Purple Book product · Reference 351(a)
Praluent
alirocumab
Jul 24, 2015
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.
Jul 24, 2015
11 yr 2 mo ago
Today
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Apr 01, 2028
in 1 yr 9 mo
Pharmaceutical detail
Strength
150MG/ML
Dosage form
Injection
Route
Subcutaneous
Presentation
Pre-Filled Syringe
Center
CDER
License number
1760
Product number
004
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.
3 additional BLA records for this product (other strengths or presentations) are in the same reference family.
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
- advanced-searchAdvanced Search · Jul 02, 2026
- monthly-downloadMonthly download · Jul 02, 2026
Change history
- v3Jul 02, 2026
- v2Jul 02, 2026
Frequently asked questions
Does Praluent have approved biosimilars?
No 351(k) biosimilars or interchangeable biosimilars referencing Praluent are listed in the FDA Purple Book yet.
What is Praluent's BLA number?
Praluent is licensed under BLA 125559, held by Regeneron Pharmaceuticals, Inc..
When was Praluent approved by the FDA?
Praluent was approved by the FDA on Jul 24, 2015.
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.
