New I-MAK report documents how drug manufacturers extend monopoly pricing — costing Medicare and patients billions

Case studies of blockbuster drugs reveal a repeatable playbook of patent strategies that delay competition well beyond original patent terms

NEW YORK, NY, UNITED STATES, April 7, 2026 /EINPresswire.com/ -- The Initiative for Medicines, Access & Knowledge (I-MAK) today published The Monopoly Extension Menu, a new report documenting the specific, deliberate schemes drug manufacturers use to delay generic and biosimilar competition and extend monopoly-level pricing long after the underlying invention has been patented.

Through detailed case studies of three drugs — Pomalyst, Darzalex, and Trelegy Ellipta — that together cost Medicare nearly $10 billion annually, I-MAK identified three distinct tactics manufacturers use to suppress competition:

- Patent thickets: Layered patent filings and patent litigation settlements have kept U.S. generic drug prices double those in Europe for two additional years, generating approximately $5 billion for Bristol Myers Squibb during that window alone.

- Formulation switch: Reformulating a drug and shifting 85% of patients to the modified version created a product insulated from biosimilar competition that could potentially extend exclusivity for more than twelve years beyond the original patent term.

- Drug Combination and Device Patent Evergreening Scheme: Combining three individual drugs alongside an array of patented inhaler devices can delay generic entry, even if the patents on the underlying active ingredients expire. This creates a secondary exclusivity barrier that operates on its own timeline.
The report argues these anti-competitive schemes built around patents are not unintended loopholes. They are a menu of options that are available, predictable, and increasingly routine for manufacturers to deploy across the pharmaceutical market. While the Inflation Reduction Act represented a meaningful step toward addressing drug prices, I-MAK's analysis finds that it does not close these pathways that keep drug prices higher for longer.

"High drug prices are too often justified by the pharmaceutical industry as an unavoidable cost of drug development and doing business. What the industry doesn't want the public to know is how they keep their prices high. What we document in this report is how companies are able to keep charging high prices and why these are deliberate choices," says Tahir Amin, co-founder and CEO of I-MAK. "Manufacturers have access to a well-worn menu of patenting schemes to extend their monopolies and block competition – and current law allows them to get away with it. Until Congress changes how the current patent system functions, companies will continue to dine out on this monopoly menu while patients and taxpayers are left footing a bill in the billions."

Simon Tam
I-MAK
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