mecasermin (Increlex)
mecasermin is an FDA-licensed reference biologic from Eton Pharmaceuticals, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2005
Reference approved
Reference product
Increlex mecasermin
Eton Pharmaceuticals, Inc.
- Approved
- Aug 30, 2005
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for mecasermin, in chronological order.
Reference approval
Approval date of the reference mecasermin product.
21 yr 1 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
13 yr 11 mo ago
Frequently asked questions
Are there biosimilars approved for mecasermin (Increlex)?
No 351(k) biosimilars or interchangeable biosimilars referencing mecasermin are listed in the FDA Purple Book yet.
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