Purple Book product · Reference 351(a)
Increlex
mecasermin
Aug 30, 2005
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.
Aug 30, 2005
21 yr 2 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Aug 30, 2012
14 yr 1 mo ago
Today
Pharmaceutical detail
Strength
40MG/4ML (10MG/ML)
Dosage form
Injection
Route
Subcutaneous
Presentation
Multi-Dose Vial
Center
CDER
License number
2393
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 Increlex have approved biosimilars?
No 351(k) biosimilars or interchangeable biosimilars referencing Increlex are listed in the FDA Purple Book yet.
What is Increlex's BLA number?
Increlex is licensed under BLA 21839, held by Eton Pharmaceuticals, Inc..
When was Increlex approved by the FDA?
Increlex was approved by the FDA on Aug 30, 2005.
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.
