FDA Purple Book · Reference family
mepolizumab (Nucala)
mepolizumab is an FDA-licensed reference biologic from GlaxoSmithKline LLC. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2022
Reference approved
Reference product
351(a)BLA 761122
Nucala mepolizumab
GlaxoSmithKline LLC
- Approved
- Jan 22, 2022
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for mepolizumab, in chronological order.
Reference approval
Approval date of the reference mepolizumab product.
4 yr 7 mo ago
Frequently asked questions
Are there biosimilars approved for mepolizumab (Nucala)?
No 351(k) biosimilars or interchangeable biosimilars referencing mepolizumab are listed in the FDA Purple Book yet.
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- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.