Purple Book product · Reference 351(a)
Adagen
pegademase bovine
Mar 21, 1990
Approved
Reference 351(a)
License type
Disc
Marketing
None
Listed patents
Sourced from the FDA Purple Book · verified Jul 02, 2026
Key dates
Approval
Approval date of this BLA submission.
Mar 21, 1990
36 yr 10 mo ago
Today
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Mar 21, 2097
in 71 yr 9 mo
Pharmaceutical detail
Strength
375UNITS/1.5ML (250UNITS/ML)
Dosage form
Injection
Route
Intramuscular
Presentation
Single-Dose Vial
Center
CDER
License number
2073
Product number
001
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.
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
- monthly-downloadMonthly download · Jul 02, 2026
Change history
- v2Jul 02, 2026
- v1Jul 02, 2026
Frequently asked questions
Does Adagen have approved biosimilars?
No 351(k) biosimilars or interchangeable biosimilars referencing Adagen are listed in the FDA Purple Book yet.
What is Adagen's BLA number?
Adagen is licensed under BLA 19818, held by Leadiant Biosciences, Inc.
When was Adagen approved by the FDA?
Adagen was approved by the FDA on Mar 21, 1990.
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.
