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 four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

One supplier is listed for this compound.

Summary for siponimod

International Patents:	193
US Patents:	4
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	209884-003	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				⤷ 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				⤷ 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	209884-001	Mar 26, 2019		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
Eurasian Patent Organization	201391018	ПРЕПАРАТЫ ИММУНОСУПРЕССАНТОВ	⤷ Sign Up
Japan	2006528698		⤷ Sign Up
New Zealand	593427	DOSAGE REGIMEN OF AN S1P RECEPTOR AGONIST	⤷ Sign Up
Taiwan	I583380		⤷ Sign Up
Spain	2558761		⤷ Sign Up
Australia	2009200362	Immunosuppressant compounds and compositions	⤷ 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	2020C/526	Belgium	⤷ Sign Up	PRODUCT NAME: SIPONIMOD; AUTHORISATION NUMBER AND DATE: EU/1/19/1414 20200115
2379069	PA2020513	Lithuania	⤷ Sign Up	PRODUCT NAME: SIPONIMODAS; REGISTRATION NO/DATE: EU/1/19/1414 20200113
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	20C1022	France	⤷ Sign Up	PRODUCT NAME: SIPONIMOD; REGISTRATION NO/DATE: EU/1/19/1414 20200115
2379069	2020017	Norway	⤷ Sign Up	PRODUCT NAME: SIPONIMOD; REG. NO/DATE: EU/1/19/1414 20200127
2379069	132020000000076	Italy	⤷ Sign Up	PRODUCT NAME: SIPONIMOD(MAYZENT ); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1414, 20200115
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.