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Last Updated: May 6, 2024

SIPONIMOD - Generic Drug Details

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What are the generic sources for siponimod and what is the scope of patent protection?

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

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

One supplier is listed for this compound.

Summary for SIPONIMOD

International Patents:	142
US Patents:	2
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

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	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Novartis	MAYZENT	siponimod	TABLET;ORAL	209884-002	Mar 26, 2019		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
Novartis	MAYZENT	siponimod	TABLET;ORAL	209884-001	Mar 26, 2019		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
>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.	⤷ Try a Trial
Iceland	8153	Ónæmisbælandi efnasambönd og efnablöndur	⤷ Try a Trial
Lithuania	PA2020513		⤷ Try a Trial
>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	20C1022	France	⤷ Try a Trial	PRODUCT NAME: SIPONIMOD; REGISTRATION NO/DATE: EU/1/19/1414 20200115
2379069	122020000025	Germany	⤷ Try a Trial	PRODUCT NAME: SIPONIMOD; REGISTRATION NO/DATE: EU/1/19/1414 20200113
2379069	2020/022	Ireland	⤷ Try a Trial	PRODUCT NAME: SIPONIMOD; REGISTRATION NO/DATE: EU/1/19/1414 20200113
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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