mecasermin rinfabate (Iplex)
mecasermin rinfabate is an FDA-licensed reference biologic from Insmed Incorporated. 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
Iplex mecasermin rinfabate
Insmed Incorporated
- Approved
- Dec 12, 2005
- Marketing
- Disc
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for mecasermin rinfabate, in chronological order.
Reference approval
Approval date of the reference mecasermin rinfabate product.
20 yr 9 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
13 yr 8 mo ago
Frequently asked questions
Are there biosimilars approved for mecasermin rinfabate (Iplex)?
No 351(k) biosimilars or interchangeable biosimilars referencing mecasermin rinfabate are listed in the FDA Purple Book yet.
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