PONESIMOD - Generic Drug Details

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 Janssen Pharms and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

One supplier is listed for this compound.

Summary for PONESIMOD

International Patents:	141
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
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

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

US Patents and Regulatory Information for PONESIMOD

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Pharms	PONVORY	ponesimod	TABLET;ORAL	213498-008	Mar 18, 2021		RX	Yes	No
Janssen Pharms	PONVORY	ponesimod	TABLET;ORAL	213498-004	Mar 18, 2021		RX	Yes	No
Janssen Pharms	PONVORY	ponesimod	TABLET;ORAL	213498-003	Mar 18, 2021		RX	Yes	No
Janssen Pharms	PONVORY	ponesimod	TABLET;ORAL	213498-003	Mar 18, 2021		RX	Yes	No			Y	Y

EU/EMA Drug Approvals for PONESIMOD

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

International Patents for PONESIMOD

Country	Patent Number	Title	Estimated Expiration
Japan	6244497
South Korea	20110071133	CRYSTALLINE FORMS OF (R)-5-[3-CHLORO-4-(2,3-DIHYDROXY-PROPOXY)-BENZ[Z]YLIDENE]-2-([Z]-PROPYLIMINO)-3-0-TOLYL-THIAZOLIDIN-4-ONE
Taiwan	201022220	Crystalline forms
Eurasian Patent Organization	039629	ФАРМАЦЕВТИЧЕСКАЯ КОМБИНАЦИЯ, СОДЕРЖАЩАЯ СЕЛЕКТИВНЫЙ АГОНИСТ РЕЦЕПТОРА S1P1 (PHARMACEUTICAL COMBINATION COMPRISING A SELECTIVE S1P1 RECEPTOR AGONIST)

Supplementary Protection Certificates for PONESIMOD

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3256125	122022000027	Germany		PRODUCT NAME: PONESIMOD ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1550 20210519
3256125	LUC00262	Luxembourg		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	22C1021	France		PRODUCT NAME: PONESIMOD ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/21/1550 20210521
3256125	CA 2022 00026	Denmark		PRODUCT NAME: PONESIMOD (IUPAC NAME: (R)-5-(3-CHLORO-4-(2,3-DIHYDROXY-PROPOXY)-BENZ(Z)YLIDENE)-2-((Z)-PROPYLIMINO)-3-OTOLYL-; REG. NO/DATE: EU/1/21/1550 20210521