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MAYZENT Drug Patent Profile

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-two 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

Summary for MAYZENT

International Patents:	142
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

See drug prices for MAYZENT

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

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

Anatomical Therapeutic Chemical (ATC) Classes for MAYZENT

L04AA	Selective immunosuppressants
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

L04AE	Sphingosine-1-phosphate (S1P) receptor modulators
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

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.

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

FDA Regulatory Exclusivity protecting 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	TABLET;ORAL	209884-001	Mar 26, 2019		RX	Yes	No
Novartis	MAYZENT	siponimod	TABLET;ORAL	209884-003	Aug 24, 2021		RX	Yes	No
Novartis	MAYZENT	siponimod	TABLET;ORAL	209884-001	Mar 26, 2019		RX	Yes	No
Novartis	MAYZENT	siponimod	TABLET;ORAL	209884-002	Mar 26, 2019		RX	Yes	Yes
Novartis	MAYZENT	siponimod	TABLET;ORAL	209884-003	Aug 24, 2021		RX	Yes	No

International Patents for MAYZENT

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

Country	Patent Number	Title	Estimated Expiration
China	102264363
Tunisia	2011000281	DOSAGE REGIMEN OF AN S1P RECEPTOR AGONIST
Taiwan	200505442	Immunosuppressant compounds and compositions
European Patent Office	2379069	POSOLOGIE D'UN AGONISTE DU RÉCEPTEUR S1P (DOSAGE REGIMEN OF AN S1P RECEPTOR AGONIST)
Canada	2747992	REGIME POSOLOGIQUE D'UN AGONISTE DU RECEPTEUR S1P (DOSAGE REGIMEN OF AN S1P RECEPTOR AGONIST)

Supplementary Protection Certificates for MAYZENT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2379069	2020/022	Ireland		PRODUCT NAME: SIPONIMOD; REGISTRATION NO/DATE: EU/1/19/1414 20200113
2379069	C20200016 00335	Estonia		PRODUCT NAME: SIPONIMOOD;REG NO/DATE: EU/1/19/1414 15.01.2020
2379069	21/2020	Austria		PRODUCT NAME: SIPONIMOD; REGISTRATION NO/DATE: EU/1/19/1414 (MITTEILUNG) 20200115
2379069	20C1022	France		PRODUCT NAME: SIPONIMOD; REGISTRATION NO/DATE: EU/1/19/1414 20200115
2379069	2090022-1	Sweden		PRODUCT NAME: SIPONIMOD; REG. NO/DATE: EU/1/19/1414 20200115