Ponesimod - Generic Drug Details

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

Ponesimod is the generic ingredient in one branded drug marketed by Vanda Pharms Inc and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

Two suppliers are listed for this compound.

Summary for ponesimod

International Patents:	144
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	46
Clinical Trials:	9
Patent Applications:	93
What excipients (inactive ingredients) are in ponesimod?	ponesimod excipients list
DailyMed Link:	ponesimod at DailyMed

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

Generic Entry Date for ponesimod^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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 ponesimod

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

Sponsor	Phase
Janssen Pharmaceutica N.V., Belgium	Phase 1
Actelion	Phase 3
Actelion	Phase 1

See all ponesimod clinical trials

Pharmacology for ponesimod

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

Anatomical Therapeutic Chemical (ATC) Classes for ponesimod

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

US Patents and Regulatory Information for ponesimod

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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
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-002	Mar 18, 2021		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-010	Mar 18, 2021		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-003	Mar 18, 2021		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-003	Mar 18, 2021		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-005	Mar 18, 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

Expired US Patents for ponesimod

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-006	Mar 18, 2021	⤷ Sign Up	⤷ Sign Up
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-003	Mar 18, 2021	⤷ Sign Up	⤷ Sign Up
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-001	Mar 18, 2021	⤷ Sign Up	⤷ Sign Up
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-006	Mar 18, 2021	⤷ Sign Up	⤷ Sign Up
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-010	Mar 18, 2021	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for ponesimod

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Janssen-Cilag International N.V.	Ponvory	ponesimod	EMEA/H/C/005163 Ponvory is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features.	Authorised	no	no	no	2021-05-19
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for ponesimod

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Country	Patent Number	Title	Estimated Expiration
Japan	5008777		⤷ Sign Up
Taiwan	201625242	Dosing regimen for a selective S1P1 receptor agonist	⤷ Sign Up
Slovenia	2344465		⤷ Sign Up
Ukraine	122063	ФАРМАЦЕВТИЧНА КОМБІНАЦІЯ, ЩО МІСТИТЬ СЕЛЕКТИВНИЙ АГОНІСТ РЕЦЕПТОРА S1P1 (PHARMACEUTICAL COMBINATION COMPRISING A SELECTIVE S1P1 RECEPTOR AGONIST)	⤷ Sign Up
Mexico	2017007651	COMBINACION FARMACEUTICA QUE COMPRENDE UN AGONISTA SELECTIVO DEL RECEPTOR S1P1. (PHARMACEUTICAL COMBINATION COMPRISING A SELECTIVE S1P1 RECEPTOR AGONIST.)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ponesimod

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3256125	PA2022505,C3256125	Lithuania	⤷ Sign Up	PRODUCT NAME: PONEZIMODAS; REGISTRATION NO/DATE: EU/1/21/1550 20210519
3256125	2022C/515	Belgium	⤷ Sign Up	PRODUCT NAME: PONESIMOD (IUPAC NAAM: (R)-5-(3-CHLORO-4-(2,3-DIHYDROXY-PROPOXY)- BENZ(Z)YLIDEEN)-2-((Z)-PROPYLIMINO)-3-O-TOLYL-THIAZOLIDIN-4-ON); AUTHORISATION NUMBER AND DATE: EU/1/21/1550 20210521
3256125	LUC00262	Luxembourg	⤷ Sign Up	PRODUCT NAME: PONESIMOD (NOM IUPAC : (R)-5-(3-CHLORO-4-(2,3-DIHYDROXY-PROPOXY)-BENZ(Z)YLIDENE)-2-((Z)-PROPYLIMINO)-3-O-TOLYL-THIAZOLIDIN-4-ONE); AUTHORISATION NUMBER AND DATE: EU/1/21/1550 20210521
3256125	C03256125/01	Switzerland	⤷ Sign Up	PRODUCT NAME: PONESIMOD; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68114 16.11.2021
3256125	18/2022	Austria	⤷ Sign Up	PRODUCT NAME: PONESIMOD; REGISTRATION NO/DATE: EU/1/21/1550 (MITTEILUNG) 20210521
>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.