Purple Book product · Reference 351(a)
Iplex
mecasermin rinfabate
Dec 12, 2005
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.
Dec 12, 2005
20 yr 11 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Dec 12, 2012
13 yr 9 mo ago
Today
Pharmaceutical detail
Strength
36MG/0.6ML (60MG/ML)
Dosage form
Injection
Route
Subcutaneous
Presentation
Single-Dose Vial
Center
CDER
License number
2188
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 Iplex have approved biosimilars?
No 351(k) biosimilars or interchangeable biosimilars referencing Iplex are listed in the FDA Purple Book yet.
What is Iplex's BLA number?
Iplex is licensed under BLA 21884, held by Insmed Incorporated.
When was Iplex approved by the FDA?
Iplex was approved by the FDA on Dec 12, 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.
