Sitagliptin

MSD says it has a “line of sight to over $70bn” in potential commercial opportunity by the mid-2030s. HJBC via Shutterstock.com. Despite posting strong results in the final quarter of 2025, MSD (Merck & Co) has cut its 2026 guidance more than analysts had expected as the drugmaker prepares for the loss of exclusivity of several of its medicines. MSD reported Q4 global sales of $16.4bn, a 5% increase from the same period in 2024. Full-year sales in 2025 grew 1% to reach $65bn. While year-end results outperformed consensus analyst expectations, investor buoyancy was overshadowed by the 2026 sales forecast. The big pharma company anticipates global sales of between $65.5bn and $67bn.  The higher end of this range falls short of the average analyst estimate of $67.6bn, as per LSEG data. As has been the case for recent years, cancer blockbuster Keytruda (pembrolizumab) was the top-performing drug in the big pharma company’s portfolio. The immunotherapy reached $31.7bn in global sales, driving much of the company’s higher-than-expected 2025 performance, especially its strong Q4. Keytruda is one of MSD’s products facing loss of exclusivity later this decade , while type 2 diabetes drugs Januvia (sitagliptin) and neuromuscular blockage Bridion (sugammadex) lose patent protection in 2026. Eyes have therefore been firmly on the company’s pipeline and M&A activity in search of revenue replacement. Reacting to the results, Citi analysts wrote: “We note 2026 guidance came in below expectations as investor interest remains on the anticipated Keytruda loss of exclusivity and the strategy to offset the impact with new launches and pipeline catalysts.” GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence MSD conducted two large deals in 2025 as it seeks to replenish its portfolio. This included a $10bn buyout of Verona Pharma and a $9.2bn acquisition of antiviral developer Cidara Therapeutics in August and November last year, respectively. In January 2026, there were suggestions that MSD was looking to buy Revolution Medicines for up to $32bn, though talks reportedly ended after price disagreements. Speaking on an earnings call, CEO Rob Davis said: “Our belief in our ability to have sustainable growth once we get past the loss of exclusivity is as high as it’s ever been. We have early-stage pipeline assets that we will be reading out in the next two years. Plus, we’ve conducted additional business development.” Keytruda’s strong performance was joined by MSD’s new drug Winrevair, which is used to treat pulmonary arterial hypertension (PAH). The injection recorded $467m in sales for Q4, up 133% from the same period a year earlier. While it was recently approved in 2024, Winrevair is touted as a major growth driver for the company as it transitions reliance away from Keytruda. As a result of pipeline progress and recent acquisitions, MSD says it has a “line of sight to over $70bn” in potential commercial opportunity by the mid-2030s. MSD’s Gardasil vaccines did not perform well, seeing sales decline by 39% in 2025, though this was in line with analyst expectations. The company said this was due to the lower demand in China and Japan. The HPV jab’s revenue could face more pressure in 2026, following the US Centers for Disease Control and Prevention’s (CDC’s) recent changes to the paediatric vaccine schedule .

Just days before the US Health Resources and Services Administration (HRSA) was set to launch a pilot evaluating a rebate-based model of the 340B discount programme, its rollout has been blocked by a federal judge.The American Hospital Association (AHA), along with the Maine Hospital Association and four safety-net hospitals, filed suit at the beginning of December to block the pilot's Jan. 1, 2026 launch, arguing that a rebate system "would inflict hundreds of millions of dollars’ worth of annual costs on hospitals." Judge Lance Walker of the US District Court for the District of Maine sided with the plaintiffs on Monday, issuing an injunction against the pilot as its "economic impact and disruption to services is substantial and… sufficient to demonstrate irreparable injury."Rebate pushCurrently, 340B-eligible hospitals — which serve uninsured and low-income patients — receive significant discounts on drugs upfront, but drugmakers have argued that the programme is rife with abuse, and that large hospital systems exploit the discounts by inflating prices for both uninsured patients and insurers. And for drugs set to debut lower Medicare prices next year thanks to negotiations under the Inflation Reduction Act (IRA), pharmaceutical companies are concerned their products may be subjected to duplicative price concessions if they are also purchased at the 340B price. To avoid potential abuse and "double-dipping," several pharmas, including Johnson & Johnson, Eli Lilly and Bristol Myers Squibb have pushed to adopt a model where hospitals would be required to pay the full amount of a drug upfront, then file for a rebate afterwards. Though their efforts to move to a rebate model were initially rebuffed, HRSA announced in July it would launch a pilot programme "to test…in a methodical and thoughtful approach…a fair and transparent 340B rebate model process." In October, nine therapeutics were accepted for the pilot, including three from J&J: Stelara (ustekinumab), an IL-12/IL-23 inhibitor approved for several autoimmune diseases; oral anticoagulant Xarelto (rivaroxaban); and blood cancer treatment Imbruvica (ibrutinib), which it co-commercialises with AbbVie. Other pilot participants include BMS's anticoagulant Eliquis (apixaban), Boehringer Ingelheim and Eli Lilly's diabetes and heart failure treatment Jardiance (empagliflozin), Merck & Co.'s diabetes drug Januvia (sitagliptin), Novo Nordisk's NovoLog family of insulin products, AstraZeneca's diabetes drug Farxiga (dapagliflozin), and Amgen's Enbrel (etanercept), which is used to treat chronic inflammatory diseases such as rheumatoid arthritis, psoriasis, psoriatic arthritis, ankylosing spondylitis and juvenile idiopathic arthritis. Each product selected for the 340B rebate model pilot was also part of the first round of Medicare price negotiations, which is also set to go into effect on Jan. 1, 2026.'Fatal' errorWhile the Administrative Procedure Act (APA) provides a pathway for US agencies to launch new programmes, it requires that the same be "reasonable and reasonably explained," with an agency tasked with keeping a "record of the relevant factors it considered and…a reasoned explanation for its course of action."However, Walker found that HRSA's rebate pilot did not meet these "vanishingly minimal requirements.""The Agency’s roll out has involved a rather threadbare administrative record that likely fails to consider and reasonably explain the impact of a rebate model on 340B hospitals, who rely on upfront price concessions to stretch few resources as far as possible to serve rural and poor communities," he wrote in his ruling. In the suit, AHA claimed that a rebate model would "impose vast administrative costs to submit, track, recover, and potentially dispute the rebates," while also draining hospitals "of huge sums of money through payments to drug companies that the hospitals then must wait to have refunded," and which drugmakers "have every incentive to slow and stymie the issuance of rebates." Walker took issue with the fact that HRSA is still evaluating administrative costs of its pilot. "This failure to consider administrative costs before approving the manufacturers’ applications under the Rebate Program is fatal under the APA," he concluded. "Defendants cannot fly the plane before they build it."