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Last Updated: June 16, 2021

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MAYZENT Drug 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.

This drug has one hundred and thirty-seven patent family members in thirty-eight countries.

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.

DrugPatentWatch® Generic Entry Outlook for Mayzent

Mayzent will be eligible for patent challenges on March 26, 2023. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 19, 2024. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for MAYZENT
International Patents:137
US Patents:2
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 10
Clinical Trials: 1
Patent Applications: 125
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 Generic Entry Opportunity 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
Novartis PharmaceuticalsPhase 4

See all MAYZENT clinical trials

US Patents and Regulatory Information for MAYZENT

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 fumaric acid TABLET;ORAL 209884-001 Mar 26, 2019 RX Yes No   Get Started Free   Get Started Free   Get Started Free
Novartis MAYZENT siponimod fumaric acid TABLET;ORAL 209884-002 Mar 26, 2019 RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
Novartis MAYZENT siponimod fumaric acid TABLET;ORAL 209884-001 Mar 26, 2019 RX Yes No   Get Started Free   Get Started Free Y Y   Get Started Free
Novartis MAYZENT siponimod fumaric acid TABLET;ORAL 209884-001 Mar 26, 2019 RX Yes No   Get Started Free   Get Started Free   Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for MAYZENT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2379069 LUC00160 Luxembourg   Get Started Free PRODUCT NAME: SIPONIMOD; AUTHORISATION NUMBER AND DATE: EU/1/19/1414 20200115
2379069 21/2020 Austria   Get Started Free PRODUCT NAME: SIPONIMOD; REGISTRATION NO/DATE: EU/1/19/1414 (MITTEILUNG) 20200115
2379069 122020000025 Germany   Get Started Free PRODUCT NAME: SIPONIMOD; REGISTRATION NO/DATE: EU/1/19/1414 20200113
2379069 CA 2020 00026 Denmark   Get Started Free PRODUCT NAME: SIPONIMOD; REG. NO/DATE: EU/1/19/1414 20200115
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.