Assyro AI
FDA Purple Book · Reference family

sutimlimab-jome (Enjaymo)

sutimlimab-jome is an FDA-licensed reference biologic from Recordati Rare Diseases, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2022

Reference approved

Reference product

351(a)BLA 761164

Enjaymo sutimlimab-jome

Recordati Rare Diseases, Inc.

Approved
Feb 04, 2022
Marketing
Rx
Center
CDER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for sutimlimab-jome, in chronological order.

  1. Reference approval

    Approval date of the reference sutimlimab-jome product.

    4 yr 5 mo ago

  2. Orphan exclusivity ends

    7-year orphan-drug exclusivity window.

    in 2 yr 9 mo

Frequently asked questions

Are there biosimilars approved for sutimlimab-jome (Enjaymo)?

No 351(k) biosimilars or interchangeable biosimilars referencing sutimlimab-jome are listed in the FDA Purple Book yet.

Explore the full FDA Purple Book

Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.

Open the Purple Book tool