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Last Updated: March 29, 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
Australia 2011224085 Immunosuppressant compounds and compositions ⤷  Try a Trial
Chile 2004001120 COMPUESTOS DERIVADOS DE AMINA SUSTITUIDAS CON HETEROCICLOS, INMUNOSUPRESORES; COMPOSICION FARMACEUTICA; Y USO PARA TRATAR ENFERMEDADES MEDIADAS POR INTERACCIONES DE LINFOCITO, TALES COMO ENFERMEDADES AUTOINMUNES, INFLAMATORIAS, INFECCIOSAS, CANCER. ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2010072703 ⤷  Try a Trial
Brazil PI0410454 composições e compostos imunossupressores ⤷  Try a Trial
Japan 2012513378 ⤷  Try a Trial
Japan 4728962 ⤷  Try a Trial
Brazil PI0923213 regime de dosagem de um agonista do receptor para s1p. ⤷  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 C20200016 00335 Estonia ⤷  Try a Trial PRODUCT NAME: SIPONIMOOD;REG NO/DATE: EU/1/19/1414 15.01.2020
2379069 C02379069/01 Switzerland ⤷  Try a Trial PRODUCT NAME: SIPONIMOD; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67230 22.10.2020
2379069 2090022-1 Sweden ⤷  Try a Trial PRODUCT NAME: SIPONIMOD; REG. NO/DATE: EU/1/19/1414 20200115
2379069 301046 Netherlands ⤷  Try a Trial PRODUCT NAME: SIPONIMOD; REGISTRATION 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 21/2020 Austria ⤷  Try a Trial PRODUCT NAME: SIPONIMOD; REGISTRATION NO/DATE: EU/1/19/1414 (MITTEILUNG) 20200115
2379069 132020000000076 Italy ⤷  Try a Trial PRODUCT NAME: SIPONIMOD(MAYZENT ); AUTHORISATION NUMBER(S) AND DATE(S): 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.