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EMGALITY

BLA

GALCANEZUMAB-GNLM | B761063 | ELI LILLY AND CO

1 product0 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

September 27, 2030(1547 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Sep. 27, 2030	Active	Computed

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Jan. 28, 20415323 days remaining

Based on latest discovered patent 10906983(composition) · relevance 50/100

Estimate based on AI-discovered patents. No patents are officially listed in the Purple Book for this product.

Discovered Patents

View all 4 patents →

4 AI-discovered patents, sorted by relevance.

Composition

(2)

55/1008183346Grant: 2012-05-22 | Exp: 2032-05-17

50/10010906983Grant: 2021-02-02 | Exp: 2041-01-28

Formulation

(1)

65/1008871201Grant: 2014-10-28 | Exp: 2034-10-23

Device

(1)

50/1009220845Grant: 2015-12-29 | Exp: 2035-12-24

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Purple Book (Biologics)

BLA 761063 | 3 presentations

351(a) ReferenceLicensedCDERInjection

Proper Name

galcanezumab-gnlm

Applicant

Eli Lilly and Company

Approval Date

27-Sep-18

Presentations

120MG/ML — Autoinjector (Subcutaneous)

120MG/ML — Pre-Filled Syringe (Subcutaneous)

100MG/ML — Pre-Filled Syringe (Subcutaneous)

Source: FDA Purple Book (purplebooksearch.fda.gov).

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Jun 9, 2026	SUPPL -13	View Letter (PDF)
Mar 25, 2025	SUPPL -10	View Letter (PDF)
May 25, 2022	SUPPL -6	View Letter (PDF)
Dec 6, 2019	SUPPL -4	View Letter (PDF)
Jun 5, 2019	SUPPL -3	View Letter (PDF)
Oct 1, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 120MG/ML

▴

INJECTABLE;INJECTION | Approved: 2018-09-27 00:00:00

No patent or exclusivity listings for this strength.