alirocumab (Praluent)
alirocumab is an FDA-licensed reference biologic from Regeneron Pharmaceuticals, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2015
Reference approved
Reference product
Praluent alirocumab
Regeneron Pharmaceuticals, Inc.
- Approved
- Jul 24, 2015
- Marketing
- Disc
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for alirocumab, in chronological order.
Reference approval
Approval date of the reference alirocumab product.
11 yr ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 1 yr 10 mo
Frequently asked questions
Are there biosimilars approved for alirocumab (Praluent)?
No 351(k) biosimilars or interchangeable biosimilars referencing alirocumab are listed in the FDA Purple Book yet.
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Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.