Assyro AI

Orange Book product · Brand (NDA)

ICOTYDE

ICOTROKINRA HYDROCHLORIDE

Brand (NDA)NDA 220149RX JANSSEN BIOTECH

At a glance

Mar 17, 2026

Approved

Brand (NDA)

Application

Not listed

TE code

3

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Mar 17, 2026

    3 mo ago

  2. Today

  3. Exclusivity ends · NCE

    New chemical entity exclusivity (5 years)

    Mar 17, 2031

    in 4 yr 10 mo

  4. Patent 12552836 expires

    Listed drug substance patent expiration.

    Jul 12, 2039

    in 13 yr 3 mo

  5. Patent 11845808 expires

    Listed drug substance patent expiration.

    Jan 14, 2041

    in 14 yr 9 mo

  6. Patent 11939361 expires

    Listed drug product patent expiration.

    Nov 19, 2041

    in 15 yr 8 mo

Pharmaceutical detail

Active ingredient

ICOTROKINRA HYDROCHLORIDE

Strength

EQ 200MG BASE

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 220149

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)

    Mar 17, 2031

    in 4 yr 10 mo

Listed patents (3)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
12552836Jul 12, 2039in 13 yr 3 mo
SubstanceProduct
11845808Jan 14, 2041in 14 yr 9 mo
SubstanceU-4447
11939361Nov 19, 2041in 15 yr 8 mo
ProductU-4447
Agent CTA Background

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