naxitamab-gqgk (Danyelza)
naxitamab-gqgk is an FDA-licensed reference biologic from Y-mABs Therapeutics, 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
Danyelza naxitamab-gqgk
Y-mABs Therapeutics, Inc
- Approved
- Nov 25, 2020
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for naxitamab-gqgk, in chronological order.
Reference approval
Approval date of the reference naxitamab-gqgk product.
5 yr 7 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 1 yr 6 mo
Frequently asked questions
Are there biosimilars approved for naxitamab-gqgk (Danyelza)?
No 351(k) biosimilars or interchangeable biosimilars referencing naxitamab-gqgk 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.