Siponimod - Generic Drug Details

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What are the generic drug sources for siponimod and what is the scope of freedom to operate?

Siponimod is the generic ingredient in one branded drug marketed by Novartis and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Siponimod has one hundred and forty-four patent family members in forty countries.

One supplier is listed for this compound.

Summary for siponimod

International Patents:	144
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	51
Clinical Trials:	9
Patent Applications:	236
What excipients (inactive ingredients) are in siponimod?	siponimod excipients list
DailyMed Link:	siponimod at DailyMed

Recent Clinical Trials for siponimod

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Robert Zivadinov, MD, PhD	Phase 4
Novartis Pharmaceuticals	Phase 4
Providence Health & Services	Early Phase 1

See all siponimod clinical trials

Pharmacology for siponimod

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

Anatomical Therapeutic Chemical (ATC) Classes for siponimod

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 SIPONIMOD

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 siponimod

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Glossary

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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	Y	Y		⤷ Sign Up
Novartis	MAYZENT	siponimod	TABLET;ORAL	209884-002	Mar 26, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Novartis	MAYZENT	siponimod	TABLET;ORAL	209884-003	Aug 24, 2021		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ 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 siponimod

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Country	Patent Number	Title	Estimated Expiration
Chile	2004001119	COMPUESTOS DERIVADOS DE OXIMAS; COMPOSICIONES FARMACEUTICA QUE LOS CONTIENEN; Y SU USO COMO INMUNOSUPRESORES UTILES EN ENFERMEDADES MEDIADAS POR EL RECEPTOR EDG, TALEES COMO ENFERMEDADES AUTOINMUNES, INFLAMATORIAS, INFECCIOSAS Y CANCER.	⤷ Sign Up
Hong Kong	1159524	受體激動劑的給藥方案 (DOSAGE REGIMEN OF AN S1P RECEPTOR AGONIST S1P)	⤷ Sign Up
Japan	5657565		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2016135644		⤷ Sign Up
South Korea	20110106399	DOSAGE REGIMEN OF AN S1P RECEPTOR AGONIST	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for siponimod

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2379069	CA 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	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	21/2020	Austria	⤷ Sign Up	PRODUCT NAME: SIPONIMOD; REGISTRATION NO/DATE: EU/1/19/1414 (MITTEILUNG) 20200115
2379069	20C1022	France	⤷ Sign Up	PRODUCT NAME: SIPONIMOD; REGISTRATION NO/DATE: EU/1/19/1414 20200115
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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