Viatris received FDA approval on December 18, 2025 for its octreotide acetate injectable suspension, a long‑acting formulation used to treat acromegaly and certain tumor‑related complications. The approval marks the company’s fourth injectable product to receive regulatory clearance in 2025, adding to iron sucrose, paclitaxel and liposomal amphotericin B.
Octreotide acetate is a complex biologic‑like molecule that competes with the branded Sandostatin® LAR Depot. By offering a cost‑effective generic alternative, Viatris positions itself in a niche market where pricing power is limited but demand for specialty generics remains steady, especially as payers seek lower‑cost options for chronic endocrine disorders.
The approval aligns with Viatris’ strategy to grow its specialty‑generic segment through technically demanding products. It also demonstrates the company’s ability to navigate the FDA’s stringent biologics pathway, a capability that can enhance investor confidence in its hybrid model of mature generics and innovative offerings.
In the third quarter of 2025, Viatris reported total revenue of $3.8 billion, flat on a reported basis and down 1% on a divestiture‑adjusted operational basis compared with the same period in 2024. Adjusted earnings per share fell 11% to $0.67, and adjusted EBITDA declined 10% to $1.2 billion, largely due to the “Indore Impact” stemming from an FDA warning letter and import alert at its Indian manufacturing facility. The new octreotide approval is expected to add a new revenue stream that could offset these headwinds over the coming years.
Philippe Martin, Viatris’ Chief R&D Officer, said the approval “highlights our progress in developing high‑value specialty generics and reinforces our commitment to delivering affordable treatment options.” CFO Doretta Mistras added that the company’s “operational execution and disciplined capital allocation” remain strong, even as it navigates regulatory and supply‑chain challenges.
Analysts continue to maintain a consensus buy/hold stance on Viatris, with a price target of $12.17. Barclays initiated coverage on December 9, 2025, assigning an overweight rating and a $15 price target, reflecting confidence in the company’s specialty‑generic pipeline and its ability to manage cost pressures.
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