ETRASIMOD ARGININE - Generic Drug Details

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

Etrasimod arginine is the generic ingredient in one branded drug marketed by Pfizer and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Etrasimod arginine has ninety-seven patent family members in twenty-seven countries.

Two suppliers are listed for this compound.

Summary for ETRASIMOD ARGININE

International Patents:	97
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
DailyMed Link:	ETRASIMOD ARGININE at DailyMed

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

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.

Pharmacology for ETRASIMOD ARGININE

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

US Patents and Regulatory Information for ETRASIMOD ARGININE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	VELSIPITY	etrasimod arginine	TABLET;ORAL	216956-001	Oct 12, 2023		RX	Yes	Yes			Y	Y
Pfizer	VELSIPITY	etrasimod arginine	TABLET;ORAL	216956-001	Oct 12, 2023		RX	Yes	Yes			Y	Y
Pfizer	VELSIPITY	etrasimod arginine	TABLET;ORAL	216956-001	Oct 12, 2023		RX	Yes	Yes
Pfizer	VELSIPITY	etrasimod arginine	TABLET;ORAL	216956-001	Oct 12, 2023		RX	Yes	Yes
Pfizer	VELSIPITY	etrasimod arginine	TABLET;ORAL	216956-001	Oct 12, 2023		RX	Yes	Yes			Y	Y

International Patents for ETRASIMOD ARGININE

Country	Patent Number	Title	Estimated Expiration
Brazil	112017027656	sal de l-arginina cristalina de ácido (r)-2-(7-(4-ciclopentil-3-(trifluorometil)benzilóxi)-1,2,3,4-tetra-hidrociclo-penta[b]indol-3-il)acético (composto 1) para uso em distúrbios associados ao receptor de s1p1
Brazil	PI0916812	derivados do ácido 1,2,3,4-tetra-hidrociclo-penta[b]indol-3-il)acético substituído úteis no tratamento de distúrbios autoimunes e inflamatórios, seu uso e composição farmacêutica que os compreende
Mexico	2017016530	SAL CRISTALINA DE L-ARGININA DEL ACIDO (R)-2-(7-(4-CICLOPENTIL-3-( TRIFLUOROMETIL)BENCILOXI)-1,2,3,4-TETRAHIDROCICLOPENTA[B]INDOL-3- IL)ACETICO (COMPUESTO1) PARA SER UTILIZADA EN TRANSTORNOS ASOCIADOS CON EL RECEPTOR DE ESFINGOSINA-1-FOSFATO 1 (S1P1). (CRYSTALLINE L-ARGININE SALT OF (R)-2-(7-(4-CYCLOPENTYL-3-(TRIFLUO ROMETHYL)BENZYLOXY)-1,2,3,4-TETRAHYDROCYCLO-PENTA[B]INDOL-3-YL)A CETIC ACID(COMPOUND1) FOR USE IN SIPI RECEPTOR-ASSOCIATED DISORDERS.)
World Intellectual Property Organization (WIPO)	2016112075
South Korea	20220084423	자가면역성 및 염증성의 장애의 치료에 유용한 치환된 1,2,3,4-테트라히드로시클로펜타[ｂ]인돌-3-일)아세트산 유도체 (1234-[]-3- SUBSTITUTED 1234- TETRAHYDROCYCLOPENTA[]INDOL-3-YL ACETIC ACID DERIVATIVES USEFUL IN THE TREATMENT OF AUTOIMMUNE AND INFLAMMATORY DISORDERS)