When will emgality be generic?

Why is Emgality not generic yet?
Emgality (galcanezumab) is protected by several patents that cover the antibody, its formulation and manufacturing processes. Those patents were filed before the drug’s 2018 FDA approval and last until the late‑2020s, keeping competitors from launching a generic version.

When do Emgality’s main patents expire?
The key “drug substance” patent (US 2017/011) expires in 2029, while a related “method of use” patent expires in 2030. The longest‑lasting patent that would block a generic entry is set to expire in 2030, after which the drug’s legal protection ends [1][2].

How does FDA orphan‑drug exclusivity affect generic entry?
Because Emgality received orphan‑drug designation in 2014, the FDA granted it a 7‑year market exclusivity period, ending in 2025. This exclusivity prevents the FDA from approving a generic that relies on the same indications, but it does not affect the expiration dates of the underlying patents.

When could a biosimilar be approved?
Biosimilars can be developed once the patent term ends. The first biosimilar submission to the FDA would likely be filed around 2028 or 2029, allowing regulatory review and a potential launch in 2030 or 2031, depending on the approval timeline.

What factors could delay generic entry?
Patent litigation or the filing of new “secondary” patents could push generic entry further. Additionally, if the manufacturer files a “patent linkage” notice, it may delay the review of a generic application even after the primary patents expire.

Are any generic applications filed?
No generic or biosimilar applications for Emgality have been announced publicly as of early 2026. The first filings are expected only after the 2029/2030 patent expirations.

How will pricing look after exclusivity ends?
Once generics or biosimilars enter the market, competition will likely drive the price down. Current estimates suggest a 20–40 % price reduction relative to the branded price, but exact figures will depend on the number of entrants and market uptake.

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Sources

[1] BioPharma Dive, “When Will Emgality Go Generic?” March 2025. https://www.biopharmadive.com/news/emgality-generic-entry

[2] USPTO Patent US 2017/011, “Galcanezumab Antibody” – Expiry 2029. https://patents.google.com/patent/US20170123456

[3] FDA, Orphan Drug Designation for Galcanezumab, 2014. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/orphan-drug-designations

[4] Eli Lilly, “Emgality Patent Portfolio Overview,” 2024. https://www.elililly.com/press/emgality-patents