AbbVie Gains Health Canada Approval for 6‑Month 45 mg LUPRON DEPOT® Strength

ABBV
November 17, 2025

AbbVie announced that Health Canada has approved a new 6‑month 45 mg strength of its LUPRON DEPOT® leuprolide acetate, extending the drug’s dosing options for advanced prostate cancer. The new formulation delivers the same therapeutic effect as the existing 7.5 mg (1‑month), 22.5 mg (3‑month), and 30 mg (4‑month) strengths, but with a longer duration that reduces the need for frequent clinic visits.

The approval comes at a time when AbbVie’s oncology segment is a key growth driver. In the third quarter of 2025, the company reported $1.682 billion in global oncology revenue, a slight 0.3% decline from the same period in 2024. Despite the modest drop, the oncology portfolio remains a critical part of AbbVie’s strategy to diversify beyond its flagship immunology products, which generated $15.776 billion in net revenue for the quarter, up 9.1% year‑over‑year.

Strategically, the 6‑month formulation enhances patient convenience and adherence, two factors that can translate into higher market share in Canada’s largest prostate‑cancer market. By offering a longer‑acting option, AbbVie can differentiate itself from competitors that rely on shorter‑acting GnRH agonists, potentially capturing patients who prefer fewer injections and reducing healthcare resource utilization. This aligns with AbbVie’s broader focus on patient‑centric solutions and portfolio expansion.

Rami Fayed, Vice President and General Manager of AbbVie Canada, noted that the new strength “provides clinicians and patients with a more convenient, single‑injection option that can improve adherence and reduce clinic visits.” The company’s CEO, Robert A. Michael, has emphasized that such product extensions support AbbVie’s long‑term growth strategy, especially as the company navigates the loss of exclusivity for Humira and seeks to strengthen its oncology and immunology pipelines.

Financially, the new strength is expected to contribute modest incremental revenue in the Canadian market, complementing AbbVie’s strong earnings momentum. The company has raised its full‑year adjusted EPS guidance to $10.61–$10.65 for 2025, reflecting confidence in continued revenue growth and margin stability. While the oncology segment’s revenue growth is modest, the addition of a 6‑month LUPRON DEPOT® aligns with AbbVie’s goal of expanding its high‑margin oncology offerings and supports the company’s overall strategy to maintain profitability amid competitive headwinds and rising in‑process R&D expenses.

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