Purple Book reference family · 351(a) biologic
galcanezumab-gnlm (Emgality)
galcanezumab-gnlm is an FDA-licensed reference biologic from Eli Lilly and Company.
351(a) biologicBLA 761063 Eli Lilly and Company
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2019
Reference product
Originator biologic
351(a)BLA 761063
Emgality galcanezumab-gnlm
Eli Lilly and Company
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference galcanezumab-gnlm product.
7 yr 3 mo ago
galcanezumab-gnlm: frequently asked questions
Reference exclusivity, biosimilars, interchangeability, and patents for this molecule, from the FDA Purple Book.
Built from official FDA Purple Book records (monthly downloads, the Advanced Search interface, and the published Patent List), with reference-product, license-type, and exclusivity context for galcanezumab-gnlm.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.

