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
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

International Patents for ETRASIMOD ARGININE

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3310760	SEL L-ARGININE CRISTALLIN D'ACIDE (R)-2-(7-(4-CYCLOPENTYL-3-(TRIFLUOROMÉTHYL)BENZYLOXY)-1,2,3,4-TÉTRAHYDROCYCLO-PENTA[B]INDOL-3-YL)ACÉTIQUE (COMPOSÉ 1) POUR UNE UTILISATION DANS DES TROUBLES ASSOCIÉS AU RÉCEPTEUR DE S1P1 (CRYSTALLINE L-ARGININE SALT OF (R)-2-(7-(4-CYCLOPENTYL-3-(TRIFLUOROMETHYL)BENZYLOXY)-1,2,3,4-TETRAHYDROCYCLO-PENTA[B]INDOL-3-YL)ACETIC ACID(COMPOUND1) FOR USE IN SIPI RECEPTOR-ASSOCIATED DISORDERS)
South Korea	20230160955	Ｓ1Ｐ1 수용체-관련 장애에서의 사용을 위한 의 결정성 Ｌ-아르기닌 염 (11 - -2-7-4--3--1234--[]-3- 1 - CRYSTALLINE L-ARGININE SALT OF R-2-7-4-CYCLOPENTYL-3-TRIFLUOROMETHYLBENZYLOXY-1234-TETRAHYDROCYCLO-PENTA[B]INDOL-3-YLACETIC ACIDCOMPOUND1 FOR USE IN SIPI RECEPTOR-ASSOCIATED DISORDERS)
Japan	2020196756	Ｓ１Ｐ１レセプター関連障害における使用のための（Ｒ）−２−（７−（４−シクロペンチル−３−（トリフルオロメチル）ベンジルオキシ）−１，２，３，４−テトラヒドロシクロペンタ［ｂ］インドール−３−イル）酢酸（化合物１）の結晶性Ｌ−アルギニン塩 (CRYSTALLINE L-ARGININE SALT OF (R)-2-(7-(4-CYCLOPENTYL-3-(TRIFLUOROMETHYL)BENZYLOXY)-1,2,3,4-TETRAHYDROCYCLOPENTA[b]INDOL-3-YL)ACETIC ACID (COMPOUND 1) FOR USE IN S1P1 RECEPTOR-ASSOCIATED DISORDERS)