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Purple Book reference family · 351(a) biologic

ustekinumab (Stelara)

ustekinumab is an FDA-licensed reference biologic from Janssen Biotech, Inc., with 8 approved follow-on biologics.

351(a) biologicBLA 125261 Janssen Biotech, Inc.
Biosimilars
0
Interchangeables
8
Listed patents
12
Reference approved
2009

Reference product

Originator biologic
351(a)BLA 125261

Stelara ustekinumab

Janssen Biotech, Inc.

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

Molecular structure

RCSB Protein Data Bank

Experimental 3D structure for ustekinumab from the RCSB Protein Data Bank (PDB 3HMW).

3D molecular structure of ustekinumab (PDB entry 3HMW)

Interactive biological assembly from PDB entry 3HMW. 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 3HMW details

Exclusivity & patent cliffs

Protection horizon

  1. Reference approval

    Approval date of the reference ustekinumab product.

    17 yr 3 mo ago

  2. Patent 6,902,734 expires

    Published Purple Book patent expiration.

    3 yr ago

  3. Patent 6,902,734 expires

    Published Purple Book patent expiration.

    3 yr ago

  4. Patent 8,852,889 expires

    Published Purple Book patent expiration.

    in 5 yr 10 mo

  5. Patent 8,852,889 expires

    Published Purple Book patent expiration.

    in 5 yr 10 mo

  6. Patent 9,475,858 expires

    Published Purple Book patent expiration.

    in 5 yr 10 mo

  7. Patent 9,475,858 expires

    Published Purple Book patent expiration.

    in 5 yr 10 mo

  8. Patent 9,217,168 expires

    Published Purple Book patent expiration.

    in 6 yr 7 mo

  9. Patent 9,217,168 expires

    Published Purple Book patent expiration.

    in 6 yr 7 mo

  10. Patent 9,663,810 expires

    Published Purple Book patent expiration.

    in 6 yr 7 mo

  11. Patent 9,663,810 expires

    Published Purple Book patent expiration.

    in 6 yr 7 mo

  12. Patent 10,961,307 expires

    Published Purple Book patent expiration.

    in 13 yr 2 mo

  13. Patent 10,961,307 expires

    Published Purple Book patent expiration.

    in 13 yr 2 mo

Biosimilars & interchangeables for ustekinumab

Follow-on biologics
Biosimilars and interchangeable biosimilars referencing ustekinumab.
ProductProper nameApplicantTypeBLAApproved
Wezlanaustekinumab-auubAmgen Inc.Interchangeable761331
Selarsdiustekinumab-aeknAlvotech USA Inc.Interchangeable761343
Pyzchivaustekinumab-ttweSamsung Bioepis Co., Ltd.Interchangeable761425
Imuldosaustekinumab-srlfAccord BioPharma Inc.Interchangeable761364
Yesintekustekinumab-kfceBiocon Biologics Inc.Interchangeable761406
Steqeymaustekinumab-stbaCELLTRION, Inc.Interchangeable761338
Otulfiustekinumab-aauzFresenius Kabi USA, LLCInterchangeable761379
Starjemzaustekinumab-hmnyBio-Thera Solutions, Ltd.Interchangeable761419

Published patents

Purple Book patent list
Published Purple Book patents for ustekinumab.
PatentExpiresIn
6,902,7343 yr ago
6,902,7343 yr ago
8,852,889in 5 yr 10 mo
8,852,889in 5 yr 10 mo
9,475,858in 5 yr 10 mo
9,475,858in 5 yr 10 mo
9,217,168in 6 yr 7 mo
9,217,168in 6 yr 7 mo
9,663,810in 6 yr 7 mo
9,663,810in 6 yr 7 mo
10,961,307in 13 yr 2 mo
10,961,307in 13 yr 2 mo

ustekinumab: 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 ustekinumab.

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