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.

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

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

See drug prices for MAYZENT

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for MAYZENT

Constraining patent/regulatory exclusivity:

REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY CBAF312A2130

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

Anatomical Therapeutic Chemical (ATC) Classes for MAYZENT

D05AX	Other antipsoriatics for topical use
D05A	ANTIPSORIATICS FOR TOPICAL USE
D05	ANTIPSORIATICS
D	Dermatologicals

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

US Patents and Regulatory Information for MAYZENT

MAYZENT is protected by two US patents and two FDA Regulatory Exclusivities.

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

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

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

Australia

Austria

Brazil

Canada

Chile

China

Croatia

Cyprus

Denmark

Ecuador

European Patent Office

Hong Kong

Hungary

Iceland

Israel

Japan

Lithuania

Malaysia

Mexico

Morocco

New Zealand

Norway

Peru

Poland

Portugal

Russian Federation

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

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
Brazil	PI0410746	compostos e composições imunossupressoras
Malaysia	150088	IMMUNOSUPPRESSANT COMPOUNDS AND COMPOSITIONS
Norway	334457
Hungary	E030772
Slovenia	2379069
Japan	4944613

Supplementary Protection Certificates for MAYZENT

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