FDA Purple Book · Reference family
galcanezumab-gnlm (Emgality)
galcanezumab-gnlm is an FDA-licensed reference biologic from Eli Lilly and Company. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2019
Reference approved
Reference product
351(a)BLA 761063
Emgality galcanezumab-gnlm
Eli Lilly and Company
- Approved
- Jun 04, 2019
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for galcanezumab-gnlm, in chronological order.
Reference approval
Approval date of the reference galcanezumab-gnlm product.
7 yr 1 mo ago
Frequently asked questions
Are there biosimilars approved for galcanezumab-gnlm (Emgality)?
No 351(k) biosimilars or interchangeable biosimilars referencing galcanezumab-gnlm 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.
