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 four patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and ninety-four patent family members in forty-five 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® Litigation and Generic Entry Outlook for Mayzent
A generic version of MAYZENT was approved as siponimod by RICONPHARMA LLC on April 22nd, 2025.
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Questions you can ask:
- What is the 5 year forecast for MAYZENT?
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- What is Average Wholesale Price for MAYZENT?
Summary for MAYZENT
International Patents: | 194 |
US Patents: | 4 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 63 |
Clinical Trials: | 3 |
Patent Applications: | 499 |
Drug Prices: | Drug price information for MAYZENT |
What excipients (inactive ingredients) are in MAYZENT? | MAYZENT excipients list |
DailyMed Link: | MAYZENT at DailyMed |


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
Sponsor | Phase |
---|---|
Robert Zivadinov, MD, PhD | Phase 4 |
Novartis Pharmaceuticals | Phase 4 |
Novartis Pharmaceuticals | Phase 3 |
Pharmacology for MAYZENT
Drug Class | Sphingosine 1-phosphate Receptor Modulator |
Mechanism of Action | Sphingosine 1-Phosphate Receptor Modulators |
US Patents and Regulatory Information for MAYZENT
MAYZENT is protected by four US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of MAYZENT is ⤷ Try for Free.
This potential generic entry date is based on patent ⤷ Try for Free.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
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 | AB | RX | Yes | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | |||
Novartis | MAYZENT | siponimod | TABLET;ORAL | 209884-003 | Aug 24, 2021 | AB | RX | Yes | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | |||
Novartis | MAYZENT | siponimod | TABLET;ORAL | 209884-001 | Mar 26, 2019 | AB | RX | Yes | No | ⤷ Try for Free | ⤷ Try for Free | Y | ⤷ Try for Free | ||
Novartis | MAYZENT | siponimod | TABLET;ORAL | 209884-002 | Mar 26, 2019 | AB | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | |||
Novartis | MAYZENT | siponimod | TABLET;ORAL | 209884-003 | Aug 24, 2021 | AB | RX | Yes | No | ⤷ Try for Free | ⤷ Try for Free | Y | Y | ⤷ Try for Free | |
Novartis | MAYZENT | siponimod | TABLET;ORAL | 209884-002 | Mar 26, 2019 | AB | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | Y | ⤷ Try for Free | ||
Novartis | MAYZENT | siponimod | TABLET;ORAL | 209884-001 | Mar 26, 2019 | AB | RX | Yes | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | |||
>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 |
---|---|---|---|
Hong Kong | 1090559 | IMMUNOSUPPRESSANT COMPOUNDS AND COMPOSITIONS | ⤷ Try for Free |
Russian Federation | 2009132108 | ИММУНОДЕПРЕССАНТНЫЕ СОЕДИНЕНИЯ И КОМПОЗИЦИИ | ⤷ Try for Free |
Israel | 171683 | תרכובות מדכאות חיסון, תכשירים רפואיים המכילים אותן ושימושן בהכנת תרופות לטיפול (Immunosuppressant compounds, pharmaceutical compositions comprising them and use thereof in the preparation of medicaments for therapy) | ⤷ Try for Free |
Taiwan | 201249438 | Immunosuppressant formulations | ⤷ Try for Free |
Japan | 2007503468 | ⤷ Try for Free | |
Mexico | 2013007909 | FORMULACIONES INMUNOSUPRESORAS. (IMMUNOSUPPRESSANT FORMULATIONS.) | ⤷ Try for Free |
World Intellectual Property Organization (WIPO) | 2012093161 | ⤷ Try for Free | |
>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 for Free | PRODUCT NAME: SIPONIMOD(MAYZENT ); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1414, 20200115 |
2379069 | PA2020513 | Lithuania | ⤷ Try for Free | PRODUCT NAME: SIPONIMODAS; REGISTRATION NO/DATE: EU/1/19/1414 20200113 |
2379069 | SPC/GB20/026 | United Kingdom | ⤷ Try for Free | PRODUCT NAME: SIPONIMOD; REGISTERED: UK EU/1/19/1414 (NI) 20200115; UK PLGB00101/1189 20200115; UK PLGB00101/1190 20200115 |
2379069 | 2020017 | Norway | ⤷ Try for Free | PRODUCT NAME: SIPONIMOD; REG. NO/DATE: EU/1/19/1414 20200127 |
2379069 | PA2020513,C2379069 | Lithuania | ⤷ Try for Free | PRODUCT NAME: SIPONIMODAS; REGISTRATION NO/DATE: EU/1/19/1414 20200113 |
2379069 | C20200016 00335 | Estonia | ⤷ Try for Free | PRODUCT NAME: SIPONIMOOD;REG NO/DATE: EU/1/19/1414 15.01.2020 |
2379069 | 2020/022 | Ireland | ⤷ Try for Free | PRODUCT NAME: SIPONIMOD; REGISTRATION NO/DATE: EU/1/19/1414 20200113 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Market Dynamics and Financial Trajectory for Mayzent
More… ↓