Purple Book product · Reference 351(a)
Darzalex
daratumumab
Nov 16, 2015
Approved
Reference 351(a)
License type
Rx
Marketing
None
Listed patents
Sourced from the FDA Purple Book · verified Jul 02, 2026
Key dates
Approval
Approval date of this BLA submission.
Nov 16, 2015
10 yr 10 mo ago
Today
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Sep 26, 2026
in 2 mo
Pharmaceutical detail
Strength
400MG/20ML
Dosage form
Injection
Route
Intravenous
Presentation
Single-Dose Vial
Center
CDER
License number
1864
Product number
002
Submission type
Original
Supplement number
Not listed
Change type
Not listed
Reference product family
View full familyThis is the reference (originator) product. No biosimilars or interchangeables reference it in the Purple Book yet.
1 additional BLA record for this product (other strengths or presentations) are in the same reference family.
Patent list
No patent-list records were published for this product. The Purple Book patent list reflects the statutory patent exchange under the BPCIA and is not exhaustive.
Source provenance
- advanced-searchAdvanced Search · Jul 02, 2026
- monthly-downloadMonthly download · Jul 02, 2026
Change history
- v4Jul 02, 2026
- v3Jul 02, 2026
- v2Jul 02, 2026
Frequently asked questions
Does Darzalex have approved biosimilars?
No 351(k) biosimilars or interchangeable biosimilars referencing Darzalex are listed in the FDA Purple Book yet.
What is Darzalex's BLA number?
Darzalex is licensed under BLA 761036, held by Janssen Biotech, Inc..
When was Darzalex approved by the FDA?
Darzalex was approved by the FDA on Nov 16, 2015.
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.
