Sitagliptin

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."

Enlicitide has potential to be first approved oral PCSK9 inhibitor designed to help meet critical unmet needs for patients and will be offered at an affordable price to eligible Americans through a direct-to-patient program Merck has committed more than $70 billion in U.S. investments to boost domestic production and innovation RAHWAY, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced a historic agreement with the Trump administration to ensure its prescription medicines are both accessible and affordable for Americans. This agreement enables Merck to continue its long-standing commitment to develop and deliver life-changing medicines and vaccines, and ensure Americans have access to those innovations at lower costs. “As an American company, Merck is proud to work with the Trump administration to further secure our country’s position as a world leader in biopharmaceutical innovation. Today’s agreement marks a pivotal step in ensuring Americans can access medicines they need at lower costs,” said Robert M. Davis, chairman and chief executive officer, Merck. “For too long, global pricing imbalances have shifted the financial burden of groundbreaking research and development onto the U.S. health care system and ultimately, American patients. Merck remains committed to expanding access and improving affordability across the system.” Merck is working with the administration to reduce disparities in drug prices between the U.S. and other nations so American patients no longer shoulder a disproportionate share of the cost of innovation. Merck is voluntarily addressing all four components of the president’s July letter and taking steps that will help ensure Americans can benefit from lower prices and broader access to prescription medicines. Information on Merck’s agreement with the Trump administration Merck plans to provide key products through a direct-to-patient program at affordable prices for eligible patients in the U.S. This currently includes JANUVIA, JANUMET and JANUMET XR, and will be expanded in the future to include enlicitide decanoate following FDA approval. JANUVIA, JANUMET and JANUMET XR will be available to eligible American patients at a cash price — approximately 70% off of the current list price — through a direct-to-patient program. Enlicitide, a novel candidate to lower LDL cholesterol, was designed to deliver PCSK9 antibody-like efficacy in an easy-to-use daily pill. Although existing injectable PCSK9 inhibitors are effective, they remain widely underused. The cardiovascular (CV) epidemic is the leading cause of deaths in America with heart attacks and stroke contributing to most of the CV deaths — one person dies every 36 seconds from cardiovascular disease. If approved, we intend to make enlicitide broadly available as an affordable option for American patients to help address the CV epidemic. Additionally, the company reached an understanding with the U.S. Department of Commerce to delay Section 232 tariffs for three years, enabling the company to make investments in the United States to reshore manufacturing for American patients. Merck investments in American innovation Merck has accelerated its commitment to U.S. innovation and manufacturing, building on its 15 manufacturing and R&D facilities and a strong workforce in the U.S. of more than 30,000. The company has invested over $12 billion in U.S. manufacturing since 2017 and $81 billion in U.S.-based R&D since 2018, supporting tens of thousands of American jobs. Over the next several years, Merck will invest more than $70 billion in capital and R&D spending, including at least $12 billion in capital expenditures, to drive long-term growth and strengthen the U.S. position as a global leader in biopharmaceutical innovation. This includes Merck’s recent announcements of manufacturing facilities in Virginia, Kansas and Delaware, which alone will create 1,200 full-time jobs and support 15,000 construction jobs. About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world — and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit and connect with us on X (formerly Twitter) , Facebook , Instagram , YouTube and LinkedIn . Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2024 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site ( ). Appendix Generic product names are provided below. JANUMET (sitagliptin and metformin HCl) JANUMET XR (sitagliptin and metformin HCI extended-release) JANUVIA (sitagliptin) Contacts Media Contacts: John Cummins john.cummins2@merck.com Melissa Moody melissa.moody@merck.com Investor Contacts: Peter Dannenbaum (732) 594-1579 Steven Graziano (732) 594-1583