~ Buy the MAYZENT (siponimod) Drug Profile, 2024 PDF Report in the Report Store ~

MAYZENT Drug Patent Profile

✉ Email this page to a colleague

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-three patent family members in forty-four 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

< Available with Subscription >

Sign Up

AI Research Assistant

Questions you can ask:

What is the 5 year forecast for MAYZENT?
What are the global sales for MAYZENT?
What is Average Wholesale Price for MAYZENT?

Summary for MAYZENT

International Patents:	193
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	63
Clinical Trials:	3
Patent Applications:	271
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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for MAYZENT

Generic Entry Date for MAYZENT^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up NDA: 209884 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

See all MAYZENT clinical trials

Pharmacology for MAYZENT

Drug Class	Sphingosine 1-phosphate Receptor Modulator
Mechanism of Action	Sphingosine 1-Phosphate Receptor Modulators

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 four US patents and two FDA Regulatory Exclusivities.

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

This potential generic entry date is based on patent ⤷ Sign Up.
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

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS RECEIVING OR WHO MAY RECEIVE A BETA-BLOCKER TREATMENT

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Immunosuppresant compounds and compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Dosage regimen of an S1P receptor agonist
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up

REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY CBAF312A2130
Exclusivity Expiration: ⤷ Sign Up

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Sign Up
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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novartis	MAYZENT	siponimod	TABLET;ORAL	209884-002	Mar 26, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novartis	MAYZENT	siponimod	TABLET;ORAL	209884-003	Aug 24, 2021		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novartis	MAYZENT	siponimod	TABLET;ORAL	209884-001	Mar 26, 2019		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Novartis	MAYZENT	siponimod	TABLET;ORAL	209884-003	Aug 24, 2021		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novartis	MAYZENT	siponimod	TABLET;ORAL	209884-003	Aug 24, 2021		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novartis	MAYZENT	siponimod	TABLET;ORAL	209884-002	Mar 26, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>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.

Subscribe to access the full database, or Sign Up
Country	Patent Number	Title	Estimated Expiration
Cyprus	2020014		⤷ Sign Up
China	103458877	Immunosuppressant formulations	⤷ Sign Up
Iceland	8153	Ónæmisbælandi efnasambönd og efnablöndur	⤷ Sign Up
Tunisia	SN05294	IMMUNOSUPPRESSANT COMPOUNDS AND COMPOSITIONS	⤷ Sign Up
Hungary	S2000017		⤷ Sign Up
Canada	2524054	COMPOSES IMMUNOSUPPRESSEURS ET COMPOSITIONS (IMMUNOSUPPRESSANT COMPOUNDS AND COMPOSITIONS)	⤷ Sign Up
Portugal	2379069		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for MAYZENT

Subscribe to access the full database, or Sign Up
Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2379069	C202030029	Spain	⤷ Sign Up	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	CR 2020 00026	Denmark	⤷ Sign Up	PRODUCT NAME: SIPONIMOD; REG. NO/DATE: EU/1/19/1414 20200115
2379069	SPC/GB20/026	United Kingdom	⤷ Sign Up	PRODUCT NAME: SIPONIMOD; REGISTERED: UK EU/1/19/1414 (NI) 20200115; UK PLGB00101/1189 20200115; UK PLGB00101/1190 20200115
2379069	20C1022	France	⤷ Sign Up	PRODUCT NAME: SIPONIMOD; REGISTRATION NO/DATE: EU/1/19/1414 20200115
2379069	122020000025	Germany	⤷ Sign Up	PRODUCT NAME: SIPONIMOD; REGISTRATION NO/DATE: EU/1/19/1414 20200113
2379069	LUC00160	Luxembourg	⤷ Sign Up	PRODUCT NAME: SIPONIMOD; AUTHORISATION NUMBER AND DATE: EU/1/19/1414 20200115
2379069	21/2020	Austria	⤷ Sign Up	PRODUCT NAME: SIPONIMOD; REGISTRATION NO/DATE: EU/1/19/1414 (MITTEILUNG) 20200115
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description