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CMS released a proposed rule on Friday aimed at closing the 'evergreening' loophole where drugmakers extend patent protection through formulation changes. The rule could bring subcutaneous versions of Merck's Keytruda and Bristol Myers Squibb's Opdivo into Medicare price negotiations for 2029 alongside their intravenous versions. However, new formulations may be exempt if intravenous biosimilars enter the market. Halozyme expects minimal impact on its royalty revenue from this rule.
The Supreme Court ruled Thursday that Hikma Pharmaceuticals did not violate patent law by marketing a copycat version of Amarin's heart drug Vascepa using a 'skinny label.' The 9-0 decision found that Hikma did not 'induce' use of its generic in an unapproved indication for which Amarin still held patents. The ruling could help protect generic drugmakers from legal threats arising from skinny labeling, a tactic used to speed products to market before broad patent expirations. Amarin had alleged Hikma induced infringement by not doing enough to discourage use of its drug for reducing heart risk. A Delaware court initially dismissed the case, but an appeals court overturned that decision. The Supreme Court's decision raises the bar for challenging skinny labels, according to legal experts.
The U.S. Supreme Court ruled 9-0 on Thursday that Hikma Pharmaceuticals did not induce patent infringement in marketing a generic version of Vascepa, supporting the 'skinny label' practice. The ruling may raise the bar for challenging skinny labels, affecting the competitive landscape of the generic drug industry.
Evaluate's Orphan Drugs Report forecasts orphan drug sales will exceed $400 billion by 2032, representing over 21% of global prescription drug sales, up from 15% in 2022. Despite a temperamental FDA and competition from blockbusters, policy wins like IRA amendments and the reauthorization of the Rare Pediatric Disease Priority Review Voucher program support growth. Johnson & Johnson is expected to lead with nearly $31 billion in orphan sales, while Argenx is forecast to enter the top ten. The orphan pipeline remains strong, with candidates projected to generate over $100 billion in 2032, though their share of total prescription drug sales is expected to fall from a 2027 peak of 30% to 22% in 2032. China's rising share of FDA orphan designations and complex regulatory standards pose challenges, but fundamentals remain solid with over 95% of rare diseases lacking approved treatments.
Evaluate has released the "2026 Rare Disease Drug Report," noting that despite a turbulent regulatory and pricing environment, rare disease drug sales are steadily rising, expected to account for over 21% of global prescription drug sales by 2032, exceeding $400 billion. Policy tailwinds (such as IRA amendments and PRV program reauthorization) support growth, but the FDA has raised evidence standards for cell and gene therapies, and the share of FDA rare disease designations held by Chinese sponsors has risen from less than 5% in 2020 to 15% in 2025, intensifying competition. The pipeline value exceeds $100 billion, but the market share of rare disease drugs is expected to decline from a peak of 30% in 2027 to 22% by 2032.
With the largest patent cliff in history approaching, pharmaceutical companies are rethinking mature product management. Strategic outsourcing of regulatory, safety, and quality functions can reduce costs, free internal teams for innovation, and extend product value. Experts from Cencora discuss benefits including lower SG&A expenses, access to specialized expertise, and guidance on reigniting brand value. Case studies show significant workload and cost reductions while maintaining compliance.
For a long time, pharmaceutical companies have managed mature brands only at a basic maintenance level. However, as the largest patent cliff in history approaches, the revenue share contributed by mature products is expected to continue rising. This article explores how strategic outsourcing of regulatory, safety, and quality functions can help pharmaceutical companies reduce operating costs, access scalable specialized capabilities, and revitalize the value of mature products.
Vertex's Journavx, the first new pain drug in decades, has revived interest in pain research, but its modest sales and the difficulty of developing better painkillers pose challenges. Companies like Latigo and SiteOne are pursuing ion channel blockers, while researchers explore drug combinations. The field must soon deliver assets worth rallying around beyond Journavx to sustain major investments.
Biotech investors have historically bet on M&A, shorting companies that try to market their own drugs. But BridgeBio, Argenx, Insmed, and Madrigal have proven they can sell medicines better than expected, joining the sector's more valuable companies. This shift represents a maturation for biotech, potentially giving younger firms more leverage in deal negotiations and making the sector more appealing to generalist investors.