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Purple Book reference family · 351(a) biologic

margetuximab-cmkb (Margenza)

margetuximab-cmkb is an FDA-licensed reference biologic from MacroGenics Inc..

351(a) biologicBLA 761150 MacroGenics Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2020

Reference product

Originator biologic
351(a)BLA 761150

Margenza margetuximab-cmkb

MacroGenics Inc.

View full reference-product record
Approved
Marketing
Rx
Center
CDER
Patents
None listed

Exclusivity & patent cliffs

Protection horizon
  1. Reference approval

    Approval date of the reference margetuximab-cmkb product.

    5 yr 8 mo ago

margetuximab-cmkb: 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 margetuximab-cmkb.

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Agent CTA Background

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