daratumumab and hyaluronidase-fihj (Darzalex Faspro)
daratumumab and hyaluronidase-fihj is an FDA-licensed reference biologic from Janssen Biotech, 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
Darzalex Faspro daratumumab and hyaluronidase-fihj
Janssen Biotech, Inc.
- Approved
- May 01, 2020
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for daratumumab and hyaluronidase-fihj, in chronological order.
Reference approval
Approval date of the reference daratumumab and hyaluronidase-fihj product.
6 yr 2 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 1 yr 8 mo
Frequently asked questions
Are there biosimilars approved for daratumumab and hyaluronidase-fihj (Darzalex Faspro)?
No 351(k) biosimilars or interchangeable biosimilars referencing daratumumab and hyaluronidase-fihj are listed in the FDA Purple Book yet.
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Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.