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Last Updated: June 28, 2022

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.

This drug has one hundred and thirty-eight patent family members in thirty-nine 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 March 1, 2025. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for MAYZENT
International Patents:138
US Patents:2
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 9
Clinical Trials: 3
Patent Applications: 167
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:
REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY CBAF312A2130
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

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 See Plans and Pricing.

This potential generic entry date is based on REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY CBAF312A2130.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Dosage regimen of an S1P receptor agonist
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing

REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY CBAF312A2130
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novartis MAYZENT siponimod fumaric acid TABLET;ORAL 209884-003 Aug 24, 2021 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novartis MAYZENT siponimod fumaric acid TABLET;ORAL 209884-001 Mar 26, 2019 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novartis MAYZENT siponimod fumaric acid TABLET;ORAL 209884-002 Mar 26, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novartis MAYZENT siponimod fumaric acid TABLET;ORAL 209884-003 Aug 24, 2021 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novartis MAYZENT siponimod fumaric acid TABLET;ORAL 209884-001 Mar 26, 2019 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Novartis MAYZENT siponimod fumaric acid TABLET;ORAL 209884-001 Mar 26, 2019 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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

When does loss-of-exclusivity occur for MAYZENT?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 4402
Estimated Expiration: See Plans and Pricing

Patent: 4403
Estimated Expiration: See Plans and Pricing

Australia

Patent: 04240637
Estimated Expiration: See Plans and Pricing

Patent: 04240649
Estimated Expiration: See Plans and Pricing

Patent: 04249664
Estimated Expiration: See Plans and Pricing

Patent: 04251146
Estimated Expiration: See Plans and Pricing

Patent: 08203087
Estimated Expiration: See Plans and Pricing

Patent: 08203088
Estimated Expiration: See Plans and Pricing

Patent: 09200338
Estimated Expiration: See Plans and Pricing

Patent: 09200362
Estimated Expiration: See Plans and Pricing

Patent: 11224085
Estimated Expiration: See Plans and Pricing

Patent: 11224087
Estimated Expiration: See Plans and Pricing

Austria

Patent: 7825
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0410439
Estimated Expiration: See Plans and Pricing

Patent: 0410454
Estimated Expiration: See Plans and Pricing

Patent: 0410741
Estimated Expiration: See Plans and Pricing

Patent: 0410746
Estimated Expiration: See Plans and Pricing

Canada

Patent: 24027
Estimated Expiration: See Plans and Pricing

Patent: 24047
Estimated Expiration: See Plans and Pricing

Patent: 24048
Estimated Expiration: See Plans and Pricing

Patent: 24054
Estimated Expiration: See Plans and Pricing

Chile

Patent: 04001119
Estimated Expiration: See Plans and Pricing

Patent: 04001120
Estimated Expiration: See Plans and Pricing

China

Patent: 87817
Estimated Expiration: See Plans and Pricing

Patent: 91395
Estimated Expiration: See Plans and Pricing

Patent: 91592
Estimated Expiration: See Plans and Pricing

Patent: 16544
Estimated Expiration: See Plans and Pricing

Patent: 2174042
Estimated Expiration: See Plans and Pricing

Patent: 2875413
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0161156
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 12505
Estimated Expiration: See Plans and Pricing

Patent: 18299
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 33336
Estimated Expiration: See Plans and Pricing

Patent: 38551
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 056148
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 28967
Estimated Expiration: See Plans and Pricing

Patent: 33336
Estimated Expiration: See Plans and Pricing

Patent: 38551
Estimated Expiration: See Plans and Pricing

Patent: 44367
Estimated Expiration: See Plans and Pricing

Patent: 14743
Estimated Expiration: See Plans and Pricing

Patent: 44195
Estimated Expiration: See Plans and Pricing

Patent: 38835
Estimated Expiration: See Plans and Pricing

Patent: 72736
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 87929
Estimated Expiration: See Plans and Pricing

Patent: 90559
Estimated Expiration: See Plans and Pricing

Patent: 90639
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 30772
Estimated Expiration: See Plans and Pricing

