Question 1

Is there a generic for Etrasimod arginine?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Etrasimod arginine. It is available as 1 brand (NDA) application.

Question 2

What is the reference-listed drug for Etrasimod arginine?

Accepted Answer

VELSIPITY (NDA 216956, PFIZER) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Etrasimod arginine?

Accepted Answer

The Orange Book lists 9 patents against Etrasimod arginine products, with the earliest listed expiry in 2029. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

Does Etrasimod arginine have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 1 marketing-exclusivity period for Etrasimod arginine. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

Question 5

What dosage forms of Etrasimod arginine are approved?

Accepted Answer

Etrasimod arginine is approved in the following dosage form: tablet.

Patent	Expires	In	Type
9126932	Jul 22, 2029	in 3 yr 2 mo	U-3732
8580841	Mar 05, 2030	in 3 yr 9 mo	SubstanceProduct
12377071	Jan 06, 2036	in 9 yr 8 mo	U-4255
11007175	Jan 06, 2036	in 9 yr 8 mo	U-3730
12156866	Jan 06, 2036	in 9 yr 8 mo	U-4047
11884626	Jun 21, 2036	in 10 yr 2 mo	U-3731
10676435	Jun 21, 2036	in 10 yr 2 mo	U-3731
11091435	Jun 21, 2036	in 10 yr 2 mo	SubstanceProduct
10301262	Jun 21, 2036	in 10 yr 2 mo	SubstanceProduct

Etrasimod arginine

Brand (NDA) products · tablet

Marketing exclusivity (1)

Listed patents (9)

Etrasimod arginine — frequently asked questions

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.