Skip to content
Assyro AI
Purple Book reference family · 351(a) biologic

trastuzumab (Herceptin)

trastuzumab is an FDA-licensed reference biologic from Genentech, Inc., with 6 approved follow-on biologics.

351(a) biologicBLA 103792 Genentech, Inc.
Biosimilars
6
Interchangeables
0
Listed patents
4
Reference approved
1998

Reference product

Originator biologic
351(a)BLA 103792

Herceptin trastuzumab

Genentech, Inc.

View full reference-product record
Approved
Marketing
Disc*
Center
CDER
Patents
4 listed

Molecular structure

RCSB Protein Data Bank

Experimental 3D structure for trastuzumab from the RCSB Protein Data Bank (PDB 1N8Z).

3D molecular structure of trastuzumab (PDB entry 1N8Z)

Interactive biological assembly from PDB entry 1N8Z. 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 1N8Z details

Exclusivity & patent cliffs

Protection horizon

  1. Reference approval

    Approval date of the reference trastuzumab product.

    28 yr 5 mo ago

  2. Orphan exclusivity ends

    7-year orphan-drug exclusivity window.

    9 yr 1 mo ago

  3. Patent 10,808,037 expires

    Published Purple Book patent expiration.

    in 1 yr 10 mo

  4. Patent 11,078,294 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 10,662,237 expires

    Published Purple Book patent expiration.

    in 4 yr 11 mo

Biosimilars & interchangeables for trastuzumab

Follow-on biologics
Biosimilars and interchangeable biosimilars referencing trastuzumab.
ProductProper nameApplicantTypeBLAApproved
Ogivritrastuzumab-dkstBiocon Biologics Inc.Biosimilar 351(k)761074
Herzumatrastuzumab-pkrbCELLTRION, Inc.Biosimilar 351(k)761091
Kanjintitrastuzumab-annsAmgen Inc.Biosimilar 351(k)761073
Ontruzanttrastuzumab-dttbSamsung Bioepis Co., Ltd.Biosimilar 351(k)761100
Trazimeratrastuzumab-qyypPfizer Ireland Pharmaceuticals Unlimited CompanyBiosimilar 351(k)761081
Hercessitrastuzumab-strfAccord BioPharma Inc.Biosimilar 351(k)761346

Published patents

Purple Book patent list
Published Purple Book patents for trastuzumab.
PatentExpiresIn
10,808,037in 1 yr 10 mo
11,078,294in 1 yr 10 mo
8,574,869in 1 yr 10 mo
10,662,237in 4 yr 11 mo

trastuzumab: 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 trastuzumab.

Related FDA reference tools

Agent CTA Background

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

Book a Demo