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 4 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 1 yr 6 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.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.