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Purple Book reference family · 351(a) biologic

omalizumab (Xolair)

omalizumab is an FDA-licensed reference biologic from Genentech, Inc., with 1 approved follow-on biologic.

351(a) biologicBLA 103976 Genentech, Inc.
Biosimilars
0
Interchangeables
1
Listed patents
8
Reference approved
2023

Reference product

Originator biologic
351(a)BLA 103976

Xolair omalizumab

Genentech, Inc.

View full reference-product record
Approved
Marketing
Rx
Center
CDER
Patents
8 listed

Molecular structure

RCSB Protein Data Bank

Experimental 3D structure for omalizumab from the RCSB Protein Data Bank (PDB 2XA8).

3D molecular structure of omalizumab (PDB entry 2XA8)

Interactive biological assembly from PDB entry 2XA8. Drag to rotate, scroll to zoom, and inspect the full atomic structure right here, with no need to leave the page.

Open in RCSB viewer PDB 2XA8 details

Exclusivity & patent cliffs

Protection horizon

  1. Reference approval

    Approval date of the reference omalizumab product.

    3 yr 1 mo ago

  2. Patent 10,034,940 expires

    Published Purple Book patent expiration.

    10 mo ago

  3. Patent 11,078,294 expires

    Published Purple Book patent expiration.

    in 1 yr 10 mo

  4. Patent 11,987,637 expires

    Published Purple Book patent expiration.

    in 1 yr 10 mo

  5. Patent 8,574,869 expires

    Published Purple Book patent expiration.

    in 1 yr 10 mo

  6. Patent 10,017,732 expires

    Published Purple Book patent expiration.

    in 7 yr 7 mo

  7. Patent 10,676,710 expires

    Published Purple Book patent expiration.

    in 7 yr 7 mo

  8. Patent 10,829,732 expires

    Published Purple Book patent expiration.

    in 7 yr 7 mo

  9. Patent 12,030,959 expires

    Published Purple Book patent expiration.

    in 17 yr 1 mo

Biosimilars & interchangeables for omalizumab

Follow-on biologics
Biosimilars and interchangeable biosimilars referencing omalizumab.
ProductProper nameApplicantTypeBLAApproved
Omlycloomalizumab-igecCELLTRION, Inc.Interchangeable761399

Published patents

Purple Book patent list
Published Purple Book patents for omalizumab.
PatentExpiresIn
10,034,94010 mo ago
11,078,294in 1 yr 10 mo
11,987,637in 1 yr 10 mo
8,574,869in 1 yr 10 mo
10,017,732in 7 yr 7 mo
10,676,710in 7 yr 7 mo
10,829,732in 7 yr 7 mo
12,030,959in 17 yr 1 mo

omalizumab: frequently asked questions

Reference exclusivity, biosimilars, interchangeability, and patents for this molecule, from the FDA Purple Book.

Built from official FDA Purple Book records (monthly downloads, the Advanced Search interface, and the published Patent List), with reference-product, license-type, and exclusivity context for omalizumab.

Related FDA reference tools

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