packaging for NDA: 209884
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MAYZENT siponimod fumaric acid 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 fumaric acid 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:RXDosage:TABLET;ORALStrengthEQ 0.25MG BASE
Approval Date:Mar 26, 2019TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 26, 2024
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:  Start TrialPatent Expiration:May 19, 2024Product Flag?YSubstance Flag?YDelist Request?
Patent:  Start TrialPatent Expiration:Nov 30, 2030Product Flag?Substance Flag?Delist Request?
Patented Use:A METHOD OF TREATING MULTIPLE SCLEROSIS BY ADMINISTERING SIPONIMOD USING A TITRATION SCHEME TO REACH A MAINTENANCE DOSE

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Medtronic
Boehringer Ingelheim
Colorcon
AstraZeneca
Johnson and Johnson
Dow

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.