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Last Updated: March 3, 2024

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MAYZENT Drug Patent Profile


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When do Mayzent patents expire, and what generic alternatives are available?

Mayzent is a drug marketed by Novartis and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and forty-one patent family members in forty countries.

The generic ingredient in MAYZENT is siponimod. One supplier is listed for this compound. Additional details are available on the siponimod profile page.

DrugPatentWatch® Generic Entry Outlook for Mayzent

Mayzent was eligible for patent challenges on March 26, 2023.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 27, 2028. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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Summary for MAYZENT
International Patents:141
US Patents:2
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 63
Clinical Trials: 3
Patent Applications: 309
Drug Prices: Drug price information for MAYZENT
What excipients (inactive ingredients) are in MAYZENT?MAYZENT excipients list
DailyMed Link:MAYZENT at DailyMed
Drug patent expirations by year for MAYZENT
Drug Prices for MAYZENT

See drug prices for MAYZENT

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for MAYZENT
Generic Entry Date for MAYZENT*:
Constraining patent/regulatory exclusivity:
NDA:
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.

Recent Clinical Trials for MAYZENT

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Robert Zivadinov, MD, PhDPhase 4
Novartis PharmaceuticalsPhase 4
Novartis PharmaceuticalsPhase 3

See all MAYZENT clinical trials

Pharmacology for MAYZENT
Paragraph IV (Patent) Challenges for MAYZENT
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
MAYZENT Tablets siponimod 0.25 mg, 1 mg and 2 mg 209884 5 2023-03-27

US Patents and Regulatory Information for MAYZENT

MAYZENT is protected by two US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of MAYZENT is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting MAYZENT

Immunosuppresant compounds and compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Dosage regimen of an S1P receptor agonist
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: A METHOD OF TREATING MULTIPLE SCLEROSIS BY ADMINISTERING SIPONIMOD USING A TITRATION SCHEME TO REACH A MAINTENANCE DOSE

FDA Regulatory Exclusivity protecting MAYZENT

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Try a Trial

REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY CBAF312A2130
Exclusivity Expiration: ⤷  Try a Trial

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis MAYZENT siponimod TABLET;ORAL 209884-001 Mar 26, 2019 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis MAYZENT siponimod TABLET;ORAL 209884-003 Aug 24, 2021 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis MAYZENT siponimod TABLET;ORAL 209884-001 Mar 26, 2019 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis MAYZENT siponimod TABLET;ORAL 209884-002 Mar 26, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis MAYZENT siponimod TABLET;ORAL 209884-003 Aug 24, 2021 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis MAYZENT siponimod TABLET;ORAL 209884-001 Mar 26, 2019 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Novartis MAYZENT siponimod TABLET;ORAL 209884-001 Mar 26, 2019 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for MAYZENT

See the table below for patents covering MAYZENT around the world.

Country Patent Number Title Estimated Expiration
Norway 334457 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2004113330 ⤷  Try a Trial
Japan 2012513378 ⤷  Try a Trial
European Patent Office 2379069 POSOLOGIE D'UN AGONISTE DU RÉCEPTEUR S1P (DOSAGE REGIMEN OF AN S1P RECEPTOR AGONIST) ⤷  Try a Trial
New Zealand 593427 DOSAGE REGIMEN OF AN S1P RECEPTOR AGONIST ⤷  Try a Trial
Australia 2004249664 Immunosuppressant compounds and compositions ⤷  Try a Trial
Lithuania PA2020513 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for MAYZENT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2379069 132020000000076 Italy ⤷  Try a Trial PRODUCT NAME: SIPONIMOD(MAYZENT ); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1414, 20200115
2379069 C202030029 Spain ⤷  Try a Trial PRODUCT NAME: SIPONIMOD; NATIONAL AUTHORISATION NUMBER: EU/1/19/1414; DATE OF AUTHORISATION: 20200113; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/19/1414; DATE OF FIRST AUTHORISATION IN EEA: 20200113
2379069 CA 2020 00026 Denmark ⤷  Try a Trial PRODUCT NAME: SIPONIMOD; REG. NO/DATE: EU/1/19/1414 20200115
2379069 2020017 Norway ⤷  Try a Trial PRODUCT NAME: SIPONIMOD; REG. NO/DATE: EU/1/19/1414 20200127
2379069 2020/022 Ireland ⤷  Try a Trial PRODUCT NAME: SIPONIMOD; REGISTRATION NO/DATE: EU/1/19/1414 20200113
2379069 20C1022 France ⤷  Try a Trial PRODUCT NAME: SIPONIMOD; REGISTRATION NO/DATE: EU/1/19/1414 20200115
2379069 LUC00160 Luxembourg ⤷  Try a Trial PRODUCT NAME: SIPONIMOD; AUTHORISATION NUMBER AND DATE: EU/1/19/1414 20200115
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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

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.