Assyro AI

Orange Book product · Brand (NDA)

VELSIPITY

ETRASIMOD ARGININE

Brand (NDA)NDA 216956RX PFIZER

At a glance

Oct 12, 2023

Approved

Brand (NDA)

Application

Not listed

TE code

9

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Oct 12, 2023

    2 yr 9 mo ago

  2. Today

  3. Exclusivity ends · NCE

    New chemical entity exclusivity (5 years)

    Oct 12, 2028

    in 2 yr 4 mo

  4. Patent 9126932 expires

    Listed method-of-use patent (U-3732) expiration.

    Jul 22, 2029

    in 3 yr 2 mo

  5. Patent 8580841 expires

    Listed drug substance patent expiration.

    Mar 05, 2030

    in 3 yr 9 mo

  6. Patent 11007175 expires

    Listed method-of-use patent (U-3730) expiration.

    Jan 06, 2036

    in 9 yr 8 mo

  7. Patent 12156866 expires

    Listed method-of-use patent (U-4047) expiration.

    Jan 06, 2036

    in 9 yr 8 mo

  8. Patent 12377071 expires

    Listed method-of-use patent (U-4255) expiration.

    Jan 06, 2036

    in 9 yr 8 mo

  9. Patent 10301262 expires

    Listed drug substance patent expiration.

    Jun 21, 2036

    in 10 yr 2 mo

  10. Patent 10676435 expires

    Listed method-of-use patent (U-3731) expiration.

    Jun 21, 2036

    in 10 yr 2 mo

  11. Patent 11091435 expires

    Listed drug substance patent expiration.

    Jun 21, 2036

    in 10 yr 2 mo

  12. Patent 11884626 expires

    Listed method-of-use patent (U-3731) expiration.

    Jun 21, 2036

    in 10 yr 2 mo

Pharmaceutical detail

Active ingredient

ETRASIMOD ARGININE

Strength

EQ 2MG BASE

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 216956

Product number

001

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Marketing exclusivity (1)

  • NCENew chemical entity exclusivity (5 years)

    Oct 12, 2028

    in 2 yr 4 mo

Listed patents (9)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9126932Jul 22, 2029in 3 yr 2 mo
U-3732
8580841Mar 05, 2030in 3 yr 9 mo
SubstanceProduct
11007175Jan 06, 2036in 9 yr 8 mo
U-3730
12156866Jan 06, 2036in 9 yr 8 mo
U-4047
12377071Jan 06, 2036in 9 yr 8 mo
U-4255
10301262Jun 21, 2036in 10 yr 2 mo
SubstanceProduct
10676435Jun 21, 2036in 10 yr 2 mo
U-3731
11091435Jun 21, 2036in 10 yr 2 mo
SubstanceProduct
11884626Jun 21, 2036in 10 yr 2 mo
U-3731
Agent CTA Background

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