metreleptin (Myalept)
metreleptin is an FDA-licensed reference biologic from Chiesi Farmaceutici S.p.A.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2014
Reference approved
Reference product
Myalept metreleptin
Chiesi Farmaceutici S.p.A.
- Approved
- Feb 24, 2014
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for metreleptin, in chronological order.
Reference approval
Approval date of the reference metreleptin product.
12 yr 5 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
5 yr 4 mo ago
Frequently asked questions
Are there biosimilars approved for metreleptin (Myalept)?
No 351(k) biosimilars or interchangeable biosimilars referencing metreleptin are listed in the FDA Purple Book yet.
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