Why are some of the most expensive prescription drugs in Medicare insulated from competition long after their original patents should have expired?

The answer, according to a new report from I-MAK, is Big Pharma’s “Monopoly Extension Menu.”

The “Monopoly Extension Menu” is a set of legal and regulatory tactics that brand‑name drug manufacturers use to extend monopoly pricing and delay competition.

The menu consists of tactics to delay or block generic drugs and biosimilars from entering the market.

The report examines three high‑cost drugs that together account for nearly $10 billion in annual Medicare spending. Each illustrates a different “menu item,” but all arrive at the same result: unchecked monopoly power and higher costs for patients:

• Patent Thickets: After the core patent expired for oncology drug Pomalyst, the manufacturer collected dozens of follow‑on patents covering things like methods of use, formulations, and safety programs. These patents triggered waves of litigation and confidential settlements that blocked competition. While generics were already available in other parts of the world, Big Pharma used every trick in the book to block lower-cost options for an additional two years for American patients.
• Formulation Switch: Ahead of expected biosimilar competition for the original IV drug Darzalex, the manufacturer “product hopped” by introducing a subcutaneous formulation with new patent protection – essentially a new version of the same drug. Patients were rapidly shifted to the reformulated product, insulating about 85% of the market from biosimilar competition.
• Device Lock‑in: The manufacturer for Trelegy Ellipta, used to treat COPD and asthma, used the “evergreening” tactic to extend the monopoly period by more than seven years by changing how the drug was delivered. The drugmaker bundled known drug ingredients with a patented inhaler device, creating regulatory and patent barriers that prevent pharmacy‑level substitution, prolonging monopoly pricing even as individual components lost exclusivity.

These are just some of the ways brand drugmakers abuse the monopoly power provided to them. While the Trump Administration has taken meaningful steps to address high prescription drug prices, no action has been taken to stop Big Pharma’s underlying patent and regulatory practices that delay competition in the first place.

The authors conclude that,

“To prevent the continued extraction of billions in excess costs from the U.S. healthcare system and patients, policymakers must move beyond negotiating prices and take away the ability of pharmaceutical companies to dine out on the Monopoly Extension Menu. Only by addressing the structural failures in the patent and regulatory systems can we ensure that patients are not left footing a bill they can’t afford.”

Read the full report HERE.