FDA Purple Book · Reference family
margetuximab-cmkb (Margenza)
margetuximab-cmkb is an FDA-licensed reference biologic from MacroGenics Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2020
Reference approved
Reference product
351(a)BLA 761150
Margenza margetuximab-cmkb
MacroGenics Inc.
- Approved
- Dec 16, 2020
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for margetuximab-cmkb, in chronological order.
Reference approval
Approval date of the reference margetuximab-cmkb product.
5 yr 6 mo ago
Frequently asked questions
Are there biosimilars approved for margetuximab-cmkb (Margenza)?
No 351(k) biosimilars or interchangeable biosimilars referencing margetuximab-cmkb 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.