Iceland

Patent: 07
Estimated Expiration: See Plans and Pricing

Patent: 53
Estimated Expiration: See Plans and Pricing

Israel

Patent: 1683
Estimated Expiration: See Plans and Pricing

Japan

Patent: 75920
Estimated Expiration: See Plans and Pricing

Patent: 00616
Estimated Expiration: See Plans and Pricing

Patent: 28962
Estimated Expiration: See Plans and Pricing

Patent: 44613
Estimated Expiration: See Plans and Pricing

Patent: 06528698
Estimated Expiration: See Plans and Pricing

Patent: 06528987
Estimated Expiration: See Plans and Pricing

Patent: 07501860
Estimated Expiration: See Plans and Pricing

Patent: 07503468
Estimated Expiration: See Plans and Pricing

Patent: 11012069
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 33336
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 0088
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 05012459
Estimated Expiration: See Plans and Pricing

Patent: 05012460
Estimated Expiration: See Plans and Pricing

Patent: 05012461
Estimated Expiration: See Plans and Pricing

Patent: 05012462
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 807
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 3241
Estimated Expiration: See Plans and Pricing

Norway

Patent: 4457
Estimated Expiration: See Plans and Pricing

Patent: 055837
Estimated Expiration: See Plans and Pricing

Peru

Patent: 050158
Estimated Expiration: See Plans and Pricing

Patent: 050626
Estimated Expiration: See Plans and Pricing

Poland

Patent: 33336
Estimated Expiration: See Plans and Pricing

Patent: 38551
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 33336
Estimated Expiration: See Plans and Pricing

Patent: 38551
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 05768
Estimated Expiration: See Plans and Pricing

Patent: 05139526
Estimated Expiration: See Plans and Pricing

Patent: 09132108
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 33336
Estimated Expiration: See Plans and Pricing

Patent: 38551
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0508203
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1118779
Estimated Expiration: See Plans and Pricing

Patent: 060017797
Estimated Expiration: See Plans and Pricing

Spain

Patent: 79169
Estimated Expiration: See Plans and Pricing

Patent: 67160
Estimated Expiration: See Plans and Pricing

Patent: 58761
Estimated Expiration: See Plans and Pricing

Patent: 93463
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 55931
Estimated Expiration: See Plans and Pricing

Patent: 0505428
Estimated Expiration: See Plans and Pricing

Patent: 0505442
Estimated Expiration: See Plans and Pricing

Tunisia

Patent: 05294
Estimated Expiration: See Plans and Pricing

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

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

Country Patent Number Title Estimated Expiration
Japan 2007503468 See Plans and Pricing
Brazil PI0410746 compostos e composições imunossupressoras See Plans and Pricing
Malaysia 150088 IMMUNOSUPPRESSANT COMPOUNDS AND COMPOSITIONS See Plans and Pricing
Norway 334457 See Plans and Pricing
Hungary E030772 See Plans and Pricing
Slovenia 2379069 See Plans and Pricing
Japan 4944613 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for MAYZENT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2379069 21/2020 Austria See Plans and Pricing PRODUCT NAME: SIPONIMOD; REGISTRATION NO/DATE: EU/1/19/1414 (MITTEILUNG) 20200115
2379069 122020000025 Germany See Plans and Pricing PRODUCT NAME: SIPONIMOD; REGISTRATION NO/DATE: EU/1/19/1414 20200113
2379069 LUC00160 Luxembourg See Plans and Pricing PRODUCT NAME: SIPONIMOD; AUTHORISATION NUMBER AND DATE: EU/1/19/1414 20200115
2379069 CA 2020 00026 Denmark See Plans and Pricing PRODUCT NAME: SIPONIMOD; REG. NO/DATE: EU/1/19/1414 20200115
2379069 2020C/526 Belgium See Plans and Pricing PRODUCT NAME: SIPONIMOD; AUTHORISATION NUMBER AND DATE: EU/1/19/1414 20200115
2379069 2020/022 Ireland See Plans and Pricing PRODUCT NAME: SIPONIMOD; REGISTRATION NO/DATE: EU/1/19/1414 20200113
2379069 C02379069/01 Switzerland See Plans and Pricing PRODUCT NAME: SIPONIMOD; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67230 22.10.2020
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Dow
Merck
AstraZeneca
McKesson
Express Scripts
McKinsey

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.