Generation Patient publishes new report finding terminal disclaimers on most drug patents, asserted in 74% of 2020 drug litigation

Washington, D.C., May 6, 2026. Generation Patient today published a new report, "Patent thickets increase costs and delay access to medicines for young adult patients," documenting how drug companies use terminal disclaimers to build patent thickets that delay generic competition and keep American drug prices high.

Read our report on patent thickets here.

Read a summary of our case study on rifaximin (Xifaxan) here.

Generation Patient analyzed 7,836 drug patents listed in the FDA's Orange Book with application filing dates between 2002 and 2022. Nearly 70 percent of patents filed between 2017 and 2021 carry terminal disclaimers, up from 36 percent for patents filed between 2002 and 2006. The most recent edition of the Orange Book, listing 6,247 active patents as of March 2026, shows 59.4 percent with terminal disclaimers.

Approximately 74 percent of district court drug patent cases filed in 2020 involved at least one terminally disclaimed patent, up from 45 percent in 2011. Across the decade, 60 percent of all drug patent disputes involved at least one terminally disclaimed patent.

“Young adult patients across America deserve prescription medications that allow them not only to manage lifelong conditions but to finish school, to build their careers, and to ultimately thrive into adulthood. Brand‑name pharmaceutical companies have built dense patent thickets around key drugs like rifaximin (Xifaxan) to delay generic competition, keeping prices for IBS-D in the thousands of dollars per course and leaving many patients dependent on copay cards or going without treatment. 

For young adults who are often in school or early in their careers, frequently under‑insured, and navigating transitions off parental coverage, these patent games result in financial toxicity. This report sets out an even greater case for the ETHIC Act, which would ensure that young adult patients have access to affordable medicines while preserving incentives to innovate.”

- Sneha Dave, Executive Director at Generation Patient

"Drug patent thickets are larger and more pervasive than ever. Terminal disclaimers now appear on nearly 70 percent of new Orange Book drug patents, up from 36 percent two decades ago. These patents are routinely asserted in court to delay generic competition.

Congress must find bipartisan solutions to reduce high drug prices and the ETHIC Act offers a direct, narrowly tailored response to the well-documented anticompetitive gamesmanship that brand companies use to delay the entry of cheaper generic medicines. The data presented in this report show why Congress needs to pass the ETHIC Act.”

- Luis Gil Abinader, Policy Director at Generation Patient 

The Eliminating Thickets to Increase Competition (ETHIC) Act (S. 2276; H.R. 3269), a bipartisan and bicameral bill currently before Congress, would limit how many terminally disclaimed patents drug companies can assert against generic and biosimilar challengers. With data showing that terminally disclaimed patents are widespread and growing, the Generation Patient report finds that the ETHIC Act is a legislative response well-supported by the evidence.

Contact: Luis Gil Abinader, Policy Director at luis@generationpatient.org.