Assyro AI
FDA Purple Book · Reference family

Immune Globulin Intravenous, Human-slra (Asceniv)

Immune Globulin Intravenous, Human-slra is an FDA-licensed reference biologic from ADMA Biologics, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2019

Reference approved

Reference product

351(a)BLA 125590

Asceniv Immune Globulin Intravenous, Human-slra

ADMA Biologics, Inc.

Approved
Apr 01, 2019
Marketing
Rx
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for Immune Globulin Intravenous, Human-slra, in chronological order.

  1. Reference approval

    Approval date of the reference Immune Globulin Intravenous, Human-slra product.

    7 yr 3 mo ago

Frequently asked questions

Are there biosimilars approved for Immune Globulin Intravenous, Human-slra (Asceniv)?

No 351(k) biosimilars or interchangeable biosimilars referencing Immune Globulin Intravenous, Human-slra 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