FDA Purple Book · Reference family
oprelvekin (Neumega)
oprelvekin is an FDA-licensed reference biologic from Wyeth Pharmaceuticals Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
1997
Reference approved
Reference product
351(a)BLA 103694
Neumega oprelvekin
Wyeth Pharmaceuticals Inc.
- Approved
- Nov 25, 1997
- Marketing
- Disc
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for oprelvekin, in chronological order.
Reference approval
Approval date of the reference oprelvekin product.
28 yr 11 mo ago
Frequently asked questions
Are there biosimilars approved for oprelvekin (Neumega)?
No 351(k) biosimilars or interchangeable biosimilars referencing oprelvekin are listed in the FDA Purple Book yet.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.